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

NCT00824369

Last updated date
Study Location
Pfizer Investigational Site
Sacramento, California, 95814, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Concurrent treatment in another clinical trial.


- Unwilling or unable to be followed for 12 months

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
Official Title  ICMJE A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE HIV-1
Intervention  ICMJE Drug: No drug will be administered
No drug will be administered.
Study Arms  ICMJE No Intervention: Anti-retroviral therapy
Anti-retroviral therapy
Intervention: Drug: No drug will be administered
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2014)
52
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Italy,   Malaysia,   Poland,   Portugal,   Puerto Rico,   South Africa,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Australia,   Canada,   France,   Germany,   Mexico,   Spain,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00824369
Other Study ID Numbers  ICMJE A5271038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE ViiV Healthcare
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2014

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