A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022
NCT01254656
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Patients must complete of 96 weeks of treatment with lersivirine (or comparator where required by local regulation) in one of the parent protocols (A5271015 or A5271022).
- Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent protocol.
- For women who can have children, a negative urine pregnancy test at the Day 1 visit.
- Patients with any Grade 4 Division of AIDS toxicity (except for lipids and
asymptomatic glucose elevations will not be included in this trial.
- Patients being treated with another investigational product or in another clinical
trial, except the lersivirine parent protocols will not be included in this trial.
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Descriptive Information | ||||
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Brief Title ICMJE | A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022 | |||
Official Title ICMJE | A Long Term Open-Label Extension Study Of Lersivirine For The Treatment Of HIV-1 Infection | |||
Brief Summary | This is a study to assess long-term safety and efficacy of lersivirine in patients who have completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022. | |||
Detailed Description | 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: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | HIV-1 | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 108 | |||
Original Estimated Enrollment ICMJE | 165 | |||
Actual Study Completion Date ICMJE | April 2013 | |||
Actual Primary Completion Date | April 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | Australia, Brazil, Canada, Italy, Mexico, Poland, South Africa, Switzerland, United Kingdom | |||
Removed Location Countries | Puerto Rico, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01254656 | |||
Other Study ID Numbers ICMJE | A5271037 | |||
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 |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |