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

Last updated on December 16, 2017

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

NCT00824369
Pfizer
Terminated
A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1

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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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Italy,   Malaysia,   Poland,   Portugal,   Puerto Rico,   South Africa,   Switzerland,   Ukraine,   United Kingdom,   United States
Australia,   Canada,   France,   Germany,   Mexico,   Spain,   Taiwan
 
NCT00824369
A5271038
No
Not Provided
Not Provided
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

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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