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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GW810781
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Integrase inhibitors, Monotherapy, HIV-1 infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center
  • GSK Clinical Trials Call Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 26, 2002
Last Updated
February 20, 2013
Sponsor
GlaxoSmithKline
Collaborators
Shionogi
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1. Study Identification

Unique Protocol Identification Number
NCT00046332
Brief Title
A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline
Collaborators
Shionogi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Integrase inhibitors, Monotherapy, HIV-1 infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW810781
Primary Outcome Measure Information:
Title
Plasma HIV-1 RNA change from baseline by Day 11.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trial, MD,MPH
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Clinical Trials Call Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10008
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
GSK Clinical Trials Call Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

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

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