Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy
This study has been terminated.
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122655
First received: July 21, 2005
Last updated: November 14, 2005
Last verified: November 2005
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Purpose
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 |
|---|---|---|
|
HIV Infections HIV Lipodystrophy Syndrome |
Drug: non-nucleoside reverse transcriptase inhibitors Drug: nucleoside reverse transcriptase inhibitors Drug: protease inhibitors |
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: | A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs
Secondary Outcome Measures:
- Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
- Change in CD4 cell count between day 0 (D0) and week 48
- Change in lipid profile and glucidic metabolism between D0 and week 48
- Evolution of SAT/TAT and VAT/TAT between D0 and week 48
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and non-pregnant females
- Confirmed laboratory diagnosis of HIV infection
- Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3 months
- Viral load below 400 copies/ml
- Patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination
Exclusion Criteria:
- Current antiretroviral therapy with 3 classes of antiretroviral therapy
- Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
- Intolerance to nevirapine and efavirenz
- Acute opportunistic infection
- Diabetes
- Transaminase levels over 5 times above the upper normal limit
- Hepatitis B virus (HBV) co-infection if the patient is receiving lamivudine therapy
- Ongoing immunotherapy including interleukin-2 (IL-2) and interferon
- Pregnancy or planned pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122655
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: | Marc Antoine Valantin, MD | Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris |
| Study Chair: | Dominique Costagliola | INSERM U720 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00122655 History of Changes |
| Other Study ID Numbers: | ANRS108 NONUKE |
| 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 infections HIV Lipodystrophy Syndrome |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lipodystrophy HIV-Associated Lipodystrophy Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Skin Diseases, Metabolic |
Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Protease Inhibitors Reverse Transcriptase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013