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

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ClinicalTrials.gov Identifier: NCT00148850
Recruitment Status : Terminated
First Posted : September 8, 2005
Last Update Posted : October 20, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
HIV-Associated Lipodystrophy Syndrome HIV Infections Drug: Pioglitazone Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
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
Study Start Date : February 2003
Estimated Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Changes from inclusion to week 48:
  2. Lipid profile and the glucidic metabolism
  3. SAT/TAT and VAT/TAT ratios evaluated with scanner
  4. X ray of L4
  5. Anthropometric measurements and the quality of life (WHO-QOL-HIV BREF)
  6. Evaluation of clinical and biological safety

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00148850     History of Changes
Other Study ID Numbers: ANRS 113 LIPIOT
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 20, 2005
Last Verified: September 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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs