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Extension Study of Apricitabine in Treatment-experienced HIV-1
NCT00686270Phase 3
Key facts
- Status
- Withdrawn
- Start
- May 2008
- Primary completion
- May 2012
- Sponsor
- Avexa Limited
- Modality
- Small Molecules
- Drugs
- apricitabine
- Conditions
- human immunodeficiency virus infection (HIV)
01
Overview
Phase 3, open-label, single-arm trial of apricitabine in human immunodeficiency virus infection (HIV), sponsored by Avexa Limited. Primary endpoint: Number, type and severity of Serious Adverse Events at Week 96. Planned start May 2008; status: withdrawn.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Apricitabine Extension
Apricitabine + Background ART
03
Who it enrols
Patients who completed AVX-301 or AVX-302, or met criteria for virologic failure/lack of response in those studies. Must be 18 years or older. Excludes patients with acute/chronic Hepatitis B or current Hepatitis C treatment.
04
Endpoints
Primary
Number, type and severity of Serious Adverse Events
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