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

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.

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: GW810781

• Study Type: Interventional
• Enrollment: 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Clinical Trials Call Center
  • California
    • Los Angeles, California, United States, 90048
      • GSK Clinical Trials Call Center
    • San Diego, California, United States, 92103
      • GSK Clinical Trials Call Center
    • San Francisco, California, United States, 94115
      • GSK Clinical Trials Call Center
    • West Hollywood, California, United States, 90069
      • GSK Clinical Trials Call Center
  • Colorado
    • Denver, Colorado, United States, 80220
      • GSK Clinical Trials Call Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • GSK Clinical Trials Call Center
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • GSK Clinical Trials Call Center
    • Ft. Lauderdale, Florida, United States, 33311
      • GSK Clinical Trials Call Center
    • Miami, Florida, United States, 33133
      • GSK Clinical Trials Call Center
    • Tampa, Florida, United States, 33614
      • GSK Clinical Trials Call Center
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • GSK Clinical Trials Call Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • GSK Clinical Trials Call Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • GSK Clinical Trials Call Center
  • New York
    • Bronx, New York, United States, 10461
      • GSK Clinical Trials Call Center
    • New York, New York, United States, 10032
      • GSK Clinical Trials Call Center
    • New York, New York, United States, 10008
      • GSK Clinical Trials Call Center
    • New York, New York, United States, 10011
      • GSK Clinical Trials Call Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • GSK Clinical Trials Call Center
    • Charlotte, North Carolina, United States, 28203
      • GSK Clinical Trials Call Center
    • Durham, North Carolina, United States, 27710
      • GSK Clinical Trials Call Center
  • Texas
    • Dallas, Texas, United States, 75235
      • GSK Clinical Trials Call Center
    • Houston, Texas, United States, 77004
      • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Plasma HIV-1 RNA change from baseline by Day 11.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Shionogi
• Investigators: Study Director: GSK Clinical Trial, MD,MPH, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Primary Completion (Actual): January 1, 2003
• Study Completion (Actual): January 1, 2003

Study Registration Dates

• First Submitted: September 26, 2002
• First Submitted That Met QC Criteria: September 27, 2002
• First Posted (Estimate): September 30, 2002

Study Record Updates

• Last Update Posted (Estimate): February 21, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Integrase inhibitors; Monotherapy; HIV-1 infection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ITG20001