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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:
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

January 15, 2009
July 31, 2014
July 2009
July 2013   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00824369 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
HIV-1
Drug: No drug will be administered
No drug will be administered.
No Intervention: Anti-retroviral therapy
Anti-retroviral therapy
Intervention: Drug: No drug will be administered
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
52
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Brazil,   Italy,   Malaysia,   Poland,   Portugal,   Puerto Rico,   South Africa,   Switzerland,   Ukraine,   United Kingdom
 
NCT00824369
A5271038
No
Pfizer
Pfizer
ViiV Healthcare
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP