Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Collaborating Sponsors:
ViiV Healthcare
Conditions:
HIV-1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01254656
Start Date
February 1 2011
End Date
April 1 2013
Last Update
June 9 2014
Active Locations (23)
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1
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
2
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
3
Pfizer Investigational Site
Nova Iguaçu, Rio de Janeiro, Brazil, 26030-381
4
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 1K2