Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
NCT ID: NCT00090077
Last Updated: 2006-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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GW695634
Eligibility Criteria
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Inclusion Criteria
* HIV-1 RNA \>2000 copies/mL.
* Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.
* Normal resting 12-lead electrocardiogram.
Exclusion Criteria
* Chronic diarrhea (\>3 loose stools/day).
* An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.
* Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.
* Any acute laboratory abnormality.
* Positive for HCV antibody or HepBsAG.
* Active infections requiring therapy in the previous 4 weeks.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Principal Investigators
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GSK Clinical Trial, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Clinical Trials Call Center
Phoenix, Arizona, United States
GSK Clinical Trials Call Center
Fountain Valley, California, United States
GSK Clinical Trials Call Center
San Francisco, California, United States
GSK Clinical Trials Call Center
West Hollywood, California, United States
GSK Clinical Trials Call Center
Washington D.C., District of Columbia, United States
GSK Clinical Trials Call Center
Fort Lauderdale, Florida, United States
GSK Clinical Trials Call Center
Miami, Florida, United States
GSK Clinical Trials Call Center
Miami Beach, Florida, United States
GSK Clinical Trials Call Center
Orlando, Florida, United States
GSK Clinical Trials Call Center
Vero Beach, Florida, United States
GSK Clinical Trials Call Center
Atlanta, Georgia, United States
GSK Clinical Trials Call Center
Boston, Massachusetts, United States
GSK Clinical Trials Call Center
Las Vegas, Nevada, United States
GSK Clinical Trials Call Center
New York, New York, United States
GSK Clinical Trials Call Center
Charlotte, North Carolina, United States
GSK Clinical Trials Call Center
Oklahoma City, Oklahoma, United States
GSK Clinical Trials Call Center
Fort Worth, Texas, United States
GSK Clinical Trials Call Center
Seattle, Washington, United States
Countries
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Other Identifiers
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NN210005
Identifier Type: -
Identifier Source: org_study_id