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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)

Conditions
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HIV Infections, HIV-Associated Lipodystrophy Syndrome

Intervention / Treatment
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* Drug: non-nucleoside reverse transcriptase inhibitors
* Drug: nucleoside reverse transcriptase inhibitors
* Drug: protease inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: non-nucleoside reverse transcriptase inhibitors|nan|
|Drug: nucleoside reverse transcriptase inhibitors|nan|
|Drug: protease inhibitor|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 clinical safety |  |  | 
| Evaluation of lipohypertrophic syndrome |  |  | 
| Evaluation of glucidic and lipids metabolic profile |  |  | 
| Evaluation of mitochondrial toxicity |  |  | 
| 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 |  |  | 
| Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Protease Inhibitors, HIV-Associated Lipodystrophy Syndrome, HIV infections