Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
Phase 1
Completed
- Conditions
- HIV Infections
- Registration Number
- NCT00090077
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7
- Secondary Outcome Measures
Name Time Method Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the antiviral efficacy of GW695634G monotherapy in NNRTI-experienced HIV-1 patients compared to placebo?
How does GW695634G interact with HIV-1 reverse transcriptase in NNRTI-resistant strains?
What safety concerns are associated with GW695634G in ART-naive HIV-1 populations?
Are there specific biomarkers that correlate with response to GW695634G in phase I HIV trials?
What combination therapies are being explored with compounds similar to GW695634G for HIV-1 treatment resistance?
Trial Locations
- Locations (1)
GSK Clinical Trials Call Center
🇺🇸Seattle, Washington, United States
GSK Clinical Trials Call Center🇺🇸Seattle, Washington, United States