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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 3

Conditions

HIV-Associated Lipodystrophy Syndrome

HIV Infections

Treatments

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00148850

ANRS 113 LIPIOT

Details and patient eligibility

About

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.

Full description

Lipodystrophy is one of the most frequent treatment side effect in HIV-1 infected patients. This complication can be stigmatizing in some affected patients and lead to reduced adherence to treatment, increased risk of cardiovascular complications and induce insulinoresistance. The pathophysiology of lipodystrophy remains poorly understood. Some antiretroviral drugs could be involved. Therefore, using PPAR G as a therapeutic target with the objective to reverse drug induced lipoatrophy appeared as a promising objective Thiazolidinediones are a new class of insulin sensitizing drugs for the treatment of type 2 diabetes. These PPARG agonist which mainly promote the differentiation of adipocytes, decrease circulating plasma free fatty acids. In non-HIV infected patients this class of drugs decreases intraabdominal fat accumulation and increases subcutaneous fat depot.

Different previous studies were performed with that aim, most of them using rosiglitazone.

We designed a prospective randomized, double blind placebo controlled multicentre study aiming to test the hypothesis that pioglitazone would improve lipoatrophy without deleterious effect on lipid profile in adult subjects receiving antiretroviral therapy.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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