A Randomized, Placebo-Controlled Trial of Rosiglitazone for HIV-Related Lipoatrophy
Identifieur interne : 003842 ( Main/Exploration ); précédent : 003841; suivant : 003843A Randomized, Placebo-Controlled Trial of Rosiglitazone for HIV-Related Lipoatrophy
Auteurs : Rodrigo B. Cavalcanti [Canada] ; Janet Raboud [Canada] ; Sandy Shen [Canada] ; Kevin C. Kain [Canada] ; Angela Cheung [Canada] ; Sharon Walmsley [Canada]Source :
- The Journal of Infectious Diseases [ 0022-1899 ] ; 2007.
Abstract
Background. Thiazolidinediones such as rosiglitazone may have benefit in ameliorating human immunodeficiency virus (HIV) lipoatrophy. Methods. HIV-positive patients receiving stable, protease inhibitor—containing highly active antiretroviral therapy with HIV lipodystrophy were prospectively randomized to rosiglitazone (4 mg/day) or placebo. The primary end point was the 24-week percentage change in arm fat by dual-energy x-ray absorptiometry (DEXA). Clinical and anthropometric evaluations, fasting lipid parameters, oral glucose tolerance testing, CD36 expression, quality of life measures, and DEXA scanning were performed at baseline and week 24. Results. Seventy-eight of the 96 enrolled patients were evaluated. Median age was 46.8 years, 97.4% were male, and 54% were treated with thymidine analogues. Median baseline limb fat was 3.76 and 2.99 kg in the rosiglitazone and control groups, respectively. Median changes in arm, leg, trunk, and total body fat at 24 weeks were not significantly different between groups (7.1% vs. 5.0% [P = .94]; 0.1% vs. −2.4% [P = .90]; 1.2% vs. −1.4% [P = .81]; and 1.7% vs. 0.4% [P = .76]). There were no significant changes in secondary end points. There was no correlation between changes in body fat or treatment-arm and CD36 expression. Conclusions. This randomized, placebo-controlled trial did not show benefit of 4 mg/day of rosiglitazone on lipoatrophy or metabolic parameters in patients with HIV lipodystrophy.
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DOI: 10.1086/518005
Affiliations:
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Kain</name></author><author><name sortKey="Cheung, Angela" sort="Cheung, Angela" uniqKey="Cheung A" first="Angela" last="Cheung">Angela Cheung</name></author><author><name sortKey="Walmsley, Sharon" sort="Walmsley, Sharon" uniqKey="Walmsley S" first="Sharon" last="Walmsley">Sharon Walmsley</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:ED93231AD72953A727A48C826EFF042858119244</idno><date when="2007" year="2007">2007</date><idno type="doi">10.1086/518005</idno><idno type="url">https://api.istex.fr/ark:/67375/HXZ-GL3MFWH9-F/fulltext.pdf</idno><idno type="wicri:Area/Istex/Corpus">001885</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001885</idno><idno type="wicri:Area/Istex/Curation">001885</idno><idno type="wicri:Area/Istex/Checkpoint">001185</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">001185</idno><idno type="wicri:doubleKey">0022-1899:2007:Cavalcanti R:a:randomized:placebo</idno><idno type="wicri:Area/Main/Merge">003996</idno><idno type="wicri:Area/Main/Curation">003842</idno><idno type="wicri:Area/Main/Exploration">003842</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">A Randomized, Placebo-Controlled Trial of Rosiglitazone for HIV-Related Lipoatrophy</title><author><name sortKey="Cavalcanti, Rodrigo B" sort="Cavalcanti, Rodrigo B" uniqKey="Cavalcanti R" first="Rodrigo B." last="Cavalcanti">Rodrigo B. Cavalcanti</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Canada</country></affiliation><affiliation wicri:level="1"><country>Canada</country><wicri:regionArea>Reprints or correspondence: Dr. Rodrigo B. Cavalcanti, UHN—Toronto Western Hospital, East Wing 8-420, 399 Bathurst St., Toronto, ON</wicri:regionArea><wicri:noRegion>ON</wicri:noRegion></affiliation></author><author><name sortKey="Raboud, Janet" sort="Raboud, Janet" uniqKey="Raboud J" first="Janet" last="Raboud">Janet Raboud</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Shen, Sandy" sort="Shen, Sandy" uniqKey="Shen S" first="Sandy" last="Shen">Sandy Shen</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Kain, Kevin C" sort="Kain, Kevin C" uniqKey="Kain K" first="Kevin C." last="Kain">Kevin C. Kain</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>McLaughlin-Rotman Centre, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Cheung, Angela" sort="Cheung, Angela" uniqKey="Cheung A" first="Angela" last="Cheung">Angela Cheung</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation><affiliation wicri:level="4"><country xml:lang="fr">Canada</country><wicri:regionArea>University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Walmsley, Sharon" sort="Walmsley, Sharon" uniqKey="Walmsley S" first="Sharon" last="Walmsley">Sharon Walmsley</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Medicine, University Health Network, Ontario</wicri:regionArea><wicri:noRegion>Ontario</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">The Journal of Infectious Diseases</title><title level="j" type="abbrev">The Journal of Infectious Diseases</title><idno type="ISSN">0022-1899</idno><idno type="eISSN">1537-6613</idno><imprint><publisher>The University of Chicago Press</publisher><date type="published">2007</date><biblScope unit="vol">195</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1754">1754</biblScope><biblScope unit="page" to="1761">1761</biblScope></imprint><idno type="ISSN">0022-1899</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0022-1899</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">Background. Thiazolidinediones such as rosiglitazone may have benefit in ameliorating human immunodeficiency virus (HIV) lipoatrophy. Methods. HIV-positive patients receiving stable, protease inhibitor—containing highly active antiretroviral therapy with HIV lipodystrophy were prospectively randomized to rosiglitazone (4 mg/day) or placebo. The primary end point was the 24-week percentage change in arm fat by dual-energy x-ray absorptiometry (DEXA). Clinical and anthropometric evaluations, fasting lipid parameters, oral glucose tolerance testing, CD36 expression, quality of life measures, and DEXA scanning were performed at baseline and week 24. Results. Seventy-eight of the 96 enrolled patients were evaluated. Median age was 46.8 years, 97.4% were male, and 54% were treated with thymidine analogues. Median baseline limb fat was 3.76 and 2.99 kg in the rosiglitazone and control groups, respectively. Median changes in arm, leg, trunk, and total body fat at 24 weeks were not significantly different between groups (7.1% vs. 5.0% [P = .94]; 0.1% vs. −2.4% [P = .90]; 1.2% vs. −1.4% [P = .81]; and 1.7% vs. 0.4% [P = .76]). There were no significant changes in secondary end points. There was no correlation between changes in body fat or treatment-arm and CD36 expression. Conclusions. This randomized, placebo-controlled trial did not show benefit of 4 mg/day of rosiglitazone on lipoatrophy or metabolic parameters in patients with HIV lipodystrophy.</div></front></TEI><affiliations><list><country><li>Canada</li></country><region><li>Ontario</li></region><settlement><li>Toronto</li></settlement><orgName><li>Université de Toronto</li></orgName></list><tree><country name="Canada"><noRegion><name sortKey="Cavalcanti, Rodrigo B" sort="Cavalcanti, Rodrigo B" uniqKey="Cavalcanti R" first="Rodrigo B." last="Cavalcanti">Rodrigo B. Cavalcanti</name></noRegion><name sortKey="Cavalcanti, Rodrigo B" sort="Cavalcanti, Rodrigo B" uniqKey="Cavalcanti R" first="Rodrigo B." last="Cavalcanti">Rodrigo B. Cavalcanti</name><name sortKey="Cavalcanti, Rodrigo B" sort="Cavalcanti, Rodrigo B" uniqKey="Cavalcanti R" first="Rodrigo B." last="Cavalcanti">Rodrigo B. Cavalcanti</name><name sortKey="Cavalcanti, Rodrigo B" sort="Cavalcanti, Rodrigo B" uniqKey="Cavalcanti R" first="Rodrigo B." last="Cavalcanti">Rodrigo B. Cavalcanti</name><name sortKey="Cheung, Angela" sort="Cheung, Angela" uniqKey="Cheung A" first="Angela" last="Cheung">Angela Cheung</name><name sortKey="Cheung, Angela" sort="Cheung, Angela" uniqKey="Cheung A" first="Angela" last="Cheung">Angela Cheung</name><name sortKey="Kain, Kevin C" sort="Kain, Kevin C" uniqKey="Kain K" first="Kevin C." last="Kain">Kevin C. Kain</name><name sortKey="Kain, Kevin C" sort="Kain, Kevin C" uniqKey="Kain K" first="Kevin C." last="Kain">Kevin C. Kain</name><name sortKey="Kain, Kevin C" sort="Kain, Kevin C" uniqKey="Kain K" first="Kevin C." last="Kain">Kevin C. Kain</name><name sortKey="Raboud, Janet" sort="Raboud, Janet" uniqKey="Raboud J" first="Janet" last="Raboud">Janet Raboud</name><name sortKey="Raboud, Janet" sort="Raboud, Janet" uniqKey="Raboud J" first="Janet" last="Raboud">Janet Raboud</name><name sortKey="Shen, Sandy" sort="Shen, Sandy" uniqKey="Shen S" first="Sandy" last="Shen">Sandy Shen</name><name sortKey="Walmsley, Sharon" sort="Walmsley, Sharon" uniqKey="Walmsley S" first="Sharon" last="Walmsley">Sharon Walmsley</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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