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

October 19, 2005 updated by: French National Agency for Research on AIDS and Viral Hepatitis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75020
        • Service des Maladies Infectieuses et Tropicales, Hopital Tenon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Collaborators

Takeda

Investigators

  • Study Chair: Dominique Costagliola, INSERM U 720
  • Principal Investigator: Willy Rozenbaum, MD, Hopital Tenon Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

October 20, 2005

Last Update Submitted That Met QC Criteria

October 19, 2005

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 113 LIPIOT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Pioglitazone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe