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



Status:Terminated
Conditions:HIV / AIDS, HIV / AIDS, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/4/2018
Start Date:July 21, 2005
End Date:September 11, 2007

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A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Compare the Efficacy and Safety of GW873140 400mg BID in Combination With a Ritonavir-containing Optimized Background Therapy (OBT) Regimen Versus Placebo Plus OBT Over 48 Weeks.

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


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.
We found this trial at
47
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San Francisco, California 94115
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Akron, Ohio 44313
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Annandale, Virginia 22003
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Atlanta, Georgia 30341
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Austin, Texas 78705
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Baltimore, Maryland 21201
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Beverly Hills, California 90211
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Birmingham, Alabama 35249
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Boston, Massachusetts 02115
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Columbia, South Carolina 29203
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Dallas, Texas 75230
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Decatur, Georgia 30033
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East Orange, New Jersey
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Fort Lauderdale, Florida 33308
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Fort Myers, Florida 33916
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Fountain Valley, California 92708
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Glastonbury, Connecticut 06033
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Hampton, Virginia 23666
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Hillsborough, New Jersey 08844
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Houston, Texas 77030
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Key West, Florida 33040
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Laguna Beach, California 90803
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Las Vegas, Nevada 89102
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Long Beach, California 90813
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Los Angeles, California 90025
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Lynchburg, Virginia 24501
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Miami, Florida 33136
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Minneapolis, Minnesota 55404
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Mount Vernon, New York 10550
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New Orleans, Louisiana 70112
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New York, New York 10032
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Newark, New Jersey 07112
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Norwalk, Connecticut 06850
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Oakland, California 94611
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Oakland Park, Florida 33309
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Orlando, Florida 32806
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Plantation, Florida 33324
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Portland, Maine 04101
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Portland, Oregon 97227
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Saint Louis, Missouri 63110
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Spokane, Washington 99208
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Tarzana, California 91356
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Washington, District of Columbia 20007
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Wichita, Kansas 67207
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