Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV+ Patients

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Nevirapine

Criteria

Main Inclusion criteria:

• Subject suffering with clinically evident fat redistribution including the lipodystrophic syndrome and/or with abnormal values of triglycerides, cholesterol and/or insulin resistance

• Subject on treatment with HAART including PIs for at least 9 months, without therapeutic changes for at least 6 months

• Baseline CD4+ >200 cells/mm3

• HIV-1 RNA levels <200 copies/mL at baseline and during the previous 6 months

Main Exclusion criteria:

• Subject with other serious or chronic disease unrelated to HIV

• Subject with active invasive infections

• Subject with Karnofsky score less than 50

• Prior NNRTs experience

• Documented or suspected acute hepatitis within 30 days prior to baseline visit, irrespective of AST and ALT values that are >5 ULN

• Subject receiving hypolipidemic and/or antidiabetic drugs at study entry

• Subjects with central nervous system disease or pre-existing mental disturbance

• Subjects on methadone chronic treatment at study entry