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

Use our guide to learn which trials are right for you!

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
Oakland Park, Florida 33309
1229
mi
from 02139
Oakland Park, FL
Click here to add this to my saved trials
Akron, Ohio 44313
545
mi
from 02139
Akron, OH
Click here to add this to my saved trials
Annandale, Virginia 22003
402
mi
from 02139
Annandale, VA
Click here to add this to my saved trials
Atlanta, Georgia 30341
923
mi
from 02139
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
1690
mi
from 02139
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21201
357
mi
from 02139
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
2595
mi
from 02139
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham, Alabama 35249
1052
mi
from 02139
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
2
mi
from 02139
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28203
720
mi
from 02139
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60611
845
mi
from 02139
Chicago, IL
Click here to add this to my saved trials
Columbia, South Carolina 29203
783
mi
from 02139
Columbia, SC
Click here to add this to my saved trials
Dallas, Texas 75230
1541
mi
from 02139
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
926
mi
from 02139
Decatur, GA
Click here to add this to my saved trials
East Orange, New Jersey
194
mi
from 02139
East Orange, NJ
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
1228
mi
from 02139
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Myers, Florida 33916
1245
mi
from 02139
Fort Myers, FL
Click here to add this to my saved trials
Fountain Valley, California 92708
2584
mi
from 02139
Fountain Valley, CA
Click here to add this to my saved trials
Glastonbury, Connecticut 06033
89
mi
from 02139
Glastonbury, CT
Click here to add this to my saved trials
Hampton, Virginia 23666
462
mi
from 02139
Hampton, VA
Click here to add this to my saved trials
Hillsborough, New Jersey 08844
223
mi
from 02139
Hillsborough, NJ
Click here to add this to my saved trials
Houston, Texas 77030
1605
mi
from 02139
Houston, TX
Click here to add this to my saved trials
Key West, Florida 33040
1373
mi
from 02139
Key West, FL
Click here to add this to my saved trials
Laguna Beach, California 90803
2581
mi
from 02139
Laguna Beach, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
2369
mi
from 02139
Las Vegas, NV
Click here to add this to my saved trials
Long Beach, California 90813
2594
mi
from 02139
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
2599
mi
from 02139
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
546
mi
from 02139
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33136
1256
mi
from 02139
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
1118
mi
from 02139
Minneapolis, MN
Click here to add this to my saved trials
Mount Vernon, New York 10550
397
mi
from 02139
Mount Vernon, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
1356
mi
from 02139
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10032
180
mi
from 02139
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07112
197
mi
from 02139
Newark, NJ
Click here to add this to my saved trials
Norwalk, Connecticut 06850
148
mi
from 02139
Norwalk, CT
Click here to add this to my saved trials
Oakland, California 94611
2677
mi
from 02139
Oakland, CA
Click here to add this to my saved trials
Orlando, Florida 32806
1115
mi
from 02139
Orlando, FL
Click here to add this to my saved trials
Plantation, Florida 33324
1237
mi
from 02139
Plantation, FL
Click here to add this to my saved trials
Portland, Maine 04101
99
mi
from 02139
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97227
2530
mi
from 02139
Portland, OR
Click here to add this to my saved trials
Saint Louis, Missouri 63110
1036
mi
from 02139
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94115
2691
mi
from 02139
San Francisco, CA
Click here to add this to my saved trials
Spokane, Washington 99208
2257
mi
from 02139
Spokane, WA
Click here to add this to my saved trials
Tarzana, California 91356
2600
mi
from 02139
Tarzana, CA
Click here to add this to my saved trials
Toronto, Ontario
427
mi
from 02139
Toronto,
Click here to add this to my saved trials
Washington, District of Columbia 20007
392
mi
from 02139
Washington,
Click here to add this to my saved trials
Wichita, Kansas 67207
1414
mi
from 02139
Wichita, KS
Click here to add this to my saved trials