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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Phase 3, Double Blind, Multicentre Trial, Evaluating the Effect of Pioglitazone Versus Placebo on Change in Lipoatrophy in HIV- 1 Infected Patients Treated With Stable Antiretroviral The

Brief 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.

Detailed Summary:

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.


Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Current Primary Outcome: Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes from inclusion to week 48:
  • Lipid profile and the glucidic metabolism
  • SAT/TAT and VAT/TAT ratios evaluated with scanner
  • X ray of L4
  • Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
  • Evaluation of clinical and biological safety


Original Secondary Outcome: Same as current

Information By: French National Agency for Research on AIDS and Viral Hepatitis

Dates:
Date Received: September 7, 2005
Date Started: February 2003
Date Completion: October 2004
Last Updated: October 19, 2005
Last Verified: September 2005