SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.
Identifieur interne : 000606 ( PubMed/Checkpoint ); précédent : 000605; suivant : 000607SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.
Auteurs : Leigh Peterson [États-Unis] ; Kavita Nanda ; Baafuor Kofi Opoku ; William Kwabena Ampofo ; Margaret Owusu-Amoako ; Andrew Yiadom Boakye ; Wes Rountree ; Amanda Troxler ; Rosalie Dominik ; Ronald Roddy ; Laneta DorflingerSource :
- PloS one [ 1932-6203 ] ; 2007.
Descripteurs français
- KwdFr :
- MESH :
- administration et posologie : Agents antiVIH.
- effets indésirables : Agents antiVIH.
- usage thérapeutique : Agents antiVIH, Infections à VIH.
- Administration par voie topique, Adulte, Femelle, Gels, Ghana, Humains, Infections à VIH, Mâle, Méthode en double aveugle, Placebo.
- Wicri :
- geographic : Ghana.
English descriptors
- KwdEn :
- MESH :
- chemical , administration & dosage : Anti-HIV Agents.
- chemical , adverse effects : Anti-HIV Agents.
- chemical , therapeutic use : Anti-HIV Agents.
- geographic : Ghana, Placebos.
- prevention & control : HIV Infections.
- transmission : HIV Infections.
- Administration, Topical, Adult, Double-Blind Method, Female, Gels, Humans, Male.
Abstract
The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.
DOI: 10.1371/journal.pone.0001312
PubMed: 18091987
Affiliations:
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Links to Exploration step
pubmed:18091987Le document en format XML
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xml:lang="fr"><term>Ghana</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">18091987</PMID><DateCreated><Year>2007</Year><Month>12</Month><Day>19</Day></DateCreated><DateCompleted><Year>2008</Year><Month>08</Month><Day>08</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1932-6203</ISSN><JournalIssue CitedMedium="Internet"><Volume>2</Volume><Issue>12</Issue><PubDate><Year>2007</Year><Month>Dec</Month><Day>19</Day></PubDate></JournalIssue><Title>PloS one</Title><ISOAbbreviation>PLoS ONE</ISOAbbreviation></Journal><ArticleTitle>SAVVY (C31G) gel for prevention of HIV infection in women: a Phase 3, double-blind, randomized, placebo-controlled trial in Ghana.</ArticleTitle><Pagination><MedlinePgn>e1312</MedlinePgn></Pagination><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.</AbstractText><AbstractText Label="METHODOLOGY/PRINCIPAL FINDINGS" NlmCategory="RESULTS">This was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between March 2004 and February 2006 in Accra and Kumasi, Ghana. We enrolled 2142 HIV-negative women at high risk of HIV infection, and randomized them to SAVVY or placebo gel. Main outcome measures were the incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate specimens and adverse events. We accrued 790 person-years of follow-up in the SAVVY group and 772 person-years in the placebo group. No clinically significant differences in the overall frequency of adverse events, abnormal pelvic examination findings, or abnormal laboratory results were seen between treatment groups. However, more participants in the SAVVY group reported reproductive tract adverse events than in the placebo group (13.0% versus 9.4%). Seventeen HIV seroconversions occurred; eight in participants randomized to SAVVY and nine in participants receiving placebo. The Kaplan-Meier estimates of the cumulative probability of HIV infection through 12 months were 0.010 in the SAVVY group and 0.011 in the placebo group (p = 0.731), with a hazard ratio (SAVVY versus placebo) of 0.88 (95% confidence interval 0.33, 2.27). Because of a lower-than-expected HIV incidence, we were unable to achieve the required number of HIV infections (66) to obtain the desired study power.</AbstractText><AbstractText Label="CONCLUSIONS/SIGNIFICANCE" NlmCategory="CONCLUSIONS">SAVVY was not associated with increased adverse events overall, but was associated with higher reporting of reproductive adverse events. Our data are insufficient to conclude whether SAVVY is effective at preventing HIV infection relative to placebo.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov NCT00129532.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Peterson</LastName><ForeName>Leigh</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Family Health International, Durham, North Carolina, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nanda</LastName><ForeName>Kavita</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Opoku</LastName><ForeName>Baafuor Kofi</ForeName><Initials>BK</Initials></Author><Author ValidYN="Y"><LastName>Ampofo</LastName><ForeName>William Kwabena</ForeName><Initials>WK</Initials></Author><Author ValidYN="Y"><LastName>Owusu-Amoako</LastName><ForeName>Margaret</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Boakye</LastName><ForeName>Andrew Yiadom</ForeName><Initials>AY</Initials></Author><Author ValidYN="Y"><LastName>Rountree</LastName><ForeName>Wes</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Troxler</LastName><ForeName>Amanda</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Dominik</LastName><ForeName>Rosalie</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Roddy</LastName><ForeName>Ronald</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Dorflinger</LastName><ForeName>Laneta</ForeName><Initials>L</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00129532</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013486">Research Support, U.S. Gov't, Non-P.H.S.</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2007</Year><Month>12</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>PLoS One</MedlineTA><NlmUniqueID>101285081</NlmUniqueID><ISSNLinking>1932-6203</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D019380">Anti-HIV Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005782">Gels</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D010919">Placebos</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Antimicrob Agents Chemother. 2000 Jul;44(7):1954-60</RefSource><PMID Version="1">10858360</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2001 Apr 14;357(9263):1191-4</RefSource><PMID Version="1">11323066</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2002 Sep 28;360(9338):971-7</RefSource><PMID Version="1">12383665</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contraception. 2002 Nov;66(5):365-8</RefSource><PMID Version="1">12443968</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contraception. 2004 Sep;70(3):221-5</RefSource><PMID Version="1">15325891</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Lancet. 2007 Mar 3;369(9563):787-97</RefSource><PMID Version="1">17336656</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contraception. 2004 Sep;70(3):233-40</RefSource><PMID Version="1">15325893</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Sex Transm Dis. 1991 Jul-Sep;18(3):176-9</RefSource><PMID Version="1">1658953</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Int J STD AIDS. 1993 May-Jun;4(3):165-70</RefSource><PMID Version="1">8391856</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contraception. 2005 Dec;72(6):408-13</RefSource><PMID Version="1">16307961</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Contraception. 2004 Sep;70(3):227-31</RefSource><PMID Version="1">15325892</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000287" MajorTopicYN="N">Administration, Topical</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019380" MajorTopicYN="N">Anti-HIV Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005782" MajorTopicYN="N">Gels</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005869" MajorTopicYN="N" Type="Geographic">Ghana</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015658" MajorTopicYN="N">HIV Infections</DescriptorName><QualifierName UI="Q000517" MajorTopicYN="Y">prevention & control</QualifierName><QualifierName UI="Q000635" MajorTopicYN="N">transmission</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010919" MajorTopicYN="N">Placebos</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC2129116</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2007</Year><Month>09</Month><Day>05</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2007</Year><Month>09</Month><Day>06</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2007</Year><Month>12</Month><Day>20</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2008</Year><Month>8</Month><Day>9</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2007</Year><Month>12</Month><Day>20</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">18091987</ArticleId><ArticleId IdType="doi">10.1371/journal.pone.0001312</ArticleId><ArticleId IdType="pmc">PMC2129116</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Caroline du Nord</li></region></list><tree><noCountry><name sortKey="Ampofo, William Kwabena" sort="Ampofo, William Kwabena" uniqKey="Ampofo W" first="William Kwabena" last="Ampofo">William Kwabena Ampofo</name><name sortKey="Boakye, Andrew Yiadom" sort="Boakye, Andrew Yiadom" uniqKey="Boakye A" first="Andrew Yiadom" last="Boakye">Andrew Yiadom Boakye</name><name sortKey="Dominik, Rosalie" sort="Dominik, Rosalie" uniqKey="Dominik R" first="Rosalie" last="Dominik">Rosalie Dominik</name><name sortKey="Dorflinger, Laneta" sort="Dorflinger, Laneta" uniqKey="Dorflinger L" first="Laneta" last="Dorflinger">Laneta Dorflinger</name><name sortKey="Nanda, Kavita" sort="Nanda, Kavita" uniqKey="Nanda K" first="Kavita" last="Nanda">Kavita Nanda</name><name sortKey="Opoku, Baafuor Kofi" sort="Opoku, Baafuor Kofi" uniqKey="Opoku B" first="Baafuor Kofi" last="Opoku">Baafuor Kofi Opoku</name><name sortKey="Owusu Amoako, Margaret" sort="Owusu Amoako, Margaret" uniqKey="Owusu Amoako M" first="Margaret" last="Owusu-Amoako">Margaret Owusu-Amoako</name><name sortKey="Roddy, Ronald" sort="Roddy, Ronald" uniqKey="Roddy R" first="Ronald" last="Roddy">Ronald Roddy</name><name sortKey="Rountree, Wes" sort="Rountree, Wes" uniqKey="Rountree W" first="Wes" last="Rountree">Wes Rountree</name><name sortKey="Troxler, Amanda" sort="Troxler, Amanda" uniqKey="Troxler A" first="Amanda" last="Troxler">Amanda Troxler</name></noCountry><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Peterson, Leigh" sort="Peterson, Leigh" uniqKey="Peterson L" first="Leigh" last="Peterson">Leigh Peterson</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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