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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00046332
• Collaborator: Shionogi (Industry)
• Enrollment: 100
• Locations: 23
• Duration (Months): 7
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: GW810781	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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.
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Jan 1, 2003
• Actual Study Completion Date: Jan 1, 2003

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Clinical Trials Call Center	Phoenix	Arizona	United States	85006
2	GSK Clinical Trials Call Center	Los Angeles	California	United States	90048
3	GSK Clinical Trials Call Center	San Diego	California	United States	92103
4	GSK Clinical Trials Call Center	San Francisco	California	United States	94115
5	GSK Clinical Trials Call Center	West Hollywood	California	United States	90069
6	GSK Clinical Trials Call Center	Denver	Colorado	United States	80220
7	GSK Clinical Trials Call Center	Washington	District of Columbia	United States	20007
8	GSK Clinical Trials Call Center	Altamonte Springs	Florida	United States	32701
9	GSK Clinical Trials Call Center	Ft. Lauderdale	Florida	United States	33311
10	GSK Clinical Trials Call Center	Miami	Florida	United States	33133
11	GSK Clinical Trials Call Center	Tampa	Florida	United States	33614
12	GSK Clinical Trials Call Center	Atlanta	Georgia	United States	30308
13	GSK Clinical Trials Call Center	Indianapolis	Indiana	United States	46202
14	GSK Clinical Trials Call Center	Minneapolis	Minnesota	United States	55404
15	GSK Clinical Trials Call Center	Bronx	New York	United States	10461
16	GSK Clinical Trials Call Center	New York	New York	United States	10008
17	GSK Clinical Trials Call Center	New York	New York	United States	10011
18	GSK Clinical Trials Call Center	New York	New York	United States	10032
19	GSK Clinical Trials Call Center	Chapel Hill	North Carolina	United States	27599
20	GSK Clinical Trials Call Center	Charlotte	North Carolina	United States	28203
21	GSK Clinical Trials Call Center	Durham	North Carolina	United States	27710
22	GSK Clinical Trials Call Center	Dallas	Texas	United States	75235
23	GSK Clinical Trials Call Center	Houston	Texas	United States	77004

Sponsors and Collaborators

• GlaxoSmithKline
• Shionogi

Investigators

• Study Director: GSK Clinical Trial, MD,MPH, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00046332
• Other Study ID Numbers: ITG20001
• First Posted: Sep 30, 2002
• Last Update Posted: Feb 21, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by , ,: Integrase inhibitors; Monotherapy; HIV-1 infection
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Feb 21, 2013