A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022

• Status: Terminated
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborator: ViiV Healthcare
• Treatments: Efavirenz; Etravirine

Criteria

Inclusion Criteria:

• Patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).

• Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.

• For women who can have children, a negative urine pregnancy test at the Day 1 visit.

Exclusion Criteria:

• Patients with any Grade 4 Division of AIDS toxicity (except for lipids and asymptomatic glucose elevations will not be included in this trial.

• Patients being treated with another investigational product or in another clinical trial, except the lersivirine parent protocols will not be included in this trial.