Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients

Phase 4

Terminated

• Conditions: HIV-Associated Lipodystrophy Syndrome; HIV Infections

• Registration Number: NCT00122668
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary

The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).

Detailed Description

The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.

Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.

Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.

Study Timeline

• Study Start: 2003-11
• Study Completion: 2005-07
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Status Verified: 2005-11
• Last Update Submitted: 2005-11-14
• Last Update Posted: 2005-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Confirmed HIV-1-infected diagnosis
• Naive of antiretroviral treatment
• Plasma viral load (VL) over 5000 copies/ ml
• CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
• Written, informed consent after approval by the local human research ethics committee

Exclusion Criteria

• Acute opportunistic infection
• Pregnancy or breast feeding
• Cytotoxic systemic chemotherapy except for Kaposi sarcoma
• Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
• Polynuclear neutrophils below 750/mm3
• Hemoglobin below 8 g/dl
• Platelets below 20 000/mm3
• Creatinine level over 1.5 (upper normal) UN
• ASAT, ALAT, bilirubin level over 3 UN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96

Secondary Outcome Measures

Name	Time	Method
Evaluation of clinical safety
Evaluation of glucidic and lipids metabolic profile
During the study until 96 weeks
Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
Evolution of viral load
Evolution of CD4 lymphocytes
Evaluation of bone toxicity by measurement of bone density
Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
Evaluation of lipohypertrophic syndrome
Evaluation of mitochondrial toxicity
Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)

Trial Locations

Locations (1)

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere; 🇫🇷 Paris, France