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

NCT ID: NCT00046332

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-01-31

Brief Summary

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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

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Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW810781

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trial, MD,MPH

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Phoenix, Arizona, United States

Site Status

GSK Clinical Trials Call Center

Los Angeles, California, United States

Site Status

GSK Clinical Trials Call Center

San Diego, California, United States

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GSK Clinical Trials Call Center

San Francisco, California, United States

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GSK Clinical Trials Call Center

West Hollywood, California, United States

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GSK Clinical Trials Call Center

Denver, Colorado, United States

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GSK Clinical Trials Call Center

Washington D.C., District of Columbia, United States

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GSK Clinical Trials Call Center

Altamonte Springs, Florida, United States

Site Status

GSK Clinical Trials Call Center

Fort Lauderdale, Florida, United States

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GSK Clinical Trials Call Center

Miami, Florida, United States

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GSK Clinical Trials Call Center

Tampa, Florida, United States

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GSK Clinical Trials Call Center

Atlanta, Georgia, United States

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GSK Clinical Trials Call Center

Indianapolis, Indiana, United States

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GSK Clinical Trials Call Center

Minneapolis, Minnesota, United States

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GSK Clinical Trials Call Center

New York, New York, United States

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GSK Clinical Trials Call Center

New York, New York, United States

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GSK Clinical Trials Call Center

New York, New York, United States

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GSK Clinical Trials Call Center

The Bronx, New York, United States

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GSK Clinical Trials Call Center

Chapel Hill, North Carolina, United States

Site Status

GSK Clinical Trials Call Center

Charlotte, North Carolina, United States

Site Status

GSK Clinical Trials Call Center

Durham, North Carolina, United States

Site Status

GSK Clinical Trials Call Center

Dallas, Texas, United States

Site Status

GSK Clinical Trials Call Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ITG20001

Identifier Type: -

Identifier Source: org_study_id

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