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, 2014
Last verified: July 2014
  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:
  • 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 ] [ Designated as safety issue: Yes ]
    The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Number of participants with HIV-1 RNA level <50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Participant's immunological status assessed by CD4+ lymphocyte count.

  • CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12 [ Time Frame: Baseline, Month 6 and Month 12 ] [ Designated as safety issue: No ]
    Participant's immunological status assessed by CD4+ lymphocyte count.


Enrollment: 52
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: January 16, 2014
Last Updated: July 31, 2014
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 August 26, 2014