Phase 2
N=71
Rosiglitazone Effect on Mitochondria and Lipoatrophy
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00367744 ↗Enrolled (actual)
71
Serious AEs
39.4%
Results posted
Feb 2017
Primary outcome: Primary: Change in Limb Fat at 48 Weeks — 448; 153 grams — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rosiglitazone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Limb Fat at 48 Weeks |
448; 153 | 0.02 sig |
| SECONDARY the Change in the Carotid IMT of the Common Carotid Artery |
0.10; 0.15 | — |
Summary
The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).
Eligibility Criteria
Inclusion Criteria
- Lipoatrophy
- Thymidine sparing ARV for at least 24 weeks
- Prior thymidine NRTIs for at least 12 months
Exclusion Criteria
- Diabetes
- Heart failure
- Liver disease
- Hormonal therapies
Data sourced from ClinicalTrials.gov (NCT00367744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.