Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study.
Identifieur interne : 001196 ( Main/Exploration ); précédent : 001195; suivant : 001197Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study.
Auteurs : Rodger D. Macarthur [États-Unis] ; Trevor N. Hawkins [États-Unis] ; Stephen J. Brown [États-Unis] ; Anthony Lamarca [États-Unis] ; Patrick G. Clay [États-Unis] ; Andrew C. Barrett [États-Unis] ; Enoch Bortey [États-Unis] ; Craig Paterson [États-Unis] ; Pamela L. Golden [États-Unis] ; William P. Forbes [États-Unis]Source :
- HIV clinical trials [ 1528-4336 ]
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Agents gastro-intestinaux (effets indésirables), Agents gastro-intestinaux (usage thérapeutique), Canaux chlorure (antagonistes et inhibiteurs), Diarrhée (traitement médicamenteux), Diarrhée (étiologie), Femelle (MeSH), Humains (MeSH), Infections à VIH (complications), Mâle (MeSH), Méthode en double aveugle (MeSH), Proanthocyanidines (effets indésirables), Proanthocyanidines (usage thérapeutique).
- MESH :
- antagonistes et inhibiteurs : Canaux chlorure.
- effets indésirables : Agents gastro-intestinaux, Infections à VIH, Proanthocyanidines.
- traitement médicamenteux : Diarrhée.
- usage thérapeutique : Agents gastro-intestinaux, Proanthocyanidines.
- étiologie : Diarrhée.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Mâle, Méthode en double aveugle.
English descriptors
- KwdEn :
- Adult (MeSH), Chloride Channels (antagonists & inhibitors), Diarrhea (drug therapy), Diarrhea (etiology), Double-Blind Method (MeSH), Female (MeSH), Gastrointestinal Agents (adverse effects), Gastrointestinal Agents (therapeutic use), HIV Infections (complications), Humans (MeSH), Male (MeSH), Middle Aged (MeSH), Proanthocyanidins (adverse effects), Proanthocyanidins (therapeutic use).
- MESH :
- chemical , adverse effects : Gastrointestinal Agents, Proanthocyanidins.
- chemical , antagonists & inhibitors : Chloride Channels.
- complications : HIV Infections.
- drug therapy : Diarrhea.
- etiology : Diarrhea.
- chemical , therapeutic use : Gastrointestinal Agents, Proanthocyanidins.
- Adult, Double-Blind Method, Female, Humans, Male, Middle Aged.
Abstract
BACKGROUND
HIV-associated diarrhea remains a significant concern with limited treatment options.
OBJECTIVE
To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea.
METHODS
This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly.
RESULTS
Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo.
CONCLUSIONS
In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.
DOI: 10.1310/hct1406-261
PubMed: 24334179
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study.</title><author><name sortKey="Macarthur, Rodger D" sort="Macarthur, Rodger D" uniqKey="Macarthur R" first="Rodger D" last="Macarthur">Rodger D. Macarthur</name><affiliation wicri:level="2"><nlm:affiliation>Division of Infectious Diseases, Wayne State University, Detroit, Michigan.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Division of Infectious Diseases, Wayne State University, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Hawkins, Trevor N" sort="Hawkins, Trevor N" uniqKey="Hawkins T" first="Trevor N" last="Hawkins">Trevor N. Hawkins</name><affiliation wicri:level="2"><nlm:affiliation>Southwest CARE, Santa Fe, New Mexico.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Nouveau-Mexique</region></placeName><wicri:cityArea>Southwest CARE, Santa Fe</wicri:cityArea></affiliation></author><author><name sortKey="Brown, Stephen J" sort="Brown, Stephen J" uniqKey="Brown S" first="Stephen J" last="Brown">Stephen J. Brown</name><affiliation wicri:level="2"><nlm:affiliation>AIDS Research Alliance, Los Angeles, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>AIDS Research Alliance, Los Angeles</wicri:cityArea></affiliation></author><author><name sortKey="Lamarca, Anthony" sort="Lamarca, Anthony" uniqKey="Lamarca A" first="Anthony" last="Lamarca">Anthony Lamarca</name><affiliation wicri:level="2"><nlm:affiliation>Therafirst Medical Center, Fort Lauderdale, Florida.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Therafirst Medical Center, Fort Lauderdale</wicri:cityArea></affiliation></author><author><name sortKey="Clay, Patrick G" sort="Clay, Patrick G" uniqKey="Clay P" first="Patrick G" last="Clay">Patrick G. Clay</name><affiliation wicri:level="2"><nlm:affiliation>University of North Texas System College of Pharmacy, Fort Worth, Texas.