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

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ClinicalTrials.gov Identifier: NCT00824369
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : January 16, 2009
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Collaborator:
ViiV Healthcare
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
HIV-1 Drug: No drug will be administered Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
No Intervention: Anti-retroviral therapy
Anti-retroviral therapy
Drug: No drug will be administered
No drug will be administered.



Primary Outcome Measures :
  1. Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events [ Time Frame: End of Study visit or the Early Termination visit ]
    The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.


Secondary Outcome Measures :
  1. Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit [ Time Frame: Baseline, Month 6, Month 12 and Last visit ]
    Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.

  2. Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit [ Time Frame: Baseline, Month 6, Month 12 and Last visit ]
    Number of participants with HIV-1 RNA level <50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.

  3. Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant's immunological status assessed by CD4+ lymphocyte count.

  4. CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 [ Time Frame: Baseline, Month 6 and Month 12 ]
    Participant's immunological status assessed by CD4+ lymphocyte count.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824369


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00824369     History of Changes
Other Study ID Numbers: A5271038
First Posted: January 16, 2009    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014
Last Verified: July 2014

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