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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: HIV-1

Treatments: Drug: etravirine; Drug: lersivirine; Drug: efavirenz

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254656

A5271037

Details and patient eligibility

About

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.

Full description

The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 6 patient groups

LRV 500mg

Experimental group

Treatment:

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

LRV 750mg +TVD

Experimental group

Treatment:

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

EFV

Active Comparator group

Treatment:

Drug: efavirenz

LRV 750mg+ DRV/r + OBT

Experimental group

Treatment:

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

LRV 1000mg +DRV/r + OBT

Experimental group

Treatment:

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

Drug: lersivirine

ETR

Active Comparator group

Treatment:

Drug: etravirine