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

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-08-24
• Study First Submitted QC: 2004-08-25
• Study First Posted: 2004-08-26
• Status Verified: 2006-02
• Last Update Submitted: 2006-02-24
• Last Update Posted: 2006-02-27

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

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇺🇸 Seattle, Washington, United States