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Rollover Study for Subjects Discontinuing Lersivirine (UK-453,061)
NCT00824369Phase 2
Key facts
- Status
- Terminated
- Start
- Jul 2009
- Primary completion
- Jul 2013
- Countries
- 12
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- lersivirine
- Conditions
- human immunodeficiency virus type 1 infection (HIV-1)
01
Overview
Phase 2, open-label, single-arm trial of lersivirine in human immunodeficiency virus type 1 infection (HIV-1), sponsored by Pfizer. Primary endpoint: Treatment-emergent Adverse Events. Started Jul 2009; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Anti-retroviral therapy
No drug administered by the study; patients receive standard of care.
03
Who it enrols
Patients who discontinued from UK-453,061 qualifying studies.
04
Endpoints
Primary
Treatment-emergent Adverse Events
Secondary
HIV-1 RNA <50 copies/mL
Absolute CD4+ Cell Count
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