Text Size

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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00824369
First received: January 15, 2009
Last updated: May 22, 2013
Last verified: May 2013
History of Changes

January 15, 2009
May 22, 2013
July 2009
August 2017   (final data collection date for primary outcome measure)
Safety assessed by adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00824369 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV-1
Drug: No drug will be administered
No drug will be administered.
No Intervention: Anti-retroviral therapy
Anti-retroviral therapy
Intervention: Drug: No drug will be administered
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
47
August 2017
August 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Italy,   Malaysia,   Poland,   Portugal,   Puerto Rico,   South Africa,   Switzerland,   Ukraine,   United Kingdom
 
NCT00824369
A5271038
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP