Controlling the HIV/AIDS epidemic: current status and global challenges
Identifieur interne : 002E27 ( Pmc/Corpus ); précédent : 002E26; suivant : 002E28Controlling the HIV/AIDS epidemic: current status and global challenges
Auteurs : Thorsten Demberg ; Marjorie Robert-GuroffSource :
- Frontiers in Immunology [ 1664-3224 ] ; 2012.
Abstract
This review provides an overview of the current status of the global HIV pandemic and strategies to bring it under control. It updates numerous preventive approaches including behavioral interventions, male circumcision (MC), pre- and post-exposure prophylaxis (PREP and PEP), vaccines, and microbicides. The manuscript summarizes current anti-retroviral treatment options, their impact in the western world, and difficulties faced by emerging and resource-limited nations in providing and maintaining appropriate treatment regimens. Current clinical and pre-clinical approaches toward a cure for HIV are described, including new drug compounds that target viral reservoirs and gene therapy approaches aimed at altering susceptibility to HIV infection. Recent progress in vaccine development is summarized, including novel approaches and new discoveries.
Url:
DOI: 10.3389/fimmu.2012.00250
PubMed: 22912636
PubMed Central: 3418522
Links to Exploration step
PMC:3418522Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Controlling the HIV/AIDS epidemic: current status and global challenges</title><author><name sortKey="Demberg, Thorsten" sort="Demberg, Thorsten" uniqKey="Demberg T" first="Thorsten" last="Demberg">Thorsten Demberg</name></author><author><name sortKey="Robert Guroff, Marjorie" sort="Robert Guroff, Marjorie" uniqKey="Robert Guroff M" first="Marjorie" last="Robert-Guroff">Marjorie Robert-Guroff</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">22912636</idno><idno type="pmc">3418522</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3418522</idno><idno type="RBID">PMC:3418522</idno><idno type="doi">10.3389/fimmu.2012.00250</idno><date when="2012">2012</date><idno type="wicri:Area/Pmc/Corpus">002E27</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002E27</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Controlling the HIV/AIDS epidemic: current status and global challenges</title><author><name sortKey="Demberg, Thorsten" sort="Demberg, Thorsten" uniqKey="Demberg T" first="Thorsten" last="Demberg">Thorsten Demberg</name></author><author><name sortKey="Robert Guroff, Marjorie" sort="Robert Guroff, Marjorie" uniqKey="Robert Guroff M" first="Marjorie" last="Robert-Guroff">Marjorie Robert-Guroff</name></author></analytic><series><title level="j">Frontiers in Immunology</title><idno type="eISSN">1664-3224</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>This review provides an overview of the current status of the global HIV pandemic and strategies to bring it under control. It updates numerous preventive approaches including behavioral interventions, male circumcision (MC), pre- and post-exposure prophylaxis (PREP and PEP), vaccines, and microbicides. The manuscript summarizes current anti-retroviral treatment options, their impact in the western world, and difficulties faced by emerging and resource-limited nations in providing and maintaining appropriate treatment regimens. Current clinical and pre-clinical approaches toward a cure for HIV are described, including new drug compounds that target viral reservoirs and gene therapy approaches aimed at altering susceptibility to HIV infection. Recent progress in vaccine development is summarized, including novel approaches and new discoveries.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Abdool Karim, Q" uniqKey="Abdool Karim Q">Q. Abdool Karim</name></author><author><name sortKey="Abdool Karim, S S" uniqKey="Abdool Karim S">S. S. 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Front Immunol</journal-id><journal-id journal-id-type="iso-abbrev">Front Immunol</journal-id><journal-id journal-id-type="publisher-id">Front. Immun.</journal-id><journal-title-group><journal-title>Frontiers in Immunology</journal-title></journal-title-group><issn pub-type="epub">1664-3224</issn><publisher><publisher-name>Frontiers Media S.A.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">22912636</article-id><article-id pub-id-type="pmc">3418522</article-id><article-id pub-id-type="doi">10.3389/fimmu.2012.00250</article-id><article-categories><subj-group subj-group-type="heading"><subject>Immunology</subject><subj-group><subject>Review Article</subject></subj-group></subj-group></article-categories><title-group><article-title>Controlling the HIV/AIDS epidemic: current status and global challenges</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Demberg</surname><given-names>Thorsten</given-names></name><xref ref-type="author-notes" rid="fn001"><sup>*</sup></xref></contrib><contrib contrib-type="author"><name><surname>Robert-Guroff</surname><given-names>Marjorie</given-names></name></contrib></contrib-group><aff><institution>Vaccine Branch, Section on Immune Biology of Retroviral Infection, National Cancer Institute, National Institutes of Health</institution><country>Bethesda, MD, USA</country></aff><author-notes><fn fn-type="edited-by"><p>Edited by: Marc H. V. Van Regenmortel, University of Strasbourg, France</p></fn><fn fn-type="edited-by"><p>Reviewed by: Marc H. V. Van Regenmortel, University of Strasbourg, France; Marc P. Girard, University Paris-Diderot, France; Catarina E. Hioe, New York University School of Medicine, USA</p></fn><corresp id="fn001">*Correspondence: Thorsten Demberg, Vaccine Branch, National Cancer Institute, National Institutes of Health, 41 Medlars Drive, Building 41, Room D804, Bethesda, MD 20892-5065, USA. e-mail: <email xlink:type="simple">dembergt@mail.nih.gov</email></corresp><fn fn-type="other" id="fn002"><p>This article was submitted to Frontiers in Immunotherapies and Vaccines, a specialty of Frontiers in Immunology.</p></fn></author-notes><pub-date pub-type="epub"><day>14</day><month>8</month><year>2012</year></pub-date><pub-date pub-type="collection"><year>2012</year></pub-date><volume>3</volume><elocation-id>250</elocation-id><history><date date-type="received"><day>18</day><month>5</month><year>2012</year></date><date date-type="accepted"><day>27</day><month>7</month><year>2012</year></date></history><permissions><copyright-statement>Copyright © 2012 Demberg and Robert-Guroff.</copyright-statement><copyright-year>2012</copyright-year><license license-type="open-access" xlink:href="http://www.frontiersin.org/licenseagreement"><license-p>This is an open-access article distributed under the terms of the <uri xlink:type="simple" xlink:href="http://creativecommons.org/licenses/by/3.0/">Creative Commons Attribution License</uri>, which permits use, distribution and reproduction in other forums, provided the original authors and source are credited and subject to any copyright notices concerning any third-party graphics etc.</license-p></license></permissions><abstract><p>This review provides an overview of the current status of the global HIV pandemic and strategies to bring it under control. It updates numerous preventive approaches including behavioral interventions, male circumcision (MC), pre- and post-exposure prophylaxis (PREP and PEP), vaccines, and microbicides. The manuscript summarizes current anti-retroviral treatment options, their impact in the western world, and difficulties faced by emerging and resource-limited nations in providing and maintaining appropriate treatment regimens. Current clinical and pre-clinical approaches toward a cure for HIV are described, including new drug compounds that target viral reservoirs and gene therapy approaches aimed at altering susceptibility to HIV infection. Recent progress in vaccine development is summarized, including novel approaches and new discoveries.</p></abstract><kwd-group><kwd>animal model</kwd><kwd>ART treatment</kwd><kwd>global strategies</kwd><kwd>HIV pandemic</kwd><kwd>prevention</kwd><kwd>vaccine development</kwd></kwd-group><counts><fig-count count="0"></fig-count><table-count count="6"></table-count><equation-count count="0"></equation-count><ref-count count="269"></ref-count><page-count count="17"></page-count><word-count count="17330"></word-count></counts></article-meta></front><body><sec id="s1"><title>Introduction</title><p>Beginning with the FDA approval of AZT in 1987 for HIV treatment and the subsequent development of combination therapies, millions of HIV infected people have been saved from progression to AIDS, and their quality of life has improved dramatically (Broder, <xref ref-type="bibr" rid="B33">2010</xref>). An outgrowth of the successful advances in AIDS treatment regimens is the recent finding that early initiation of antiretroviral therapy (ART) can reduce HIV transmission by 96% (Cohen et al., <xref ref-type="bibr" rid="B51">2011</xref>). Moreover, mother-to-child transmission can be prevented using anti-HIV drugs, as recently reviewed for low- and middle-income countries (Siegfried et al., <xref ref-type="bibr" rid="B214">2011</xref>; Tudor Car et al., <xref ref-type="bibr" rid="B233">2011</xref>; Santos et al., <xref ref-type="bibr" rid="B200">2012</xref>). The challenges of implementing such “treatment as prevention” strategies are many, however, as reviewed here. Overall, in addition to pursuing new developments in treatment, all available preventive measures as well as continued research efforts toward an efficacious HIV vaccine should be employed to effectively control the HIV/AIDS pandemic.