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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: | NCT00122655 |
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression.
Maintenance of virological suppression and immunological factors are also assessed.
Condition | Intervention | Phase |
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HIV Infections HIV Lipodystrophy Syndrome |
Drug: non-nucleoside reverse transcriptase inhibitors Drug: nucleoside reverse transcriptase inhibitors Drug: protease inhibitors |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study |
Estimated Enrollment: | 100 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | June 2005 |
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associated toxicities. The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (NRTIs). Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere | |
Paris, France, 75013 |
Principal Investigator: | Marc Antoine Valantin, MD | Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris |
Study Chair: | Dominique Costagliola | INSERM U720 |
Study ID Numbers: | ANRS108 NONUKE |
Study First Received: | July 21, 2005 |
Last Updated: | November 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00122655 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
HIV infections HIV Lipodystrophy Syndrome |
Anti-Infective Agents 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 |