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No effect of rosiglitazone for treatment of HIV-1 lipoatrophy: randomised, double-blind, placebo-controlled trial

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dc.contributor.authorCarr, A.
dc.contributor.authorWorkman, C.
dc.contributor.authorCarey, D.
dc.contributor.authorRogers, G.
dc.contributor.authorMartin, A.
dc.contributor.authorBaker, D.
dc.contributor.authorWand, H.
dc.contributor.authorLaw, M.
dc.contributor.authorSamaras, K.
dc.contributor.authorEmery, S.
dc.contributor.authorCooper, D.
dc.date.issued2004
dc.description.abstract<h4>Background</h4>Lipodystrophy commonly complicates antiretroviral therapy of HIV-1 infection. Thiazolidinediones such as rosiglitazone promote subcutaneous fat growth in type 2 diabetics and adults with congenital lipodystrophy, and can prevent HIV-1 protease inhibitor toxicity to adipocytes in vitro. We postulated that rosiglitazone would improve HIV lipoatrophy.<h4>Methods</h4>108 HIV-1-infected lipoatrophic adults on antiretroviral therapy were randomised to rosiglitazone 4 mg twice daily (n=53) or matching placebo (n=55) for 48 weeks. The study had 80% power to detect a 0.5 kg difference in changes in limb fat (using dual-energy X-ray absorptiometry) between groups at week 48 by intention-to-treat analysis, and a 0.7 kg difference within each protease inhibitor stratum.<h4>Findings</h4>Limb fat increased by 0.14 kg in the rosiglitazone group and 0.18 kg in the placebo group (mean difference -0.04 kg [95%CI -0.29 to 0.21]; p=0.74 by t test), with three participants (one on rosiglitazone and two controls), lost to follow-up. Rosiglitazone had no significant benefit on any other measure of lipodystrophy, despite large relative increases in plasma adiponectin (4.2 mmol/L [102%]; p<0.0001) and in three markers of insulin sensitivity (p=0.01 to 0.02). Six participants ceased study drug in each group, four participants (three on rosiglitazone and one control) for related adverse events. The main adverse effects, which seem to be almost unique to this population, were asymptomatic hypertriglyceridaemia (mean relative increase 0.9 mmol/L at week 48; p=0.04) and hypercholesterolaemia (1.5 mmol/L; p=0.001).<h4>Interpretation</h4>Rosiglitazone for 48 weeks did not improve lipoatrophy in HIV-1-infected adults receiving antiretroviral therapy. Use of less toxic antiretroviral treatment is necessary to prevent lipoatrophy.
dc.description.statementofresponsibilityAndrew Carr, Cassy Workman, Dianne Carey, Gary Rogers, Allison Martin, David Baker, Handan Wand, Matthew Law, Katherine Samaras, Sean Emery and David A Cooper for the Rosey investigators
dc.identifier.citationThe Lancet, 2004; 363(9407):429-438
dc.identifier.doi10.1016/S0140-6736(04)15489-5
dc.identifier.issn0140-6736
dc.identifier.issn1474-547X
dc.identifier.orcidRogers, G. [0000-0003-4655-0131]
dc.identifier.urihttp://hdl.handle.net/2440/6202
dc.language.isoen
dc.publisherLancet Ltd
dc.rightsCopyright © 2004 Elsevier Ltd All rights reserved.
dc.source.urihttps://doi.org/10.1016/s0140-6736(04)15489-5
dc.subjectRosey investigators
dc.subjectHumans
dc.subjectHIV-1
dc.subjectHIV-Associated Lipodystrophy Syndrome
dc.subjectAnemia
dc.subjectThiazolidinediones
dc.subjectPlacebos
dc.subjectHypoglycemic Agents
dc.subjectAnti-HIV Agents
dc.subjectCD4 Lymphocyte Count
dc.subjectTreatment Outcome
dc.subjectDrug Therapy, Combination
dc.subjectViral Load
dc.subjectDouble-Blind Method
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectRosiglitazone
dc.titleNo effect of rosiglitazone for treatment of HIV-1 lipoatrophy: randomised, double-blind, placebo-controlled trial
dc.typeJournal article
pubs.publication-statusPublished

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