</p></sec><sec><title>Facts and finances: the global challenge of HIV infection</title><p>Human immunodeficiency virus (HIV) infection and the incurable disease, acquired immunodeficiency syndrome (AIDS), present major global health problems. Approximately 34 million people worldwide are currently living with HIV, 1–1.2 million of these in the United States (Table <xref ref-type="table" rid="T1">1</xref>). The overall US HIV infection rate has remained steady since the 1990s with around 49,000 cases per year, the majority in men having sex with men (MSM) (Moore, <xref ref-type="bibr" rid="B151">2011</xref>; Morris and Little, <xref ref-type="bibr" rid="B153">2011</xref>; Prejean et al., <xref ref-type="bibr" rid="B184">2011</xref>). Moreover, the global HIV prevalence is expected to increase within the next 10 years (Yehia and Frank, <xref ref-type="bibr" rid="B262">2011</xref>), indicating that action on a national and international level is needed. The current standard of care is ART which requires daily medication to prevent disease progression and re-emergence of the virus. However, co-infection of HIV infected patients with tuberculosis or hepatitis as well as sexually transmitted diseases, together with problems in health care systems and infrastructure, have an impact on treatment success (Beauliere et al., <xref ref-type="bibr" rid="B21">2010</xref>; Obiako and Muktar, <xref ref-type="bibr" rid="B163">2010</xref>; Birbeck et al., <xref ref-type="bibr" rid="B27">2011</xref>; Boesecke and Vogel, <xref ref-type="bibr" rid="B30">2011</xref>; Finlayson et al., <xref ref-type="bibr" rid="B75">2011</xref>).</p><table-wrap id="T1" position="float"><label>Table 1</label><caption><p><bold>HIV/AIDS: facts and finance</bold>.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"><bold>Prevalence</bold></th><th align="left" rowspan="1" colspan="1"><bold>Currently HIV infected</bold></th><th align="left" rowspan="1" colspan="1"><bold>Newly infected (2010)</bold></th><th align="left" rowspan="1" colspan="1"><bold>AIDS deaths</bold></th><th align="left" rowspan="1" colspan="1"><bold>References</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">US</td><td align="left" rowspan="1" colspan="1">1.2 million</td><td align="left" rowspan="1" colspan="1">49 thousand</td><td align="left" rowspan="1" colspan="1">17 thousand (2009)</td><td align="left" rowspan="1" colspan="1">Prejean et al., <xref ref-type="bibr" rid="B184">2011</xref>, 1</td></tr><tr><td align="left" rowspan="1" colspan="1">Global</td><td align="left" rowspan="1" colspan="1">34 million</td><td align="left" rowspan="1" colspan="1">2.7 million</td><td align="left" rowspan="1" colspan="1">1.8 million (2010)</td><td align="left" rowspan="1" colspan="1">2</td></tr><tr><td align="left" rowspan="1" colspan="1"><bold>Treatment costs</bold></td><td align="left" rowspan="1" colspan="1"><bold>Per person/year</bold></td><td align="left" rowspan="1" colspan="1"><bold>Currently infected/year</bold></td><td align="left" rowspan="1" colspan="1"><bold>Newly infected/year</bold></td><td rowspan="1" colspan="1"></td></tr><tr><td align="left" rowspan="1" colspan="1">US</td><td align="left" rowspan="1" colspan="1">$10–$60 thousand</td><td align="left" rowspan="1" colspan="1">$14–$23 billion<xref ref-type="table-fn" rid="TN1"><sup>a</sup></xref></td><td align="left" rowspan="1" colspan="1">$1.47 billion<xref ref-type="table-fn" rid="TN2"><sup>b</sup></xref></td><td align="left" rowspan="1" colspan="1">Fleishman et al., <xref ref-type="bibr" rid="B76">2010</xref>; Gebo et al., <xref ref-type="bibr" rid="B83">2010</xref>; Chesson et al., <xref ref-type="bibr" rid="B48">2011</xref>; Hill et al., <xref ref-type="bibr" rid="B103">2011</xref>; Krentz and Gill, <xref ref-type="bibr" rid="B125">2012</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">Treatment through the global AIDS fund</td><td align="left" rowspan="1" colspan="1">First line ART: $487, second line ART: $1521</td><td align="left" rowspan="1" colspan="1">3.5 million people treated (2011): ~$1.9 billion</td><td align="left" rowspan="1" colspan="1">–</td><td align="left" rowspan="1" colspan="1">Stover et al., <xref ref-type="bibr" rid="B221">2011</xref></td></tr></tbody></table><table-wrap-foot><fn id="TN1"><label>a</label><p>Estimated cost for treatment of STDs and HIV.</p></fn><fn id="TN2"><label>b</label><p>Estimated using $30,000 per person, per year.</p></fn><p>1. <ext-link ext-link-type="uri" xlink:href="http://www.cdc.gov/hiv/resources.factsheets/us.htm">http://www.cdc.gov/hiv/resources.factsheets/us.htm</ext-link></p><p>2. <ext-link ext-link-type="uri" xlink:href="http://www.who.int/hiv/data/2011_epi_core_en.png">http://www.who.int/hiv/data/2011_epi_core_en.png</ext-link></p></table-wrap-foot></table-wrap><p>ART is expensive as illustrated by costs in the US that average $30,000/year/patient and are similarly high in European countries (Table <xref ref-type="table" rid="T1">1</xref>) (Fleishman et al., <xref ref-type="bibr" rid="B76">2010</xref>; Gebo et al., <xref ref-type="bibr" rid="B83">2010</xref>; Colombo et al., <xref ref-type="bibr" rid="B53">2011</xref>; Hill et al., <xref ref-type="bibr" rid="B103">2011</xref>; Krentz and Gill, <xref ref-type="bibr" rid="B125">2012</xref>). Despite multi-tier pricing models (Wirtz et al., <xref ref-type="bibr" rid="B257">2009</xref>), global costs for treatment are high (Table <xref ref-type="table" rid="T1">1</xref>) and current predictions call for over 1.7 billion dollars per year to fight HIV in low- and middle-income countries (Nunn et al., <xref ref-type="bibr" rid="B162">2007</xref>; Stover et al., <xref ref-type="bibr" rid="B221">2011</xref>). Moreover, the future of outside funding for treatment (e.g., PEPFAR, the President's Emergency Plan for AIDS Relief) under current global economic conditions is tenuous, as a drop in funding due to the weakened global economy has been reported with consequences for programs and patients in Africa (Voelker, <xref ref-type="bibr" rid="B242">2011</xref>; Wasswa, <xref ref-type="bibr" rid="B249">2011</xref>). Worldwide, treatment costs impact families, economies and health care systems. In the US alone, therapy for STDs and HIV cost from 14 to 23 billion dollars a year (Chesson et al., <xref ref-type="bibr" rid="B48">2011</xref>). HIV/AIDS is associated with poverty, lower education and minority populations (Torrone et al., <xref ref-type="bibr" rid="B226">2010</xref>; Vermund et al., <xref ref-type="bibr" rid="B240">2010</xref>; Dang et al., <xref ref-type="bibr" rid="B55">2011</xref>; Espinoza et al., <xref ref-type="bibr" rid="B68">2012</xref>). Only 15–17% people living with HIV have private insurance and nearly 30% in the US do not have any coverage (Espinoza et al., <xref ref-type="bibr" rid="B68">2012</xref>; <ext-link ext-link-type="uri" xlink:href="http://healthcare.gov/news/factsheets/affordable_care_act_people_hiv_aids.html">http://healthcare.gov/news/factsheets/affordable_care_act_people_hiv_aids.html</ext-link>). Since up to 21% of these groups would likely be starting treatment in an advanced disease state due to unawareness, late detection of infection (Moore, <xref ref-type="bibr" rid="B151">2011</xref>; Yehia and Frank, <xref ref-type="bibr" rid="B262">2011</xref>; Espinoza et al., <xref ref-type="bibr" rid="B68">2012</xref>) or being undocumented (Dang et al., <xref ref-type="bibr" rid="B55">2011</xref>) costs for therapy would be higher. Measures to prevent HIV infection at the outset would provide a significant financial benefit by lowering health care costs. Overall, finding measures to prevent HIV infection or affect a cure are of highest importance for the broadest benefit to public health (Long and Owens, <xref ref-type="bibr" rid="B138">2011</xref>).</p></sec><sec><title>Worldwide implementation of art</title><p>Effective treatment enables HIV infected individuals to be productive members of society, a critical economic benefit (Resch et al., <xref ref-type="bibr" rid="B192">2011</xref>). However, making treatment worldwide readily available is a challenge. Aside from high costs (Table <xref ref-type="table" rid="T1">1</xref>), successful initiation and maintenance of AIDS therapy in emerging countries and the developing world can be limited by political and sociological factors including instability of governments and health care systems, transportation problems and poor nutrition (Beauliere et al., <xref ref-type="bibr" rid="B21">2010</xref>; Obiako and Muktar, <xref ref-type="bibr" rid="B163">2010</xref>; Birbeck et al., <xref ref-type="bibr" rid="B27">2011</xref>). If disease is diagnosed late as often occurs in developing countries, treatment success can be diminished due to late stage AIDS, HIV-associated dementia and opportunistic infection requiring additional, often unavailable, treatment. Social barriers such as personal and family shame or blame and societal stigma, often paired with insufficient education on HIV/AIDS, can also prevent individuals from seeking treatment (Amuri et al., <xref ref-type="bibr" rid="B11">2011</xref>; Dang et al., <xref ref-type="bibr" rid="B55">2011</xref>; Winskell et al., <xref ref-type="bibr" rid="B255">2011</xref>; Espinoza et al., <xref ref-type="bibr" rid="B68">2012</xref>; Steward et al., <xref ref-type="bibr" rid="B220">2012</xref>).</p><p>The overall benefits outweigh by far the side effects of ART medications. However, in the course of treatment new problems surface and medical care has to be adjusted accordingly (Llibre et al., <xref ref-type="bibr" rid="B137">2009</xref>) which can be difficult in the developing world. ART can induce immune reconstitution inflammatory syndrome upon initiation, making the monitoring of CD4 T-cells, viral load, liver, and kidney function crucial for successful treatment (Kalyesubula and Perazella, <xref ref-type="bibr" rid="B114">2011</xref>; Keiser et al., <xref ref-type="bibr" rid="B116">2011</xref>; Barber et al., <xref ref-type="bibr" rid="B18">2012</xref>). Further, there is a tendency for HIV infected patients on ART to show increased kidney damage in addition to HIV associated nephropathy and cardiovascular disease. An increased risk for myocardial infarct has been attributed to the protease inhibitors lopinavir/ritonavir and the transcriptase inhibitor abacavir (Fichtenbaum, <xref ref-type="bibr" rid="B74">2010</xref>; Islam et al., <xref ref-type="bibr" rid="B107">2012a</xref>,<xref ref-type="bibr" rid="B108">b</xref>; Maggi et al., <xref ref-type="bibr" rid="B140">2012</xref>). Markers of systemic inflammation (c-reactive protein, IL-6), coagulation, and renal function are elevated in HIV infected patients independent of successful suppression of viremia (Neuhaus et al., <xref ref-type="bibr" rid="B159">2011</xref>; Bastard et al., <xref ref-type="bibr" rid="B20">2012</xref>). The elevated inflammatory markers can indicate ongoing low level viral replication in tissues only minimally reached by ART and subsequent cell-to-cell viral spread, as ART does not completely reverse T-cell activation (D'Ettorre et al., <xref ref-type="bibr" rid="B60">2011</xref>). In addition to T-cell activation, B-cell abnormalities and loss of memory B-cells persist despite long-term treatment with ART (Chong et al., <xref ref-type="bibr" rid="B49">2004</xref>; Moir and Fauci, <xref ref-type="bibr" rid="B150">2009</xref>). B-cell lymphomas and other cancers (e.g., squamous cell carcinoma) are increasing in HIV infected patients (Carbone et al., <xref ref-type="bibr" rid="B39">2009</xref>; Epeldegui et al., <xref ref-type="bibr" rid="B67">2010</xref>; Gervaz et al., <xref ref-type="bibr" rid="B85">2011</xref>; Tyerman and Aboulafia, <xref ref-type="bibr" rid="B235">2012</xref>) requiring additional treatment.