Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 < 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.

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

Details

• Lead Sponsor: Hospital de Calella
• Treatments: Nevirapine

Criteria

Inclusion Criteria:

• Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.

• Age >= 18 years.

• Confirmed diagnosis of HIV-1 infection.

• Viral load < 50 copies/ml over the previous six months, including at least two consecutive determinations.

• Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.

• Acceptance and signature of the informed consent form.

Exclusion Criteria:

• Pregnant women or those who intend to become pregnant in the study period.

• Having had an active infection in the previous month.

• Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).

• Simultaneous treatment with methadone.

• Patients with serious hepatic dysfunction