A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

Pfizer

Status and phase: Terminated; Phase 2

Conditions: HIV-1

Treatments: Drug: No drug will be administered

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824369

A5271038

Details and patient eligibility

About

The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.

Full description

To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. 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: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previous participation in a qualifying study.
• Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.

Exclusion criteria

• Concurrent treatment in another clinical trial.
• Unwilling or unable to be followed for 12 months

Trial design

52 participants in 1 patient group

Anti-retroviral therapy

No Intervention group

Description:

Anti-retroviral therapy

Treatment:

Drug: No drug will be administered