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

This study is currently recruiting participants.
Verified April 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00824369
First received: January 15, 2009
Last updated: April 29, 2013
Last verified: April 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 ]

Estimated Enrollment: 330
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.

  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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  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: April 29, 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 16, 2013