Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects

NCT ID: NCT00197145

Last Updated: 2018-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-21

Study Completion Date

2007-09-11

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5-tropic virus

Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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GW873140

Group Type EXPERIMENTAL

GW873140

Intervention Type DRUG

400 mg twice daily

Interventions

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GW873140

400 mg twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV-infected.
* Screening viral load at least 5000copies/mL.
* R5-tropic only virus at screening.
* Total prior antiretroviral experience of at least 3 months and documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI).
* Stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
* Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
* Women of childbearing potential must use specific forms of contraception.

Exclusion Criteria

* Acute laboratory abnormalities.
* History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
* R5/X4-tropic, X4-tropic only, or non-phenotypeable virus at screening.
* Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
* Pregnancy or breastfeeding women.
* Recent participation in an experimental drug trial.
* Prior use of a CCR5 or CXCR4 antagonist.
* Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
* Current use of certain medications may exclude participation in this study.
* Additional qualifying criteria and laboratory test requirements to be assessed by study physician.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Beverly Hills, California, United States

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Fountain Valley, California, United States

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Laguna Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Oakland, California, United States

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San Francisco, California, United States

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Tarzana, California, United States

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Glastonbury, Connecticut, United States

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Norwalk, Connecticut, United States

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

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

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Key West, Florida, United States

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Miami, Florida, United States

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Oakland Park, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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East Orange, New Jersey, United States

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Hillsborough, New Jersey, United States

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Newark, New Jersey, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Akron, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Annandale, Virginia, United States

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Hampton, Virginia, United States

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Lynchburg, Virginia, United States

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Spokane, Washington, United States

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Toronto, Ontario, Canada

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Ponce, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Canada Puerto Rico

Other Identifiers

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CCR102709

Identifier Type: -

Identifier Source: org_study_id

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