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

This study has been terminated.
Sponsor:
Collaborator:
Takeda
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00148850
First received: September 7, 2005
Last updated: October 19, 2005
Last verified: September 2005

September 7, 2005
October 19, 2005
February 2003
Not Provided
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV-Associated Lipodystrophy Syndrome
  • HIV Infections
Drug: Pioglitazone
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
October 2004
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00148850
ANRS 113 LIPIOT
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Takeda
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