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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV-Associated Lipodystrophy Syndrome HIV Infections

Keywords

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HIV-Associated Lipodystrophy Syndrome pioglitazone HIV infections Treatment Experienced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pioglitazone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Willy Rozenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Tenon Paris

Dominique Costagliola

Role: STUDY_CHAIR

INSERM U 720

Locations

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Service des Maladies Infectieuses et Tropicales, Hopital Tenon

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED

PMID: 18389900 (View on PubMed)

Other Identifiers

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ANRS 113 LIPIOT

Identifier Type: -

Identifier Source: org_study_id