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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148850
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : October 20, 2005
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

September 7, 2005
September 8, 2005
October 20, 2005
February 2003
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Evolution from inclusion to week 48 of limb fat using DEXA Scan (Dual Energy X-ray Absorptiometry)
Same as current
Complete list of historical versions of study NCT00148850 on Archive Site
  • 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
Same as current
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Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
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 Therapy for at Least 6 Months.ANRS 113 LIPIOT Study
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • HIV-Associated Lipodystrophy Syndrome
  • HIV Infections
Drug: Pioglitazone
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Slama L, Lanoy E, Valantin MA, Bastard JP, Chermak A, Boutekatjirt A, William-Faltaos D, Billaud E, Molina JM, Capeau J, Costagliola D, Rozenbaum W. Effect of pioglitazone on HIV-1-related lipodystrophy: a randomized double-blind placebo-controlled trial (ANRS 113). Antivir Ther. 2008;13(1):67-76.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2004
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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French National Agency for Research on AIDS and Viral Hepatitis
Principal Investigator: Willy Rozenbaum, MD Hopital Tenon Paris
Study Chair: Dominique Costagliola INSERM U 720
French National Agency for Research on AIDS and Viral Hepatitis
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP