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
sites
Hampton, Virginia 23666
1174
mi
from
Hampton, VA
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Akron, Ohio 44313
896
mi
from
Akron, OH
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Annandale, Virginia 22003
1118
mi
from
Annandale, VA
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Atlanta, Georgia 30341
801
mi
from
Atlanta, GA
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Austin, Texas 78705
515
mi
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Austin, TX
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Baltimore, Maryland 21201
1148
mi
from
Baltimore, MD
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Beverly Hills, California 90211
1175
mi
from
Beverly Hills, CA
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Birmingham, Alabama 35249
676
mi
from
Birmingham, AL
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Boston, Massachusetts 02115
1444
mi
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Boston, MA
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Charlotte, North Carolina 28203
957
mi
from
Charlotte, NC
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Chicago, Illinois 60611
611
mi
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Chicago, IL
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Columbia, South Carolina 29203
969
mi
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Columbia, SC
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Dallas, Texas 75230
340
mi
from
Dallas, TX
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Decatur, Georgia 30033
805
mi
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Decatur, GA
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East Orange, New Jersey
1276
mi
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East Orange, NJ
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Fort Lauderdale, Florida 33308
1306
mi
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Fort Lauderdale, FL
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Fort Myers, Florida 33916
1207
mi
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Fort Myers, FL
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Fountain Valley, California 92708
1160
mi
from
Fountain Valley, CA
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Glastonbury, Connecticut 06033
1362
mi
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Glastonbury, CT
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Hillsborough, New Jersey 08844
1252
mi
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Hillsborough, NJ
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Houston, Texas 77030
572
mi
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Houston, TX
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Key West, Florida 33040
1311
mi
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Key West, FL
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Laguna Beach, California 90803
1155
mi
from
Laguna Beach, CA
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Las Vegas, Nevada 89102
963
mi
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Las Vegas, NV
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Long Beach, California 90813
1172
mi
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Long Beach, CA
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Los Angeles, California 90025
1179
mi
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Los Angeles, CA
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Lynchburg, Virginia 24501
1021
mi
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Lynchburg, VA
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Miami, Florida 33136
1320
mi
from
Miami, FL
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Minneapolis, Minnesota 55404
551
mi
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Minneapolis, MN
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Mount Vernon, New York 10550
1053
mi
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Mount Vernon, NY
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New Orleans, Louisiana 70112
697
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New Orleans, LA
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New York, New York 10032
1290
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New York, NY
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Newark, New Jersey 07112
1276
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Newark, NJ
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Norwalk, Connecticut 06850
1316
mi
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Norwalk, CT
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Oakland, California 94611
1327
mi
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Oakland, CA
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Oakland Park, Florida 33309
1302
mi
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Oakland Park, FL
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Orlando, Florida 32806
1144
mi
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Orlando, FL
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Plantation, Florida 33324
1302
mi
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Plantation, FL
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Portland, Maine 04101
1492
mi
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Portland, ME
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Portland, Oregon 97227
1384
mi
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Portland, OR
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Saint Louis, Missouri 63110
415
mi
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Saint Louis, MO
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San Francisco, California 94115
1340
mi
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San Francisco, CA
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Spokane, Washington 99208
1208
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Spokane, WA
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Tarzana, California 91356
1182
mi
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Tarzana, CA
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Toronto, Ontario
1045
mi
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Toronto,
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Washington, District of Columbia 20007
1127
mi
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Washington,
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Wichita, Kansas 67207
32
mi
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Wichita, KS
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