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

This study has been terminated.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122668
First received: July 21, 2005
Last updated: November 14, 2005
Last verified: November 2005

July 21, 2005
November 14, 2005
November 2003
Not Provided
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and W96
Complete list of historical versions of study NCT00122668 on ClinicalTrials.gov Archive Site
  • 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)
  • 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
Not Provided
Not Provided
 
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
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)

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • HIV-Associated Lipodystrophy Syndrome
  • Drug: non-nucleoside reverse transcriptase inhibitors
  • Drug: nucleoside reverse transcriptase inhibitors
  • Drug: protease inhibitor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
112
July 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122668
ANRS121 HIPPOCAMPE
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Claudine Duvivier, MD Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris
Study Chair: Dominique Costagliola INSERM U 720
French National Agency for Research on AIDS and Viral Hepatitis
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP