Clinical Trials

MainTitle

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

This study has been terminated
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

Collaborator
Takeda

Information provided by (Responsible Party)
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
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV-Associated Lipodystrophy Syndrome
HIV Infections

Drug : Pioglitazone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Therapy for at Least 6 Months.ANRS 113 LIPIOT Study

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

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

Estimated Enrollment: 130
Study Start Date: February 2003
Study Completion Date: October 2004

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148850

Locations

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

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis
Takeda

Investigators

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

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT00148850   History of Changes  
Other Study ID Numbers: ANRS 113 LIPIOT  
Study First Received: September 7, 2005  
Last Updated: October 19, 2005  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV-Associated Lipodystrophy Syndrome
pioglitazone
HIV infections
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Pioglitazone

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.