NCT00824369

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

A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• HIV-1

Interventions

Type	Name	Description
DRUG	No drug will be administered	No drug will be administered.

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-01-16
• Last updated: 2014-08-04
• Results posted: 2014-08-04

Locations

27 sites across 12 countries: United States, Argentina, Brazil, Italy, Malaysia, Poland, Portugal, Puerto Rico, South Africa, Switzerland, Ukraine, United Kingdom