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>University of North Texas System College of Pharmacy, Fort Worth</wicri:cityArea></affiliation></author><author><name sortKey="Barrett, Andrew C" sort="Barrett, Andrew C" uniqKey="Barrett A" first="Andrew C" last="Barrett">Andrew C. Barrett</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Paterson, Craig" sort="Paterson, Craig" uniqKey="Paterson C" first="Craig" last="Paterson">Craig Paterson</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Golden, Pamela L" sort="Golden, Pamela L" uniqKey="Golden P" first="Pamela L" last="Golden">Pamela L. Golden</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2013">2013 Nov-Dec</date><idno type="RBID">pubmed:24334179</idno><idno type="pmid">24334179</idno><idno type="doi">10.1310/hct1406-261</idno><idno type="wicri:Area/Main/Corpus">001180</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001180</idno><idno type="wicri:Area/Main/Curation">001180</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">001180</idno><idno type="wicri:Area/Main/Exploration">001180</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study.</title><author><name sortKey="Macarthur, Rodger D" sort="Macarthur, Rodger D" uniqKey="Macarthur R" first="Rodger D" last="Macarthur">Rodger D. Macarthur</name><affiliation wicri:level="2"><nlm:affiliation>Division of Infectious Diseases, Wayne State University, Detroit, Michigan.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Michigan</region></placeName><wicri:cityArea>Division of Infectious Diseases, Wayne State University, Detroit</wicri:cityArea></affiliation></author><author><name sortKey="Hawkins, Trevor N" sort="Hawkins, Trevor N" uniqKey="Hawkins T" first="Trevor N" last="Hawkins">Trevor N. Hawkins</name><affiliation wicri:level="2"><nlm:affiliation>Southwest CARE, Santa Fe, New Mexico.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Nouveau-Mexique</region></placeName><wicri:cityArea>Southwest CARE, Santa Fe</wicri:cityArea></affiliation></author><author><name sortKey="Brown, Stephen J" sort="Brown, Stephen J" uniqKey="Brown S" first="Stephen J" last="Brown">Stephen J. Brown</name><affiliation wicri:level="2"><nlm:affiliation>AIDS Research Alliance, Los Angeles, California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>AIDS Research Alliance, Los Angeles</wicri:cityArea></affiliation></author><author><name sortKey="Lamarca, Anthony" sort="Lamarca, Anthony" uniqKey="Lamarca A" first="Anthony" last="Lamarca">Anthony Lamarca</name><affiliation wicri:level="2"><nlm:affiliation>Therafirst Medical Center, Fort Lauderdale, Florida.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Therafirst Medical Center, Fort Lauderdale</wicri:cityArea></affiliation></author><author><name sortKey="Clay, Patrick G" sort="Clay, Patrick G" uniqKey="Clay P" first="Patrick G" last="Clay">Patrick G. Clay</name><affiliation wicri:level="2"><nlm:affiliation>University of North Texas System College of Pharmacy, Fort Worth, Texas.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>University of North Texas System College of Pharmacy, Fort Worth</wicri:cityArea></affiliation></author><author><name sortKey="Barrett, Andrew C" sort="Barrett, Andrew C" uniqKey="Barrett A" first="Andrew C" last="Barrett">Andrew C. Barrett</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Paterson, Craig" sort="Paterson, Craig" uniqKey="Paterson C" first="Craig" last="Paterson">Craig Paterson</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Golden, Pamela L" sort="Golden, Pamela L" uniqKey="Golden P" first="Pamela L" last="Golden">Pamela L. Golden</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author><author><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name><affiliation wicri:level="2"><nlm:affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Caroline du Nord</region></placeName><wicri:cityArea>Salix Pharmaceuticals, Inc, Raleigh</wicri:cityArea></affiliation></author></analytic><series><title level="j">HIV clinical trials</title><idno type="ISSN">1528-4336</idno></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Chloride