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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 26, 2002

Last Updated Date

February 20, 2013

Start Date ^ICMJE

June 2002

Primary Completion Date

January 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00046332 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Drug: GW810781

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

January 2003

Primary Completion Date

January 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00046332

Other Study ID Numbers ^ICMJE

ITG20001

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Shionogi

Investigators ^ICMJE

Study Director:

GSK Clinical Trial, MD,MPH

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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