</p><p>First line combination therapy, consisting of one non-nucleoside reverse transcriptase inhibitor (NNRTI) and two nucleoside reverse transcriptase inhibitors (NRTI) as recommended by the WHO, is often the only available form of treatment in low-income countries (<ext-link ext-link-type="uri" xlink:href="http://www.who.int/hiv/pub/arv/adult2010/en/index.html">www.who.int/hiv/pub/arv/adult2010/en/index.html</ext-link>). As of December, 2010, in 45 low- and middle-income countries excluding the Americas, of the 81% of patients receiving treatment, 97% were on first-line regimens (>54% on Nevirapine, Lamivudine and Stavudine, or Zidovudine) and only 2.9% on significantly more costly second line treatment regimens (<ext-link ext-link-type="uri" xlink:href="http://www.who.int/hiv/pub/progress_report2011/en/">www.who.int/hiv/pub/progress_report2011/en/</ext-link>). As a result, this can lead to the emergence of viral resistance to first line treatment. To combat this problem, frequent monitoring of viral loads and strict treatment adherence to the drug regimen are important, but can be problematic (Birbeck et al., <xref ref-type="bibr" rid="B27">2011</xref>). Over time despite treatment adherence and maintenance of viral load suppression, resistance develops in about 30% of patients. Not only does this result in treatment failure, the resistant viruses can be transmitted, cause new infections that are not controlled by the existing drug regimen (Hamilton et al., <xref ref-type="bibr" rid="B97">2012</xref>; von Wyl et al., <xref ref-type="bibr" rid="B243">2011</xref>), and jeopardize future treatment options (Chamberland et al., <xref ref-type="bibr" rid="B45">2011</xref>). Especially, concerning is the frequency of viral resistance to first-line ART that arises among children in resource poor countries (Sigaloff et al., <xref ref-type="bibr" rid="B216">2011</xref>). Resistance mutations vary depending on the type of drug regimen. However, regardless of the mechanism, resistance to ART develops inexorably, showing the urgent need not only for new treatments but also alternative preventive measures.</p></sec><sec><title>Additional approaches to prevent infection</title><p>In spite of the dramatic reports of preventing HIV transmission using early ART, other studies have suggested that testing and early treatment alone might not significantly reduce HIV transmission in the near future, as predicted by a study in Washington, DC (Walensky et al., <xref ref-type="bibr" rid="B244">2010</xref>), a current “hot-spot” of HIV infection (Greenberg et al., <xref ref-type="bibr" rid="B93">2009</xref>; Carr et al., <xref ref-type="bibr" rid="B40">2010</xref>; Hanna et al., <xref ref-type="bibr" rid="B98">2011</xref>). To be prudent, additional measures, of which there are several, would enhance the likelihood of successful prevention. Among the easiest is syringe and needle exchange programs. HIV is most commonly transmitted by sexual contact. However, transmission also occurs among intravenous drug users (IDU) via needle and syringe sharing (Nacopoulos et al., <xref ref-type="bibr" rid="B156">2010</xref>; Vlahov et al., <xref ref-type="bibr" rid="B241">2010</xref>). In the US approximately 12% of all new HIV infections per year occur in IDU (Adimora and Auerbach, <xref ref-type="bibr" rid="B3">2010</xref>). Syringe and needle exchange programs provide a simple, inexpensive preventive measure in this population (Adimora and Auerbach, <xref ref-type="bibr" rid="B3">2010</xref>; Nacopoulos et al., <xref ref-type="bibr" rid="B156">2010</xref>; Vlahov et al., <xref ref-type="bibr" rid="B241">2010</xref>).</p><p>Sexual transmission of HIV is best prevented by practicing safe sex or abstinence, both confounded by multifaceted behaviors. Failure to practice safe sex may be due to lack of knowledge about HIV infection and treatment, and perhaps the assumption that ART cures HIV (Owoaje et al., <xref ref-type="bibr" rid="B169">2011</xref>; Smith et al., <xref ref-type="bibr" rid="B219">2011</xref>). Other factors include gender inequity of woman, particularly in negotiating condom use, and partner violence (Jewkes et al., <xref ref-type="bibr" rid="B109">2010</xref>; East et al., <xref ref-type="bibr" rid="B65">2011</xref>; El-Bassel et al., <xref ref-type="bibr" rid="B66">2011</xref>; Fair and Vanyur, <xref ref-type="bibr" rid="B70">2011</xref>; Gakumo et al., <xref ref-type="bibr" rid="B81">2011</xref>; Swan and O'Connell, <xref ref-type="bibr" rid="B223">2011</xref>). Additionally, alcohol and substance abuse influence personality traits and risk behavior, and lower the frequency and ability to negotiate condom use (Tapert et al., <xref ref-type="bibr" rid="B225">2001</xref>; Kogan et al., <xref ref-type="bibr" rid="B122">2010</xref>; Finlayson et al., <xref ref-type="bibr" rid="B75">2011</xref>; Hagger-Johnson et al., <xref ref-type="bibr" rid="B96">2011</xref>; Maisto et al., <xref ref-type="bibr" rid="B141">2012</xref>; Rehm et al., <xref ref-type="bibr" rid="B190">2012</xref>). Selected clinical trials that address behavioral modification are listed in Table <xref ref-type="table" rid="T2">2</xref>. Behavioral modification is difficult, however, and mixed results have been obtained. Of five investigated interventions (billboards, peer education, magazines, radio broadcasts, and public outreach events) the latter three were significantly correlated with increased condom use, but the overall influence on behavior was limited (Hsu et al., <xref ref-type="bibr" rid="B104">2012</xref>). In another study, behavioral interventions among 725 HIV-positive women had no effect on increased condom use (Carvalho et al., <xref ref-type="bibr" rid="B43">2011</xref>). Behavioral interventions in the workplace, including voluntary counseling and testing to reduce risky sexual behavior, found no reduction in HIV incidence rate or frequency of unprotected sex, although, education did reduce unprotected sex, STDs and sex with commercial sex workers (Ojo et al., <xref ref-type="bibr" rid="B166">2011</xref>).</p><table-wrap id="T2" position="float"><label>Table 2</label><caption><p><bold>Selected clinical trials targeting behavior modification as a measure to prevent HIV infection</bold>.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"><bold>Behavioral intervention/counseling</bold></th><th align="left" rowspan="1" colspan="1"><bold>Status</bold></th><th align="left" rowspan="1" colspan="1"><bold>Phase</bold></th><th align="left" rowspan="1" colspan="1"><bold>Target group</bold></th><th align="left" rowspan="1" colspan="1"><bold>Alternate study ID</bold></th><th align="left" rowspan="1" colspan="1"><bold>Approach</bold></th><th align="left" rowspan="1" colspan="1"><bold>References</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">NCT00000931</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">MSM</td><td align="left" rowspan="1" colspan="1">HIVNET 015 EXPLORE</td><td align="left" rowspan="1" colspan="1">Behavioral intervention</td><td align="left" rowspan="1" colspan="1">Koblin et al., <xref ref-type="bibr" rid="B121">2004</xref>; (IIB trial results)</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00710060</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">At-risk populations</td><td align="left" rowspan="1" colspan="1">DAHBR 9A-ASGT</td><td align="left" rowspan="1" colspan="1">Community-level prevention program</td><td align="left" rowspan="1" colspan="1">Rotheram-Borus et al., <xref ref-type="bibr" rid="B195">2011</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00729391</td><td align="left" rowspan="1" colspan="1">Active</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Women</td><td align="left" rowspan="1" colspan="1">R01HD058320</td><td align="left" rowspan="1" colspan="1">Voluntary counseling and testing; equal attention control group</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00859144</td><td align="left" rowspan="1" colspan="1">Not yet recruiting</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Urban youth</td><td align="left" rowspan="1" colspan="1">CHAMPions, DAHBR 9A-ASPA</td><td align="left" rowspan="1" colspan="1">Behavioral intervention: be proud! be responsible!, becoming a responsible teen (BART)</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00279799</td><td align="left" rowspan="1" colspan="1">Unknown</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">African American females (age 14–20)</td><td align="left" rowspan="1" colspan="1">816-2003</td><td align="left" rowspan="1" colspan="1">AFIYA HIV prevention intervention</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00310973</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">II/III</td><td align="left" rowspan="1" colspan="1">MSM</td><td align="left" rowspan="1" colspan="1">DAHBR 9A-ASPG</td><td align="left" rowspan="1" colspan="1">Educational counseling</td><td align="left" rowspan="1" colspan="1">Kelly et al., <xref ref-type="bibr" rid="B117">2006</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01152281</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">II/III</td><td align="left" rowspan="1" colspan="1">At risk populations</td><td align="left" rowspan="1" colspan="1">Selective exposure</td><td align="left" rowspan="1" colspan="1">Meta-intervention to increase retention in prevention counseling</td><td align="left" rowspan="1" colspan="1">–</td></tr></tbody></table><table-wrap-foot><p>More information about the individual trials can be found using the NCT number and the following databases: <ext-link ext-link-type="uri" xlink:href="http://www.aidsinfo.nih.gov/clinical-trials">www.aidsinfo.nih.gov/clinical-trials</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.avac.org">http://www.avac.org</ext-link>.