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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: 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)

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 Summary:

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.


Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Current Primary Outcome: Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96

Original Primary Outcome: Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and W96

Current Secondary Outcome:

  • 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)


Original Secondary Outcome:

  • 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 WHO-QOL-HIV BREF


Information By: French National Agency for Research on AIDS and Viral Hepatitis

Dates:
Date Received: July 21, 2005
Date Started: November 2003
Date Completion: July 2005
Last Updated: November 14, 2005
Last Verified: November 2005