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).

Condition	Intervention	Phase
HIV Infections HIV-Associated Lipodystrophy Syndrome	Drug: non-nucleoside reverse transcriptase inhibitors  Drug: nucleoside reverse transcriptase inhibitors  Drug: protease inhibitor	Phase IV

Further Study Details: 

Primary Outcomes: Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Secondary Outcomes: 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)
Expected Total Enrollment:  112

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

France
      Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere, Paris,  75013,  France

Study chairs or principal investigators

Claudine Duvivier, MD,  Principal Investigator,  Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris   
Dominique Costagliola,  Study Chair,  INSERM U 720   

Study ID Numbers:  ANRS121 HIPPOCAMPE
Last Updated:  July 29, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122668
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-08-23