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

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ClinicalTrials.gov Identifier: NCT00122668
Recruitment Status : Terminated
First Posted : July 22, 2005
Last Update Posted : November 15, 2005
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis

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).

Condition or disease Intervention/treatment Phase
HIV Infections HIV-Associated Lipodystrophy Syndrome Drug: non-nucleoside reverse transcriptase inhibitors Drug: nucleoside reverse transcriptase inhibitors Drug: protease inhibitor Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
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)
Study Start Date : November 2003
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. During the study until 96 weeks
  2. Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
  3. Evolution of viral load
  4. Evolution of CD4 lymphocytes
  5. Evaluation of clinical safety
  6. Evaluation of lipohypertrophic syndrome
  7. Evaluation of glucidic and lipids metabolic profile
  8. Evaluation of mitochondrial toxicity
  9. Evaluation of bone toxicity by measurement of bone density
  10. Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
  11. Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
  12. Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122668

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

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
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: November 15, 2005
Last Verified: November 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:
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Pathologic Processes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Protease Inhibitors
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors