Status:
TERMINATED
Effect of Pioglitazone on HIV-1 Related Lipoatrophy: a Randomized, Double Blind, Placebo-Controlled Trial in 130 Patients
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Takeda
Conditions:
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00148850
Start Date
February 1 2003
End Date
October 1 2004
Last Update
October 20 2005
Active Locations (1)
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1
Service des Maladies Infectieuses et Tropicales, Hopital Tenon
Paris, France, 75020