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Sponsored by: |
French National Agency for Research on AIDS and Viral Hepatitis |
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Information provided by: | French National Agency for Research on AIDS and Viral Hepatitis |
ClinicalTrials.gov Identifier: | NCT00122668 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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) |
Estimated Enrollment: | 112 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | July 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Platelets below 20 000/mm3
France | |
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere | |
Paris, France, 75013 |
Principal Investigator: | Claudine Duvivier, MD | Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris |
Study Chair: | Dominique Costagliola | INSERM U 720 |
Study ID Numbers: | ANRS121 HIPPOCAMPE |
Study First Received: | July 21, 2005 |
Last Updated: | November 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00122668 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
HIV Protease Inhibitors HIV-Associated Lipodystrophy Syndrome HIV infections |
Anti-Infective Agents HIV Protease Inhibitors Sexually Transmitted Diseases, Viral Metabolic Diseases Skin Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors |
Virus Diseases HIV-Associated Lipodystrophy Syndrome Anti-Retroviral Agents HIV Infections Lipodystrophy Sexually Transmitted Diseases Retroviridae Infections Metabolic Disorder Lipid Metabolism Disorders |
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Pathologic Processes Anti-Retroviral Agents Therapeutic Uses Syndrome Lipodystrophy Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Metabolic Diseases |
Disease Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Protease Inhibitors Virus Diseases HIV-Associated Lipodystrophy Syndrome HIV Infections Skin Diseases, Metabolic Sexually Transmitted Diseases Lentivirus Infections |