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.

First Received: July 21, 2005 Last Updated: November 14, 2005 History of Changes

Sponsored by:	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

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 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

Resource links provided by NLM:

MedlinePlus related topics: 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

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

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

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

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV infections
HIV Lipodystrophy Syndrome

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on August 28, 2009