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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


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
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00122668     History of Changes
Other Study ID Numbers: ANRS121 HIPPOCAMPE
Study First Received: July 21, 2005
Last Updated: November 14, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Infection
Lipodystrophy
Syndrome
Disease
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 25, 2014