Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients

• Status: Terminated
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Collaborator: Takeda
• Treatments: Pioglitazone

Criteria

Inclusion Criteria:

• 18 years of ages and older

• Confirmed laboratory diagnosis of HIV-1-infection

• Karnofsky equal or over 70%

• Patients treated with stable antiretroviral therapy for at least 6 months

• Plasma viral load below 400 copies/ ml and CD4 count over 200/mm3 for at least 6 months

• Patients with a clinical peripheral lipoatrophy self reported by the patient and confirmed by physical examination

Exclusion Criteria:

• Cachexia

• Cardiac failure class3 or 4 at NYHA classification

• Acute opportunistic infection

• Pregnancy or breast-feeding

• Polynuclear neutrophils below 1000/mm3

• Hemoglobin below 9 g/dl

• Platelets below 50 000/mm3

• Creatinine level over 2 UN

• ASAT, ALAT over 2.5UN

• Bilirubin, amylase, lipase level over 2 UN

• CD4 count below 200/mm3

• Patients treated by any antidiabetic or lipid lowering drugs, anabolic or corticosteroid hormone