A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects|
- Safety assessed by adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Percentage of subjects with HIV 1 RNA level <50 copies/mL. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- CD4+ lymphocyte count (absolute and percentage). [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
No Intervention: Anti-retroviral therapy
Drug: No drug will be administered
No drug will be administered.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824369
Show 27 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|