Channels (antagonists & inhibitors)</term><term>Diarrhea (drug therapy)</term><term>Diarrhea (etiology)</term><term>Double-Blind Method (MeSH)</term><term>Female (MeSH)</term><term>Gastrointestinal Agents (adverse effects)</term><term>Gastrointestinal Agents (therapeutic use)</term><term>HIV Infections (complications)</term><term>Humans (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Proanthocyanidins (adverse effects)</term><term>Proanthocyanidins (therapeutic use)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Agents gastro-intestinaux (effets indésirables)</term><term>Agents gastro-intestinaux (usage thérapeutique)</term><term>Canaux chlorure (antagonistes et inhibiteurs)</term><term>Diarrhée (traitement médicamenteux)</term><term>Diarrhée (étiologie)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Infections à VIH (complications)</term><term>Mâle (MeSH)</term><term>Méthode en double aveugle (MeSH)</term><term>Proanthocyanidines (effets indésirables)</term><term>Proanthocyanidines (usage thérapeutique)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Gastrointestinal Agents</term><term>Proanthocyanidins</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Chloride Channels</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Canaux chlorure</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>HIV Infections</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Diarrhea</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Agents gastro-intestinaux</term><term>Infections à VIH</term><term>Proanthocyanidines</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Diarrhea</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Gastrointestinal Agents</term><term>Proanthocyanidins</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Diarrhée</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Agents gastro-intestinaux</term><term>Proanthocyanidines</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Diarrhée</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>HIV-associated diarrhea remains a significant concern with limited treatment options.</p></div><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24334179</PMID><DateCompleted><Year>2014</Year><Month>01</Month><Day>30</Day></DateCompleted><DateRevised><Year>2016</Year><Month>11</Month><Day>28</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">1528-4336</ISSN><JournalIssue CitedMedium="Print"><Volume>14</Volume><Issue>6</Issue><PubDate><MedlineDate>2013 Nov-Dec</MedlineDate></PubDate></JournalIssue><Title>HIV clinical trials</Title><ISOAbbreviation>HIV Clin Trials</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study.</ArticleTitle><Pagination><MedlinePgn>261-73</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1310/hct1406-261</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">HIV-associated diarrhea remains a significant concern with limited treatment options.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Macarthur</LastName><ForeName>Rodger D</ForeName><Initials>RD</Initials><AffiliationInfo><Affiliation>Division of Infectious Diseases, Wayne State University, Detroit, Michigan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hawkins</LastName><ForeName>Trevor N</ForeName><Initials>TN</Initials><AffiliationInfo><Affiliation>Southwest CARE, Santa Fe, New Mexico.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Stephen J</ForeName><Initials>SJ</Initials><AffiliationInfo><Affiliation>AIDS Research Alliance, Los Angeles, California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lamarca</LastName><ForeName>Anthony</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Therafirst Medical Center, Fort Lauderdale, Florida.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clay</LastName><ForeName>Patrick G</ForeName><Initials>PG</Initials><AffiliationInfo><Affiliation>University of North Texas System College of Pharmacy, Fort Worth, Texas.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barrett</LastName><ForeName>Andrew C</ForeName><Initials>AC</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bortey</LastName><ForeName>Enoch</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paterson</LastName><ForeName>Craig</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Golden</LastName><ForeName>Pamela L</ForeName><Initials>PL</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Forbes</LastName><ForeName>William P</ForeName><Initials>WP</Initials><AffiliationInfo><Affiliation>Salix Pharmaceuticals, Inc, Raleigh, North Carolina.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>HIV Clin Trials</MedlineTA><NlmUniqueID>100936377</NlmUniqueID><ISSNLinking>1528-4336</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018118">Chloride Channels</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005765">Gastrointestinal Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D044945">Proanthocyanidins</NameOfSubstance></Chemical><Chemical><RegistryNumber>PY79D6C8RX</RegistryNumber><NameOfSubstance UI="C546704">crofelemer</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018118" MajorTopicYN="N">Chloride Channels</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003967" MajorTopicYN="N">Diarrhea</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000209" MajorTopicYN="N">etiology</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="D005765" MajorTopicYN="N">Gastrointestinal Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015658" MajorTopicYN="N">HIV Infections</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="Y">complications</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D044945" MajorTopicYN="N">Proanthocyanidins</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">HIV</Keyword><Keyword MajorTopicYN="N">antidiarrheals</Keyword><Keyword MajorTopicYN="N">antiretroviral agents</Keyword><Keyword MajorTopicYN="N">chloride channels</Keyword><Keyword MajorTopicYN="N">diarrhea</Keyword><Keyword MajorTopicYN="N">drug toxicity</Keyword><Keyword MajorTopicYN="N">proanthocyanidins</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2013</Year><Month>12</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2013</Year><Month>12</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>1</Month><Day>31</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24334179</ArticleId><ArticleId IdType="pii">J232467V48732M45</ArticleId><ArticleId IdType="doi">10.1310/hct1406-261</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Californie</li><li>Caroline du Nord</li><li>Floride</li><li>Michigan</li><li>Nouveau-Mexique</li><li>Texas</li></region></list><tree><country name="États-Unis"><region name="Michigan"><name sortKey="Macarthur, Rodger D" sort="Macarthur, Rodger D" uniqKey="Macarthur R" first="Rodger D" last="Macarthur">Rodger D. Macarthur</name></region><name sortKey="Barrett, Andrew C" sort="Barrett, Andrew C" uniqKey="Barrett A" first="Andrew C" last="Barrett">Andrew C. Barrett</name><name sortKey="Bortey, Enoch" sort="Bortey, Enoch" uniqKey="Bortey E" first="Enoch" last="Bortey">Enoch Bortey</name><name sortKey="Brown, Stephen J" sort="Brown, Stephen J" uniqKey="Brown S" first="Stephen J" last="Brown">Stephen J. Brown</name><name sortKey="Clay, Patrick G" sort="Clay, Patrick G" uniqKey="Clay P" first="Patrick G" last="Clay">Patrick G. Clay</name><name sortKey="Forbes, William P" sort="Forbes, William P" uniqKey="Forbes W" first="William P" last="Forbes">William P. Forbes</name><name sortKey="Golden, Pamela L" sort="Golden, Pamela L" uniqKey="Golden P" first="Pamela L" last="Golden">Pamela L. Golden</name><name sortKey="Hawkins, Trevor N" sort="Hawkins, Trevor N" uniqKey="Hawkins T" first="Trevor N" last="Hawkins">Trevor N. Hawkins</name><name sortKey="Lamarca, Anthony" sort="Lamarca, Anthony" uniqKey="Lamarca A" first="Anthony" last="Lamarca">Anthony Lamarca</name><name sortKey="Paterson, Craig" sort="Paterson, Craig" uniqKey="Paterson C" first="Craig" last="Paterson">Craig Paterson</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Bois/explor/WillowV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001196 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 001196 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Bois
|area= WillowV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= pubmed:24334179
|texte= Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:24334179" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a WillowV1
| This area was generated with Dilib version V0.6.37. |  |