Rosiglitazone Effect on Mitochondria and Lipoatrophy

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Placebo; Drug: Rosiglitazone

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00367744

AI060484-C (Other Grant/Funding Number)

AI060484-02-C

Details and patient eligibility

About

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).

Full description

This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups, including a placebo group

Rosigitazone arm

Active Comparator group

Description:

Rosiglitazone active 4 mg BID

Treatment:

Drug: Rosiglitazone

Placebo arm

Placebo Comparator group

Description:

Matching Placebo BID

Treatment:

Drug: Placebo