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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:
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
  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:


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
Detailed Description:

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
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: 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:
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 27, 2014