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

HIV Infections Clinical Trial

Official title:

A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046332
• Other study ID #: ITG20001
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2002
• Last updated: February 20, 2013
• Start date: June 2002
• Est. completion date: January 2003

Study information

• Verified date: February 2013
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• GW810781

Locations

Country	Name	City	State
United States	GSK Clinical Trials Call Center	Altamonte Springs	Florida
United States	GSK Clinical Trials Call Center	Atlanta	Georgia
United States	GSK Clinical Trials Call Center	Bronx	New York
United States	GSK Clinical Trials Call Center	Chapel Hill	North Carolina
United States	GSK Clinical Trials Call Center	Charlotte	North Carolina
United States	GSK Clinical Trials Call Center	Dallas	Texas
United States	GSK Clinical Trials Call Center	Denver	Colorado
United States	GSK Clinical Trials Call Center	Durham	North Carolina
United States	GSK Clinical Trials Call Center	Ft. Lauderdale	Florida
United States	GSK Clinical Trials Call Center	Houston	Texas
United States	GSK Clinical Trials Call Center	Indianapolis	Indiana
United States	GSK Clinical Trials Call Center	Los Angeles	California
United States	GSK Clinical Trials Call Center	Miami	Florida
United States	GSK Clinical Trials Call Center	Minneapolis	Minnesota
United States	GSK Clinical Trials Call Center	New York	New York
United States	GSK Clinical Trials Call Center	New York	New York
United States	GSK Clinical Trials Call Center	New York	New York
United States	GSK Clinical Trials Call Center	Phoenix	Arizona
United States	GSK Clinical Trials Call Center	San Diego	California
United States	GSK Clinical Trials Call Center	San Francisco	California
United States	GSK Clinical Trials Call Center	Tampa	Florida
United States	GSK Clinical Trials Call Center	Washington	District of Columbia
United States	GSK Clinical Trials Call Center	West Hollywood	California

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma HIV-1 RNA change from baseline by Day 11.
Secondary	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.