</p></table-wrap-foot></table-wrap><p>To augment safe sex practices and abstinence, oral/systemic pre-exposure prophylaxis (PREP) has been shown effective in preventing HIV infection both in non-human primates and humans (Tsai et al., <xref ref-type="bibr" rid="B231">1994a</xref>,<xref ref-type="bibr" rid="B232">b</xref>; Grant et al., <xref ref-type="bibr" rid="B90">2010</xref>; Myers and Mayer, <xref ref-type="bibr" rid="B155">2011</xref>). It must be used consciously and before sexual activity in order to achieve a sufficient inhibitor concentration. Reduction in HIV acquisition is dependent on adherence to PREP use and ranges from 21 to 73% (Krakower and Mayer, <xref ref-type="bibr" rid="B124">2011</xref>; Naswa and Marfatia, <xref ref-type="bibr" rid="B157">2011</xref>). Factors associated with PREP failure are similar to those of condom use, including failure to have the medication on hand and adherence (Golub et al., <xref ref-type="bibr" rid="B87">2010</xref>; van der Straten et al., <xref ref-type="bibr" rid="B237">2012</xref>). Questions concerning the implementation of PREP and guidelines for its use are both scientific (e.g., oral vs. mucosal) and policy related (e.g., insurance coverage of treatment expenses) (Myers and Mayer, <xref ref-type="bibr" rid="B155">2011</xref>; Naswa and Marfatia, <xref ref-type="bibr" rid="B157">2011</xref>). Current cost estimates for PREP for 100,000 high risk persons in the US are over $1 billion a year ($900 in medication costs per month) (Leibowitz et al., <xref ref-type="bibr" rid="B133">2011</xref>), making the implementation of PREP in tough economic times unlikely despite potential long-term benefits (Koppenhaver et al., <xref ref-type="bibr" rid="B123">2011</xref>). Further, emergence of drug resistance is a potential pitfall for PREP users but might have only a negligible impact as shown for MSM in the UK (Dolling et al., <xref ref-type="bibr" rid="B62">2011</xref>).</p><p>Post-exposure prophylaxis (PEP) or post-exposure prophylaxis following sexual exposure (PEPSE) must be used conscientiously and requires a long follow up interval of up to 6 months post-exposure as recommended by the CDC (<ext-link ext-link-type="uri" xlink:href="http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5402a1.htm">www.cdc.gov/mmwr/preview/mmwrhtml/rr5402a1.htm</ext-link>) (McCarty et al., <xref ref-type="bibr" rid="B147">2011</xref>). PEPSE awareness in high risk groups has increased significantly, but its use in general is low (Zablotska et al., <xref ref-type="bibr" rid="B263">2011</xref>). However, PEP after accidental exposure (e.g., needle stick injury) or for victims of sexual assault and rape has a proven track record of preventing infection. As for PREP, timing is critical. Treatment should not be delayed more than 72 h post exposure without a significant chance of infection. Table <xref ref-type="table" rid="T3">3</xref> lists selected clinical trials for PREP and PEP. For further information on PREP and PEP methods, strategies, costs, etc. see Fernandez-Montero et al. (<xref ref-type="bibr" rid="B72">2012</xref>).</p><table-wrap id="T3" position="float"><label>Table 3</label><caption><p><bold>Selected clinical trials investigating PrEP and PEP for prevention of HIV infection</bold>.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"><bold>Trial identifier</bold></th><th align="left" rowspan="1" colspan="1"><bold>Status</bold></th><th align="left" rowspan="1" colspan="1"><bold>Phase</bold></th><th align="left" rowspan="1" colspan="1"><bold>Target group</bold></th><th align="left" rowspan="1" colspan="1"><bold>Alternate study ID</bold></th><th align="left" rowspan="1" colspan="1"><bold>Component</bold></th><th align="left" rowspan="1" colspan="1"><bold>Comment/references</bold></th></tr></thead><tbody><tr><td align="left" colspan="7" rowspan="1"><bold>PrEP</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00458393</td><td align="left" rowspan="1" colspan="1">Active</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">MSM</td><td align="left" rowspan="1" colspan="1">Peru PrEP, iPREX</td><td align="left" rowspan="1" colspan="1">Emtricitabine/tenofovir disoproxil fumarate</td><td align="left" rowspan="1" colspan="1">44% efficacy; Grant et al., <xref ref-type="bibr" rid="B90">2010</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00931346</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">I/II</td><td align="left" rowspan="1" colspan="1">HIV discordant couples</td><td align="left" rowspan="1" colspan="1">IAVI E002</td><td align="left" rowspan="1" colspan="1">Emtricitabine/tenofovir disoproxil fumarate</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00557245</td><td align="left" rowspan="1" colspan="1">Active</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">HIV discordant couples</td><td align="left" rowspan="1" colspan="1">32528-A, IND 75,365</td><td align="left" rowspan="1" colspan="1">Emtricitabine/tenofovir disoproxil fumarate</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01473472</td><td align="left" rowspan="1" colspan="1">Not yet recruiting</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">MSM</td><td align="left" rowspan="1" colspan="1">IPERGAY</td><td align="left" rowspan="1" colspan="1">Emtricitabine and tenofovir disoproxil fumarate (truvada)</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01275443</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">People at risk for HIV</td><td align="left" rowspan="1" colspan="1">SSAT 040</td><td align="left" rowspan="1" colspan="1">TMC278 (rilpivirine), long-acting formulation</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" colspan="7" rowspan="1"><bold>PEP</bold></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00594646</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">IV</td><td align="left" rowspan="1" colspan="1">High-risk sexual contact</td><td align="left" rowspan="1" colspan="1">MK PEP 2007</td><td align="left" rowspan="1" colspan="1">Fixed-dose tenofovir and raltegravir</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00385645</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">IV</td><td align="left" rowspan="1" colspan="1">Accidental HIV exposure</td><td align="left" rowspan="1" colspan="1">DATEM-PEP</td><td align="left" rowspan="1" colspan="1">AZT-3TC + lopinavir-ritonavir vs. ZT-3TC + atazanavir</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01140880</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">MSM</td><td align="left" rowspan="1" colspan="1">MC08-LA-710-FRI</td><td align="left" rowspan="1" colspan="1">Emtricitabine and tenofovir disoproxil fumarate (truvada)</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00949234</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">High-risk sexual contact</td><td align="left" rowspan="1" colspan="1">PQUAD</td><td align="left" rowspan="1" colspan="1">Tenofovir + emtricitabine, lopinavir/ritonavir</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01087840</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">IV</td><td align="left" rowspan="1" colspan="1">MSM</td><td align="left" rowspan="1" colspan="1">RAL-NPEP</td><td align="left" rowspan="1" colspan="1">Raltegravir</td><td align="left" rowspan="1" colspan="1">–</td></tr></tbody></table><table-wrap-foot><p>More information about the individual trials can be found using the NCT number and the following databases: <ext-link ext-link-type="uri" xlink:href="http://www.aidsinfo.nih.gov/clinical-trials">www.aidsinfo.nih.gov/clinical-trials</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.avac.org">http://www.avac.org</ext-link>.</p></table-wrap-foot></table-wrap><p>Microbicide development for HIV prophylaxis is another active area of research. A number of microbicide candidates have been tested in clinical trials (Table <xref ref-type="table" rid="T4">4</xref>), but few have shown efficacy, and some have possibly enhanced HIV acquisition (Tao et al., <xref ref-type="bibr" rid="B224">2008</xref>; Abdool Karim et al., <xref ref-type="bibr" rid="B1">2010</xref>, <xref ref-type="bibr" rid="B2">2011</xref>; Pirrone et al., <xref ref-type="bibr" rid="B182">2011</xref>, <xref ref-type="bibr" rid="B181">2012</xref>). The gel base for microbicides must be chosen cautiously, as some can cause epithelial damage facilitating HIV infection (Begay et al., <xref ref-type="bibr" rid="B23">2011</xref>). The latest microbicides containing Tenofovir, a reverse transcriptase inhibitor, have shown promising but modest efficacy, as in the CAPRISA trial (Abdool Karim et al., <xref ref-type="bibr" rid="B1">2010</xref>). However, a recent clinical trial (VOICE, MTN-003) evaluating daily use of a vaginal gel containing Tenofovir in over 5000 woman was discontinued, as interim analysis showed no difference in HIV incidence rate compared to use of a placebo gel (Table <xref ref-type="table" rid="T4">4</xref>). Among new approaches, evaluation of topical 2-Hydroxypropyl-beta-cyclodextrin has shown promise in an animal model (Ambrose et al., <xref ref-type="bibr" rid="B10">2008</xref>), as have live lactobacilli engineered to secrete cyanovirin (Lagenaur et al., <xref ref-type="bibr" rid="B130">2011</xref>). The latter approach if successful might alleviate problems of adherence by reducing the need for application just prior sexual exposure. In the Carraguard trial self-reported microbicide use was 96%, but applicator testing revealed actual adherence was only 42% (Skoler-Karpoff et al., <xref ref-type="bibr" rid="B217">2008</xref>). Microbicides under development are incorporating other ART components such as integrase, protease or reverse transcriptase inhibitors. Antibodies are also being considered (Selhorst et al., <xref ref-type="bibr" rid="B207">2011</xref>). A major drawback of current microbicide clinical trials is that efficacy is only tested in heterosexual woman, not in high risk MSM where the majority of new infections occur in the US (Abdool Karim et al., <xref ref-type="bibr" rid="B1">2010</xref>; Krakower and Mayer, <xref ref-type="bibr" rid="B124">2011</xref>; Prejean et al., <xref ref-type="bibr" rid="B184">2011</xref>).