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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
  Purpose

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.


Condition Intervention Phase
HIV-1
 Drug: No drug will be administered
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety assessed by adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 47
Study Start Date: July 2009
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Anti-retroviral therapy
Anti-retroviral therapy
 Drug: No drug will be administered
No drug will be administered.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824369

  Show 27 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00824369     History of Changes
Other Study ID Numbers: A5271038
Study First Received: January 15, 2009
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
HIV-1
Rollover
Safety.
HIV Infections
treatment experienced

ClinicalTrials.gov processed this record on May 22, 2013