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

Sponsor:	GlaxoSmithKline
Collaborator:	Shionogi
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00046332

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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

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

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
West Hollywood, California, United States, 90069
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
Los Angeles, California, United States, 90048
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
New York, New York, United States, 10008
GSK Clinical Trials Call Center
New York, New York, United States, 10032
GSK Clinical Trials Call Center
Bronx, New York, United States, 10461
GSK Clinical Trials Call Center
New York, New York, United States, 10011
United States, North Carolina
GSK Clinical Trials Call Center
Charlotte, North Carolina, United States, 28203
GSK Clinical Trials Call Center
Chapel Hill, North Carolina, United States, 27599
GSK Clinical Trials Call Center
Durham, North Carolina, United States, 27710
United States, Texas
GSK Clinical Trials Call Center
Houston, Texas, United States, 77004
GSK Clinical Trials Call Center
Dallas, Texas, United States, 75235

Sponsors and Collaborators

GlaxoSmithKline

Shionogi

Investigators

Study Director:

GSK Clinical Trial, MD,MPH

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	ITG20001
Study First Received:	September 26, 2002
Last Updated:	March 6, 2006
ClinicalTrials.gov Identifier:	NCT00046332 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Integrase inhibitors
Monotherapy
HIV-1 infection

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on November 09, 2009