</p><table-wrap id="T4" position="float"><label>Table 4</label><caption><p><bold>Selected clinical trials of microbicides</bold>.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"><bold>Microbicides</bold></th><th align="left" rowspan="1" colspan="1"><bold>Status</bold></th><th align="left" rowspan="1" colspan="1"><bold>Phase</bold></th><th align="left" rowspan="1" colspan="1"><bold>Type of prevention</bold></th><th align="left" rowspan="1" colspan="1"><bold>Alternate study ID</bold></th><th align="left" rowspan="1" colspan="1"><bold>Component</bold></th><th align="left" rowspan="1" colspan="1"><bold>Comment/references</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">NCT00262106</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Gel, vaginal</td><td align="left" rowspan="1" colspan="1">MDP301, ISRCTN64716212</td><td align="left" rowspan="1" colspan="1">PRO 2000/5 gel 0.5% and 2%</td><td align="left" rowspan="1" colspan="1">Not efficacious; McCormack et al., <xref ref-type="bibr" rid="B148">2010</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00153777</td><td align="left" rowspan="1" colspan="1">Terminated</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Gel, vaginal</td><td align="left" rowspan="1" colspan="1">CONRAD, C03-090</td><td align="left" rowspan="1" colspan="1">Cellulose sulfate gel (6%)</td><td align="left" rowspan="1" colspan="1">No protection, possible enhancement; Van Damme et al., <xref ref-type="bibr" rid="B236">2008</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00213083</td><td align="left" rowspan="1" colspan="1">Unknown</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Gel, vaginal</td><td align="left" rowspan="1" colspan="1">Population council #322</td><td align="left" rowspan="1" colspan="1">Carraguard (PC-515)</td><td align="left" rowspan="1" colspan="1">No protection; Skoler-Karpoff et al., <xref ref-type="bibr" rid="B217">2008</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00441298</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">Gel, vaginal</td><td align="left" rowspan="1" colspan="1">CAPRISA 004</td><td align="left" rowspan="1" colspan="1">Tenofovir 1% gel</td><td align="left" rowspan="1" colspan="1">39% efficacy; Abdool Karim et al., <xref ref-type="bibr" rid="B1">2010</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00705679</td><td align="left" rowspan="1" colspan="1">Active</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">Gel, vaginal and ART oral</td><td align="left" rowspan="1" colspan="1">VOICE, MTN-003</td><td align="left" rowspan="1" colspan="1">Tenofovir 1% vaginal gel, emtricitabine/tenofovir disoproxil fumarate</td><td align="left" rowspan="1" colspan="1">Vaginal gel arm halted, no efficacy; 1</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00740584</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">I/II</td><td align="left" rowspan="1" colspan="1">Gel, vaginal</td><td align="left" rowspan="1" colspan="1">SPL7013-003, DAIDS ES number 10730</td><td align="left" rowspan="1" colspan="1">3% SPL7013 gel (VivaGel)</td><td align="left" rowspan="1" colspan="1">Price et al., <xref ref-type="bibr" rid="B185">2011</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00850837</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">Gel, vaginal</td><td align="left" rowspan="1" colspan="1">AF 020</td><td align="left" rowspan="1" colspan="1">Acidform lubricant (Amphora)</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01283360</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">Gel, rectal</td><td align="left" rowspan="1" colspan="1">CONRAD, 1009001</td><td align="left" rowspan="1" colspan="1">Tenofovir 1% gel</td><td align="left" rowspan="1" colspan="1">–</td></tr></tbody></table><table-wrap-foot><p>More information about the individual trials can be found using the NCT number and the following databases: <ext-link ext-link-type="uri" xlink:href="http://www.aidsinfo.nih.gov/clinical-trials">www.aidsinfo.nih.gov/clinical-trials</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.avac.org">http://www.avac.org</ext-link>.</p><p>1. <ext-link ext-link-type="uri" xlink:href="http://www.niaid.nih.gov/news/newsreleases/2011/Pages/VOICEdiscontinued.aspx">http://www.niaid.nih.gov/news/newsreleases/2011/Pages/VOICEdiscontinued.aspx</ext-link></p></table-wrap-foot></table-wrap><p>Male circumcision (MC) has been recognized fairly recently as a potential preventive measure, but its overall impact may depend on the target population. Multiple trials in Africa have shown efficacy of MC in reducing HIV acquisition in heterosexual men by 38–66%, with uncircumcised men showing an 4-fold higher infection risk in sub-Saharan Africa (Siegfried et al., <xref ref-type="bibr" rid="B213">2009</xref>; Gebremedhin, <xref ref-type="bibr" rid="B84">2010</xref>; Wamai et al., <xref ref-type="bibr" rid="B248">2011</xref>) (Table <xref ref-type="table" rid="T5">5</xref>). However, the impact of MC for MSM is unknown (Smith et al., <xref ref-type="bibr" rid="B218">2010</xref>), as is the overall population of MSM in sub-Saharan Africa. It has been estimated that HIV transmission among MSM accounts for 0.6–16% of infections, depending on the country (Wamai et al., <xref ref-type="bibr" rid="B248">2011</xref>). Newer data suggest that MC among MSM in the US, where the overall prevalence of MC already ranges from 43 to 80%, would be of limited benefit (Gust et al., <xref ref-type="bibr" rid="B95">2010</xref>; Jozkowski et al., <xref ref-type="bibr" rid="B113">2010</xref>; Smith et al., <xref ref-type="bibr" rid="B218">2010</xref>; Wei et al., <xref ref-type="bibr" rid="B251">2011</xref>). A protective effect was seen in a subgroup of MSM reporting an insertive role, but overall, in 21 observational studies with 71,693 MSM participants, MC did not prevent HIV transmission (Wiysonge et al., <xref ref-type="bibr" rid="B258">2011</xref>), probably because it has no effect on transmission through receptive anal intercourse.</p><table-wrap id="T5" position="float"><label>Table 5</label><caption><p><bold>Selected clinical trials of male circumcision</bold>.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"><bold>Male circumcision</bold></th><th align="left" rowspan="1" colspan="1"><bold>Status</bold></th><th align="left" rowspan="1" colspan="1"><bold>Phase</bold></th><th align="left" rowspan="1" colspan="1"><bold>Target group</bold></th><th align="left" rowspan="1" colspan="1"><bold>Alternate study ID</bold></th><th align="left" rowspan="1" colspan="1"><bold>Observation</bold></th><th align="left" rowspan="1" colspan="1"><bold>References</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">NCT00124878</td><td align="left" rowspan="1" colspan="1">Unknown</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Men</td><td align="left" rowspan="1" colspan="1">22006</td><td align="left" rowspan="1" colspan="1">No reduction of HIV transmission to female partners</td><td align="left" rowspan="1" colspan="1">Wamai et al., <xref ref-type="bibr" rid="B248">2011</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00425984</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Men</td><td align="left" rowspan="1" colspan="1">U1AI171-1-02</td><td align="left" rowspan="1" colspan="1">55% efficacy</td><td align="left" rowspan="1" colspan="1">Gray et al., <xref ref-type="bibr" rid="B92">2007</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00122525</td><td align="left" rowspan="1" colspan="1">Terminated</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Men</td><td align="left" rowspan="1" colspan="1">ANRS 1265</td><td align="left" rowspan="1" colspan="1">60% efficacy</td><td align="left" rowspan="1" colspan="1">Auvert et al., <xref ref-type="bibr" rid="B15">2005</xref></td></tr></tbody></table><table-wrap-foot><p>More information about the individual trials can be found using the NCT number and the following databases: <ext-link ext-link-type="uri" xlink:href="http://www.aidsinfo.nih.gov/clinical-trials">www.aidsinfo.nih.gov/clinical-trials</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.avac.org">http://www.avac.org</ext-link>.</p></table-wrap-foot></table-wrap><p>Other alternatives for prevention or cure are targeting the CCR5 receptor as well as the latent HIV reservoir. With regard to the former, the idea of modulating the expression of CCR5 on CD4 T-cells is not new and CCR5 blocking molecules are used in the clinic (e.g., Maraviroc) or have been investigated in animal models or clinical trials (e.g., TAK-779, Aplaviroc, and Vicriviroc). However, resistance, lack of efficiency or toxicity has been associated with these compounds (Ryan, <xref ref-type="bibr" rid="B198">2005</xref>; Sax, <xref ref-type="bibr" rid="B202">2006</xref>; Nichols et al., <xref ref-type="bibr" rid="B160">2008</xref>; Ogert et al., <xref ref-type="bibr" rid="B164">2008</xref>; Demarest et al., <xref ref-type="bibr" rid="B56">2009</xref>; Kitrinos et al., <xref ref-type="bibr" rid="B120">2009</xref>; Wilkin et al., <xref ref-type="bibr" rid="B254">2010</xref>). For example, treatment with CCR5 co-receptor antagonists can lead to selection of resistant viruses whose entry rates into target cells in the presence of the antagonist have been restored to wild-type levels (Putcharoen et al., <xref ref-type="bibr" rid="B187">2011</xref>). Nevertheless, interest in targeting the CCR5 co-receptor persists, in part due to the case study of an individual potentially cured of HIV infection after receiving a bone marrow transplant for treatment of acute myeloid leukemia from a donor homozygous for CCR5Δ32 (Allers et al., <xref ref-type="bibr" rid="B7">2011</xref>). New approaches include attempts to permanently alter the expression of the CCR5 receptor on CD4 cells by gene therapy (e.g., knockout and knockdown) (Cannon and June, <xref ref-type="bibr" rid="B37">2011</xref>). shRNA knockdown of CCR5 in the humanized mouse model has led to reduced expression on T-cells in the gut mucosa, and splenocytes were harder to infect with HIV (Shimizu et al., <xref ref-type="bibr" rid="B212">2010</xref>). In another experiment, RNA interference-mediated knockdown of CCR5 was stable for 10 days and challenged animals exhibited reduced plasma viral loads and enhanced resistance to infection (Kim et al., <xref ref-type="bibr" rid="B118">2010</xref>). Nevertheless, all interventions have drawbacks. Disadvantages of CCR5 knockout include lower anti-tumor, anti-bacterial and anti-parasitic responses, as shown in animal model studies (Gonzalez-Martin et al., <xref ref-type="bibr" rid="B89">2011</xref>; Olive et al., <xref ref-type="bibr" rid="B168">2011</xref>; Sullivan et al., <xref ref-type="bibr" rid="B222">2011</xref>). In addition, disruptions of the normal control of other infectious diseases may occur. For example, in humans CCR5 deficiency is a risk factor for both early and late clinical manifestations of West Nile virus (Lim et al., <xref ref-type="bibr" rid="B136">2010</xref>) and tickborne encephalitis (Kindberg et al., <xref ref-type="bibr" rid="B119">2008</xref>) infections.