A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00046332
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-09-26
• Study First Submitted QC: 2002-09-27
• Study First Posted: 2002-09-30
• Primary Completion: 2003-01
• Study Completion: 2003-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• No prior HIV medications.
• HIV infection with viral load >400-50,000 copies/mL.
• CD4 cell count >50 cells/mm.

Exclusion Criteria

• Patients requiring medications that cannot be interrupted for the duration of the study.
• Abnormal ECG or other chronic health conditions as noted on screening physical exam.
• Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma HIV-1 RNA change from baseline by Day 11.

Secondary Outcome Measures

Name	Time	Method
HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇺🇸 Houston, Texas, United States