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

This study has been completed.
Sponsor:
Collaborator:
Shionogi
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00046332
First received: September 26, 2002
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: GW810781
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 100
Study Start Date: June 2002
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046332

Locations
United States, Arizona
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85006
United States, California
GSK Clinical Trials Call Center
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
United States, Colorado
GSK Clinical Trials Call Center
Denver, Colorado, United States, 80220
United States, District of Columbia
GSK Clinical Trials Call Center
Washington, District of Columbia, United States, 20007
United States, Florida
GSK Clinical Trials Call Center
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
United States, Georgia
GSK Clinical Trials Call Center
Atlanta, Georgia, United States, 30308
United States, Indiana
GSK Clinical Trials Call Center
Indianapolis, Indiana, United States, 46202
United States, Minnesota
GSK Clinical Trials Call Center
Minneapolis, Minnesota, United States, 55404
United States, New York
GSK Clinical Trials Call Center
Bronx, New York, United States, 10461
GSK Clinical Trials Call Center
New York, New York, United States, 10008
GSK Clinical Trials Call Center
New York, New York, United States, 10032
GSK Clinical Trials Call Center
New York, New York, United States, 10011
United States, North Carolina
GSK Clinical Trials Call Center
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
United States, Texas
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75235
GSK Clinical Trials Call Center
Houston, Texas, United States, 77004
Sponsors and Collaborators
GlaxoSmithKline
Shionogi
Investigators
Study Director: GSK Clinical Trial, MD,MPH GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046332     History of Changes
Other Study ID Numbers: ITG20001
Study First Received: September 26, 2002
Last Updated: February 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Integrase inhibitors
Monotherapy
HIV-1 infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014