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

• Status: Terminated
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: HIV Protease Inhibitors; Protease Inhibitors; Reverse Transcriptase Inhibitors

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