Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy

NCT00122655 | Terminated Phase 4

• 1 other identifier: ANRS108 NONUKE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; HIV Lipodystrophy Syndrome

Keywords

HIV infections; HIV Lipodystrophy Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

non-nucleoside reverse transcriptase inhibitors DRUG

nucleoside reverse transcriptase inhibitors DRUG

protease inhibitors DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Paris, 75013, France

Location

MeSH Terms

Conditions

HIV Infections; HIV-Associated Lipodystrophy Syndrome

Interventions

Protease Inhibitors

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Marc Antoine Valantin, MD

  Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  INSERM U720

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: January 1, 2001
• Study Completion: June 1, 2005
• Last Updated: November 15, 2005

Record last verified: 2005-11

Locations

FR (1)