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:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00824369
First received: January 15, 2009
Last updated: July 31, 2013
Last verified: July 2013
  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:


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: 53
Study Start Date: July 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Sacramento, California, United States, 95817
Pfizer Investigational Site
Sacramento, California, United States, 95814
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33137
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45267
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Argentina
Pfizer Investigational Site
Buenos Aires, Argentina, C1405BCH
Brazil
Pfizer Investigational Site
Curitiba, PR, Brazil, 80240-280
Pfizer Investigational Site
Nova Iguacu, RJ, Brazil, 26030-381
Pfizer Investigational Site
Campinas, SP, Brazil, 13015-080
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04121-000
Italy
Pfizer Investigational Site
Milano, Italy, 20127
Malaysia
Pfizer Investigational Site
Kota Bharu, Kelantan, Malaysia, 15586
Poland
Pfizer Investigational Site
Warszawa, Poland, 01-201
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1349-019
Pfizer Investigational Site
Porto, Portugal, 4200-319
Puerto Rico
Pfizer Investigational Site
Ponce, Puerto Rico, 00717-1563
Pfizer Investigational Site
Santurce, Puerto Rico, 00909
South Africa
Pfizer Investigational Site
Dundee, Kwazulu-Natal, South Africa, 3000
Pfizer Investigational Site
Cape Town, Western Cape, South Africa, 7925
Switzerland
Pfizer Investigational Site
Lugano, Switzerland, 6903
Pfizer Investigational Site
St. Gallen, Switzerland, 9007
Ukraine
Pfizer Investigational Site
Donetsk, Ukraine, 83045
United Kingdom
Pfizer Investigational Site
Edinburgh, United Kingdom, EH4 2XU
Pfizer Investigational Site
Edinburgh, United Kingdom, EH3 9HA
Pfizer Investigational Site
London, United Kingdom, SW10 9NH
Pfizer Investigational Site
Manchester, United Kingdom, M8 5RB
Sponsors and Collaborators
Pfizer
ViiV Healthcare
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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: July 31, 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 April 16, 2014