</p><p>The idea of purging the viral reservoir in order to affect a cure of HIV infection has been a long-term goal (Frater, <xref ref-type="bibr" rid="B79">2011</xref>; Palmer et al., <xref ref-type="bibr" rid="B173">2011</xref>). However, simply intensifying drug regimens has not succeeded despite suppression of viral loads below 1 copy/ml plasma (Byakwaga et al., <xref ref-type="bibr" rid="B36">2011</xref>; Dahl et al., <xref ref-type="bibr" rid="B54">2011</xref>). A potential explanation could be on going cell to cell spread of the virus (Sigal et al., <xref ref-type="bibr" rid="B215">2011</xref>). In rare instances upon infection of resting CD4 T-cells HIV goes into latency, a phenomenon known for over 20 years (Bednarik and Folks, <xref ref-type="bibr" rid="B22">1992</xref>). These latent reservoir cells have a long half-life and reactivation leads to reemerging viremia (Iglesias-Ussel and Romerio, <xref ref-type="bibr" rid="B106">2011</xref>; Pace et al., <xref ref-type="bibr" rid="B171">2011</xref>). Mechanisms controlling latency act at the transcriptional level, where hypo-acetylation of histones correlates with repression (Lafeuillade and Stevenson, <xref ref-type="bibr" rid="B129">2011</xref>). Histone deacetylase (HDAC) inhibitors, such as Valproic acid (VPA), a known medication for psychiatric disorders, have been tried together with ART to reduce the latent virus reservoir with mixed results and side-effects at higher doses (Lehrman et al., <xref ref-type="bibr" rid="B132">2005</xref>; Margolis, <xref ref-type="bibr" rid="B143">2011</xref>; Matalon et al., <xref ref-type="bibr" rid="B146">2011</xref>; Routy et al., <xref ref-type="bibr" rid="B196">2012</xref>). The development of safer, more efficient HDAC inhibitors in combination with ART might provide a promising path toward a cure for HIV (Margolis, <xref ref-type="bibr" rid="B143">2011</xref>). Other more specific HDAC inhibitors are under development (Matalon et al., <xref ref-type="bibr" rid="B146">2011</xref>). A promising candidate is Givinostat, shown to be safe in humans, and slated to move into clinical phase II trials (Furlan et al., <xref ref-type="bibr" rid="B80">2011</xref>).</p></sec><sec><title>Vaccine development</title><p>HIV vaccines have been designed for both therapy and prevention. Multiple clinical trials with therapeutic vaccines have been conducted. To mention a few, approaches have included rAd5-HIV <italic>gag</italic> (Li et al., <xref ref-type="bibr" rid="B135">2011</xref>) Tat protein or Tat DNA (Caputo et al., <xref ref-type="bibr" rid="B38">2009</xref>), ALVAC encoding multiple HIV genes plus gp160 (Jin et al., <xref ref-type="bibr" rid="B111">2002</xref>), gp160 protein alone (Kundu-Raychaudhuri et al., <xref ref-type="bibr" rid="B126">2001</xref>; Gudmundsdotter et al., <xref ref-type="bibr" rid="B94">2008</xref>), and dendritic cells (DC) pulsed with autologous inactivated virus (García et al., <xref ref-type="bibr" rid="B82">2011</xref>). The overall outcome in most studies was a temporary significant drop in viral loads, induction of cytotoxic T-cell responses, as well as improved CD4 counts. To date, therapeutic vaccines have not progressed to the point of replacing drug therapy. However, this is an important although challenging goal in view of toxicities associated with drug regimens. A key factor in application of all therapeutic vaccines may be early initiation after infection in order to surmount HIV-associated T- and B-cell dysfunctions.</p><p>Most of the research emphasis in the field is devoted toward the development of a preventive HIV vaccine. A highly efficacious vaccine would circumvent the need for multiple preventive strategies, and would have its greatest impact in countries of the emerging and developing world where treatment availability is still scarce. However, such a vaccine is still elusive (Girard et al., <xref ref-type="bibr" rid="B86">2011</xref>). The clinical trial (RV144) of ALVAC-HIV recombinant priming followed by gp120 protein boosting (Table <xref ref-type="table" rid="T6">6</xref>) (Rerks-Ngarm et al., <xref ref-type="bibr" rid="B191">2009</xref>; Girard et al., <xref ref-type="bibr" rid="B86">2011</xref>) conducted in Thailand showed 31% efficacy. It has been suggested that in Thailand the RV-144 approach could provide modest long term benefit even without revaccination to combat the short-term effectiveness of the vaccine (Schneider et al., <xref ref-type="bibr" rid="B206">2011</xref>). However, the vaccine approach overall was far from reaching the protective efficacy desired. As outlined below, achieving a more efficacious vaccine will require continuing, major research efforts.</p><table-wrap id="T6" position="float"><label>Table 6</label><caption><p><bold>Selected clinical trials of HIV prophylactic vaccines</bold>.</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="1" colspan="1"><bold>Clinical trial identifier</bold></th><th align="left" rowspan="1" colspan="1"><bold>Status</bold></th><th align="left" rowspan="1" colspan="1"><bold>Phase</bold></th><th align="left" rowspan="1" colspan="1"><bold>Vaccine approach</bold></th><th align="left" rowspan="1" colspan="1"><bold>Alternative study ID</bold></th><th align="left" rowspan="1" colspan="1"><bold>Vaccine components</bold></th><th align="left" rowspan="1" colspan="1"><bold>Comment/references</bold></th></tr></thead><tbody><tr><td align="left" rowspan="1" colspan="1">NCT00002441</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Subunit priming and boosting</td><td align="left" rowspan="1" colspan="1">AIDSVAX B/B, VAX 004</td><td align="left" rowspan="1" colspan="1">MN rgp120/HIV-1 and GNE8 rgp120/HIV-1</td><td align="left" rowspan="1" colspan="1">No protection; Flynn et al., <xref ref-type="bibr" rid="B77">2005</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00006327</td><td align="left" rowspan="1" colspan="1">Complete</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Subunit priming and boosting</td><td align="left" rowspan="1" colspan="1">AIDSVAX B/E, VAX 003</td><td align="left" rowspan="1" colspan="1">MN rgp120/HIV-1 and A244 rgp120/HIV-1</td><td align="left" rowspan="1" colspan="1">No protection; Pitisuttithum et al., <xref ref-type="bibr" rid="B183">2006</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00223080</td><td align="left" rowspan="1" colspan="1">Active</td><td align="left" rowspan="1" colspan="1">III</td><td align="left" rowspan="1" colspan="1">Vector priming, subunit boosting</td><td align="left" rowspan="1" colspan="1">RV-144</td><td align="left" rowspan="1" colspan="1">ALVAC-HIV vCP1521 + AIDSVAX</td><td align="left" rowspan="1" colspan="1">31.2% efficacy; Rerks-Ngarm et al., <xref ref-type="bibr" rid="B191">2009</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00095576</td><td align="left" rowspan="1" colspan="1">Terminated</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">Vector priming and boosting</td><td align="left" rowspan="1" colspan="1">STEP study</td><td align="left" rowspan="1" colspan="1">Trivalent MRKAd5 HIV-1 gag/pol/nef</td><td align="left" rowspan="1" colspan="1">No protection; Buchbinder et al., <xref ref-type="bibr" rid="B34">2008</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00413725</td><td align="left" rowspan="1" colspan="1">Suspended</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">Vector priming and boosting</td><td align="left" rowspan="1" colspan="1">Phambili study</td><td align="left" rowspan="1" colspan="1">MRKAd5 HIV-1 gag/pol/nef</td><td align="left" rowspan="1" colspan="1">No protection; Gray et al., <xref ref-type="bibr" rid="B91">2011</xref></td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00865566</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">DNA priming, vector boosting</td><td align="left" rowspan="1" colspan="1">HVTN 505</td><td align="left" rowspan="1" colspan="1">VRC-HIVDNA016-00-VP (DNA) + VRC-HIVADV014-00-VP (rAd5)</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00820846</td><td align="left" rowspan="1" colspan="1">Active</td><td align="left" rowspan="1" colspan="1">II</td><td align="left" rowspan="1" colspan="1">DNA priming, vector boosting</td><td align="left" rowspan="1" colspan="1">HVTN 205</td><td align="left" rowspan="1" colspan="1">pGA2/JS7 DNA + MVA/HIV clade B gag-pol-env</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01418235</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">DNA/vector/subunit</td><td align="left" rowspan="1" colspan="1">HVTN 086/SAAVI 103</td><td align="left" rowspan="1" colspan="1">DNA-C2 + MVA-C + gp140 in MF59</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT00062530</td><td align="left" rowspan="1" colspan="1">Not yet recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">Recombinant bacteria</td><td align="left" rowspan="1" colspan="1">P01AI47490</td><td align="left" rowspan="1" colspan="1">Oral recombinant Salmonella typhi HIV-1 gp120</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01441193</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">Subunit priming and boosting</td><td align="left" rowspan="1" colspan="1">ISS P-002</td><td align="left" rowspan="1" colspan="1">HIV-1 Tat; delta-V2 Env</td><td align="left" rowspan="1" colspan="1">–</td></tr><tr><td align="left" rowspan="1" colspan="1">NCT01095224</td><td align="left" rowspan="1" colspan="1">Recruiting</td><td align="left" rowspan="1" colspan="1">I</td><td align="left" rowspan="1" colspan="1">Vector priming and boosting</td><td align="left" rowspan="1" colspan="1">HVTN 083</td><td align="left" rowspan="1" colspan="1">rAd35 Env A+rAd5 Env A or rAd5 Env B</td><td align="left" rowspan="1" colspan="1">–</td></tr></tbody></table><table-wrap-foot><p>More information about the individual trials can be found using the NCT number and the following databases: <ext-link ext-link-type="uri" xlink:href="http://www.aidsinfo.nih.gov/clinical-trials">www.aidsinfo.nih.gov/clinical-trials</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">www.clinicaltrials.gov</ext-link>; <ext-link ext-link-type="uri" xlink:href="http://www.avac.org">http://www.avac.org</ext-link>.