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

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

MedlinePlus related topics:

AIDS

U.S. FDA Resources

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.

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

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

Keywords provided by GlaxoSmithKline:

Integrase inhibitors

Monotherapy

HIV-1 infection

Study placed in the following topic categories:

Virus Diseases

Sexually Transmitted Diseases, Viral

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	GlaxoSmithKline Shionogi
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00046332