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

• Status: Terminated
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: HIV Protease Inhibitors; Protease Inhibitors; Reverse Transcriptase Inhibitors

Criteria

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