</p></table-wrap-foot></table-wrap><p>An ideal vaccine should induce long lived memory T-cells with high cytotoxic potential and B-cells able to secrete potent, functional antibodies (Benmira et al., <xref ref-type="bibr" rid="B25">2010</xref>). As T-cell vaccines have been intensively reviewed recently (Ahlers and Belyakov, <xref ref-type="bibr" rid="B5">2010a</xref>,<xref ref-type="bibr" rid="B6">b</xref>; Perrin et al., <xref ref-type="bibr" rid="B179">2010</xref>), here we will address B cell immunity. That antibodies alone are sufficient to prevent infection has been clearly shown in passive transfer studies in animal models (Baba et al., <xref ref-type="bibr" rid="B16">2000</xref>; Mascola et al., <xref ref-type="bibr" rid="B145">2000</xref>; Nishimura et al., <xref ref-type="bibr" rid="B161">2003</xref>). Additionally, a recent gene therapy approach using an AAV vector expressing neutralizing antibody conferred protection in non-human primates (Johnson et al., <xref ref-type="bibr" rid="B112">2009</xref>). In addition to the well-known broadly neutralizing antibodies b12, 2G12, 2F5, 4E10, and Z13 (Muster et al., <xref ref-type="bibr" rid="B154">1993</xref>; Burton et al., <xref ref-type="bibr" rid="B35">1994</xref>; Trkola et al., <xref ref-type="bibr" rid="B230">1996</xref>; Zwick et al., <xref ref-type="bibr" rid="B267">2001</xref>) the recent isolation of even more potent broadly neutralizing antibodies from infected patients, including VRC-01, -02, and -03; PG9, PG16, 3BNC117, NIH45-46, PGT121-123, and PGT125-128 (Walker et al., <xref ref-type="bibr" rid="B247">2009</xref>, <xref ref-type="bibr" rid="B246">2011</xref>; Wu et al., <xref ref-type="bibr" rid="B259">2010</xref>; Scheid et al., <xref ref-type="bibr" rid="B203">2011</xref>), shows that the immune system is capable of producing these highly sought antibodies. However, no vaccine approach has been able to elicit them, due in part to the complex structure of the HIV (and SIV) envelope (Roux and Taylor, <xref ref-type="bibr" rid="B197">2007</xref>; Schief et al., <xref ref-type="bibr" rid="B204">2009</xref>; Harris et al., <xref ref-type="bibr" rid="B100">2011</xref>; White et al., <xref ref-type="bibr" rid="B253">2011</xref>). Additionally, the HIV envelope has shown poor binding to germline predecessors of broadly neutralizing antibodies, suggesting a mechanism by which HIV may evade immune responses (Xiao et al., <xref ref-type="bibr" rid="B261">2009</xref>; Chen et al., <xref ref-type="bibr" rid="B47">2012</xref>). In fact, although examination of VRC-01-like antibodies revealed a common pathway of maturation, extensive affinity maturation steps were required to attain broad reactivity (Zhou et al., <xref ref-type="bibr" rid="B264">2010</xref>; Scheid et al., <xref ref-type="bibr" rid="B203">2011</xref>; Wu et al., <xref ref-type="bibr" rid="B259a">2011</xref>). Overall, up to 30% of HIV infected individuals develop cross-reactive neutralizing antibodies approximately 3 years after seroconversion, suggesting that the antibodies need multiple rounds of somatic hypermutation and affinity maturation to achieve broad reactivity and that current recombinant envelope immunogens are unable to promote this process from precursor naïve B-cells (Euler et al., <xref ref-type="bibr" rid="B69">2012</xref>).</p><p>Reverse vaccinology and structure-based vaccine design approaches focused on known neutralizing antibody targeted envelope epitopes are attempting to develop vaccine immunogens able to elicit the desired neutralizing antibody potency and breadth (Pejchal and Wilson, <xref ref-type="bibr" rid="B178">2010</xref>; Walker and Burton, <xref ref-type="bibr" rid="B245">2010</xref>). One approach to achieve presentation of critical conformational epitopes is stabilization of the CD4-mediated conformational change in the envelope using a single-chain analogue of the HIV gp120-CD4 complex (DeVico et al., <xref ref-type="bibr" rid="B61">2007</xref>). Other approaches as reviewed in Kwong et al. (<xref ref-type="bibr" rid="B128">2011</xref>) and Walker and Burton (<xref ref-type="bibr" rid="B245">2010</xref>) include virus like particles, soluble trimers, stabilized envelope trimers with deletion of the gp41 transmembrane domain, conformational stabilization of the Env core protein, generation of envelope subdomains (e.g., the outer domain containing the CD4 attachment site), and employment of scaffolds based on informatics and epitope transplantation (e.g., adding the conserved β15 loop of the CD4 binding site to an unrelated structure to present the epitope in its natural configuration). Stable trimers are now available and maintain native conformation (Harris et al., <xref ref-type="bibr" rid="B100">2011</xref>; Lewis et al., <xref ref-type="bibr" rid="B134">2011</xref>; Sellhorn et al., <xref ref-type="bibr" rid="B209">2011</xref>). However, overall envelope glycosylation and the resulting glycan shield can still influence immunogenicity (Benjouad et al., <xref ref-type="bibr" rid="B24">1992</xref>; Kumar et al., <xref ref-type="bibr" rid="B127">2011</xref>) and remains a problem for vaccine development and design (Kwong et al., <xref ref-type="bibr" rid="B128">2011</xref>).</p><p>The variable loop regions (V1/V2 and V3) of the viral envelope have regained attention, due to their interaction with the gut-homing α4β7 receptor (Arthos et al., <xref ref-type="bibr" rid="B13">2008</xref>), role in viral transmission, binding to highly potent neutralizing antibodies (Doores and Burton, <xref ref-type="bibr" rid="B63">2010</xref>; Collins-Fairclough et al., <xref ref-type="bibr" rid="B52">2011</xref>; Pejchal et al., <xref ref-type="bibr" rid="B177">2011</xref>) and recent correlation with reduced risk of HIV infection in the RV144 trial (Zolla-Pazner et al., <xref ref-type="bibr" rid="B265">2011a</xref>). As a result, scaffolds that present V1-V2 in the appropriate native conformation are currently under study. However, during HIV infection, V1-V2 loop sequences expand and add glycosylation sites, which in turn could affect binding and neutralization by antibodies (Sagar et al., <xref ref-type="bibr" rid="B199">2006</xref>). The V3 loop, long-thought to elicit only type-specific antibodies, has some structurally conserved elements (Carrow et al., <xref ref-type="bibr" rid="B41">1991</xref>; Boudet et al., <xref ref-type="bibr" rid="B32">1992</xref>; Almond et al., <xref ref-type="bibr" rid="B8">2010</xref>; Jiang et al., <xref ref-type="bibr" rid="B110">2010</xref>), suggesting a potential for inducing broadly neutralizing antibodies. Recently, a V3 scaffold immunogen based on structure-guided design elicited cross-clade neutralizing antibodies in rabbits (Totrov et al., <xref ref-type="bibr" rid="B227">2010</xref>; Zolla-Pazner et al., <xref ref-type="bibr" rid="B266">2011b</xref>), raising hope that similar constructs would be equally effective in humans. Nevertheless, structural approaches and reverse engineering still face multiple obstacles and limitations from numerous extrinsic factors such as the host immunoglobulin gene repertoire and cellular regulatory mechanisms in the immunized host during antigen processing and antibody affinity maturation (Van Regenmortel, <xref ref-type="bibr" rid="B238">2011</xref>, <xref ref-type="bibr" rid="B239">2012</xref>). Additional limitations are imposed by discontinuous epitopes that are difficult to isolate in their native tertiary structure, and quaternary structure which introduces transient, conformational “neotopes” and masked “cryptotopes” which appear only in the context of the assembled virus particle (Van Regenmortel, <xref ref-type="bibr" rid="B238">2011</xref>, <xref ref-type="bibr" rid="B239">2012</xref>). Cross-reactivity or heterospecificity arising from weak antigen B-cell receptor interactions can also potentially lead to auto reactive antibodies as reported for 2F5 and 4E10 (Haynes et al., <xref ref-type="bibr" rid="B101">2005</xref>). Understanding the complex interactions between antigen presenting cells (APC) and B-cells at different mucosal sites or in lymph nodes is important for designing optimal vaccine approaches. The HIV envelope in particular is poorly immunogenic. It can suppress CD4 T-cell activation and proliferation (Fernando et al., <xref ref-type="bibr" rid="B71">2007</xref>) and can mediate T-cell apoptosis (Arthos et al., <xref ref-type="bibr" rid="B14">2002</xref>). Further, high affinity antibodies recognizing the CD4-binding site can skew MHC class II presentation by partially obstructing antigen processing, leading to decreased anti-gp120 T helper responses (Tuen et al., <xref ref-type="bibr" rid="B234">2005</xref>). It is crucial to find measures to boost the envelope's immunogenicity in order to elicit potent and durable anti-env responses. The contributions of cells of the innate immune system, such as NK, NKT, γδ T-cells, and DC are under extensive investigation (Bostik et al., <xref ref-type="bibr" rid="B31">2010</xref>; Palucka et al., <xref ref-type="bibr" rid="B174">2010</xref>; Agrati et al., <xref ref-type="bibr" rid="B4">2011</xref>; Altfeld et al., <xref ref-type="bibr" rid="B9">2011</xref>; Padte et al., <xref ref-type="bibr" rid="B172">2011</xref>; Ansari et al., <xref ref-type="bibr" rid="B12">2012</xref>). Cross-talk between the innate and adaptive immune systems is important in shaping adaptive B-cell responses (Cerutti et al., <xref ref-type="bibr" rid="B44">2011</xref>). Innate programming of protective immunity in general and programming of antibody (and T cell) responses by innate immune components have recently been reviewed (Pulendran and Ahmed, <xref ref-type="bibr" rid="B186">2011</xref>).