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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 4

Conditions

HIV-Associated Lipodystrophy Syndrome

HIV Infections

Treatments

Drug: nucleoside reverse transcriptase inhibitors

Drug: protease inhibitor

Drug: non-nucleoside reverse transcriptase inhibitors

Study type

Interventional

Funder types

Other

Identifiers

NCT00122668

ANRS121 HIPPOCAMPE

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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