Clinical Trials

MainTitle

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

This study has been terminated
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis


Information provided by (Responsible Party)
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
History of Changes
Purpose

Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures

  • Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 112
Study Start Date: November 2003
Study Completion Date: July 2005

Detailed 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122668

Locations

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

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

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

More Information


Responsible Party: French National Agency for Research on AIDS and Viral Hepatitis  
ClinicalTrials.gov Identifier: NCT00122668   History of Changes  
Other Study ID Numbers: ANRS121 HIPPOCAMPE  
Study First Received: July 21, 2005  
Last Updated: November 14, 2005  

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV Protease Inhibitors
HIV-Associated Lipodystrophy Syndrome
HIV infections

Additional relevant MeSH terms:
Syndrome
HIV Infections
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.