</p><p>Apart from design of specific vaccine components and regimens, the route of administration can influence immune response elicitation, systemically and mucosally at genital/rectal sites (Demberg and Robert-Guroff, <xref ref-type="bibr" rid="B58">2009</xref>; Mestecky et al., <xref ref-type="bibr" rid="B149">2010</xref>). Vectored vaccines can be administered by a variety of routes and in addition to eliciting T cell responses also effectively induce humoral immunity. Prominent vectors currently in use are replication competent or defective Adenoviruses, Canarypox (ALVAC), and Vaccinia (NYVAC, MVA) (Franchini et al., <xref ref-type="bibr" rid="B78">2004</xref>; Gomez et al., <xref ref-type="bibr" rid="B88">2008</xref>; Patterson and Robert-Guroff, <xref ref-type="bibr" rid="B176">2008</xref>; Barouch, <xref ref-type="bibr" rid="B19">2010</xref>; Chen et al., <xref ref-type="bibr" rid="B46">2010</xref>; Rollier et al., <xref ref-type="bibr" rid="B193">2011</xref>; Weli and Tryland, <xref ref-type="bibr" rid="B252">2011</xref>). Adenoviruses, by targeting mucosal epithelium, induce mucosal as well as systemic immunity. In fact, replication-competent Adenovirus vectors display a broad biodistribution. Regardless of mucosal immunization route, they target and persist in macrophages and myeloid dendritic cells (Patterson et al., <xref ref-type="bibr" rid="B176a">2012</xref>) and elicit comparable immune responses systemically and mucosally (Xiao et al., <xref ref-type="bibr" rid="B260">2012</xref>). An interesting approach is the use of recombinant Cytomegalovirus (CMV) vectors. These recombinants also persist in the host and stimulate strong CD4 and CD8 cell responses (Hansen et al., <xref ref-type="bibr" rid="B99">2011</xref>). Using rhesus CMV vectors expressing SIV transgenes, strong protection from acquisition of SIV<sub>mac239</sub> was achieved in a rectal low-dose challenge model (Hansen et al., <xref ref-type="bibr" rid="B99">2011</xref>). In spite of the impressive protection in rhesus macaques, translation into the clinic may present a challenge due to the significant morbidity that can be caused by reoccurring CMV infection, seen for example, in immunosuppressed individuals (Sellar and Peggs, <xref ref-type="bibr" rid="B208">2012</xref>). Other vectors targeting the mucosa include integrase-defective lentiviruses (Negri et al., <xref ref-type="bibr" rid="B158">2011</xref>), noroviruses (Herbst-Kralovetz et al., <xref ref-type="bibr" rid="B102">2010</xref>) and engineered bacteria such as Listeria, Salmonella, Lactococcus, and Lactobacillus (Shahabi et al., <xref ref-type="bibr" rid="B210">2010</xref>; Bahey-El-Din and Gahan, <xref ref-type="bibr" rid="B17">2011</xref>; Lagenaur et al., <xref ref-type="bibr" rid="B130">2011</xref>).</p><p>DNA vaccines alone can also successfully prime and boost the immune system (Ferraro et al., <xref ref-type="bibr" rid="B73">2011</xref>; Sardesai and Weiner, <xref ref-type="bibr" rid="B201">2011</xref>) and together with viral vectors have induced lasting immune responses and long-term control of virus infection following challenge of non-human primates (Patel et al., <xref ref-type="bibr" rid="B175">2010</xref>; Lai et al., <xref ref-type="bibr" rid="B131">2011</xref>; Manrique et al., <xref ref-type="bibr" rid="B142">2011</xref>; Winstone et al., <xref ref-type="bibr" rid="B256">2011</xref>). Electroporation, instead of intramuscular injection of DNA, has enhanced development of durable immunity (Patel et al., <xref ref-type="bibr" rid="B175">2010</xref>). Moreover, use of DNA vaccines facilitates incorporation of cytokine immune modulators (IL-15, IL-12, GM-CSF, and TNF-α) into the vaccine strategy (Demberg et al., <xref ref-type="bibr" rid="B57">2008</xref>; Ferraro et al., <xref ref-type="bibr" rid="B73">2011</xref>; Lai et al., <xref ref-type="bibr" rid="B131">2011</xref>; Manrique et al., <xref ref-type="bibr" rid="B142">2011</xref>; Winstone et al., <xref ref-type="bibr" rid="B256">2011</xref>).</p><p>Vectored vaccines are often combined with envelope protein boosts, requiring an adjuvant. Cytokines and TLR ligands can serve this purpose (Berzofsky et al., <xref ref-type="bibr" rid="B26">2001</xref>; Tovey and Lallemand, <xref ref-type="bibr" rid="B228">2010</xref>; Bode et al., <xref ref-type="bibr" rid="B29">2011</xref>; Duthie et al., <xref ref-type="bibr" rid="B64">2011</xref>) but traditionally, adjuvants function as depots while also acting as immunostimulants (Reed et al., <xref ref-type="bibr" rid="B189">2009</xref>; Carter and Reed, <xref ref-type="bibr" rid="B42">2010</xref>). Currently there are only two adjuvants in licensed vaccines available in the USA: aluminum salts, including aluminum hydroxide, aluminum phosphate and alum (potassium aluminum sulfate); and AS04 (aluminum hydroxide combined with monophosphoryl lipid (<ext-link ext-link-type="uri" xlink:href="http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm">http://www.fda.gov/BiologicsBloodVaccines/Safety Availability/VaccineSafety/ucm187810.htm</ext-link>). In Europe, additional approved adjuvants include MF59 (squalene-based oil in water emulsion) and AS03 (also squalene-based) (Tritto et al., <xref ref-type="bibr" rid="B229">2009</xref>; Carter and Reed, <xref ref-type="bibr" rid="B42">2010</xref>; O'Hagan et al., <xref ref-type="bibr" rid="B165">2011</xref>). Yet additional adjuvants are needed. Broad new candidates include carbohydrate-based and saponin based compounds, ISCOM Matrix, cationic liposomes, and Nano-microparticles (Oyewumi et al., <xref ref-type="bibr" rid="B170">2010</xref>; Christensen et al., <xref ref-type="bibr" rid="B50">2011</xref>; Lovgren Bengtsson et al., <xref ref-type="bibr" rid="B139">2011</xref>; Petrovsky and Cooper, <xref ref-type="bibr" rid="B180">2011</xref>; Ragupathi et al., <xref ref-type="bibr" rid="B188">2011</xref>; Schijns and Lavelle, <xref ref-type="bibr" rid="B205">2011</xref>).</p><p>A crucial aspect for the evaluation of candidate vaccines is availability of relevant animal models. Currently there are only two appropriate models: non-human primates and the newly developed bone marrow/liver/thymus (BLT) mouse model. The BLT mouse develops human T cells and B cells, monocyte/macrophages and DC (Wege et al., <xref ref-type="bibr" rid="B250">2008</xref>). In this model HIV latency has been described and thus the BLT mouse is suitable for testing drug regimens, including evaluation of HDAC inhibitors (Marsden et al., <xref ref-type="bibr" rid="B144">2011</xref>). Due to the reconstitution of the female BLT mouse reproductive tract with human immune cells, vaginal challenges can be performed and microbicides can be evaluated (Denton et al., <xref ref-type="bibr" rid="B59">2011</xref>; Olesen et al., <xref ref-type="bibr" rid="B167">2011</xref>). In addition, candidate vaccines based on non-replicating vectors as well as novel adjuvants can be tested in a shorter time frame and at lower cost compared to non-human primate models (Biswas et al., <xref ref-type="bibr" rid="B28">2011</xref>). However, the BLT mouse model has its limitations, including lack of proper T-cell help which affects development of humoral responses (Biswas et al., <xref ref-type="bibr" rid="B28">2011</xref>).</p><p>Overall non-human primates provide the best, although not perfect, model for evaluation of pre-clinical candidate vaccines (Morgan et al., <xref ref-type="bibr" rid="B152">2008</xref>; Rompay, <xref ref-type="bibr" rid="B194">2011</xref>). The SIV rhesus macaque system appropriately models HIV disease of humans with regard to mode of transmission, viremia levels, depletion of CD4 cells, and development of AIDS. However, the difference in the SIV and HIV envelopes does not allow evaluation of anti-HIV envelope immunity in the SIV system. The SHIV model while not as robust, allows evaluation of vaccines targeting the HIV envelope and their ability to elicit sterilizing immunity, however, it is generally poorly pathogenic and overall a poor model of HIV biology and disease progression in humans. Further, experiments in non-human primates are expensive, and the number of macaques required for a pre-clinical vaccine study has increased with the use of low-dose repeated challenge experiments that better mimic the HIV infection of people (Keele et al., <xref ref-type="bibr" rid="B115">2009</xref>). Thus, evaluation of a single vaccine candidate and a control could require 50 macaques (Hudgens and Gilbert, <xref ref-type="bibr" rid="B105">2009</xref>), However, it could be designed and completed quickly. The cost for such a macaque study is far surpassed by that of a human clinical trial. As summarized by Shedlock et al. (<xref ref-type="bibr" rid="B211">2009</xref>), the non-human primate model has a key role to play in evaluating vaccine candidates for the ability to induce improved immune responses, in testing hypothesis driven research, in providing proof of concept, and in identifying new immune targets for incorporation into vaccine design. In that way the model helps select vaccine candidates for advancement into the limited number of possible clinical trials.</p></sec><sec><title>Summary and conclusion</title><p>As briefly summarized by this review the substantial progress made in AIDS treatment has stimulated the concept of “treatment as prevention.” Additionally, vaccine development has picked up momentum due to new discoveries and the modest success of the RV144 clinical trial in Thailand. However, to achieve global control of HIV/AIDS infection in the absence of a highly efficacious vaccine or cure, a combination of multiple preventive measures will need to be continuously applied. Further investigation of all elements of the host immune system, both innate and adaptive, as well as development of novel treatment strategies should proceed in order to insure strong control of the AIDS pandemic and eventual eradication of the disease.</p><sec><title>Conflict of interest statement</title><p>The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.</p></sec></sec></body><back><ack><p>We thank L. Jean Patterson and Janet DiPasquale for critical comments and reading of the manuscript. 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