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
Akron, Ohio 44313
2037
mi
from 91732
Akron, OH
Click here to add this to my saved trials
Annandale, Virginia 22003
2273
mi
from 91732
Annandale, VA
Click here to add this to my saved trials
Atlanta, Georgia 30341
1922
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
1211
mi
from 91732
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21201
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
21
mi
from 91732
Beverly Hills, CA
Click here to add this to my saved trials
Birmingham, Alabama 35249
1777
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02115
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28203
2100
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60611
1730
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Columbia, South Carolina 29203
2102
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
Dallas, Texas 75230
1223
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
East Orange, New Jersey
2422
mi
from 91732
East Orange, NJ
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
2315
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Myers, Florida 33916
2205
mi
from 91732
Fort Myers, FL
Click here to add this to my saved trials
Fountain Valley, California 92708
25
mi
from 91732
Fountain Valley, CA
Click here to add this to my saved trials
Glastonbury, Connecticut 06033
2501
mi
from 91732
Glastonbury, CT
Click here to add this to my saved trials
Hampton, Virginia 23666
2329
mi
from 91732
Hampton, VA
Click here to add this to my saved trials
Hillsborough, New Jersey 08844
2400
mi
from 91732
Hillsborough, NJ
Click here to add this to my saved trials
Houston, Texas 77030
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Key West, Florida 33040
2266
mi
from 91732
Key West, FL
Click here to add this to my saved trials
Laguna Beach, California 90803
39
mi
from 91732
Laguna Beach, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
214
mi
from 91732
Las Vegas, NV
Click here to add this to my saved trials
Long Beach, California 90813
22
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
24
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
2176
mi
from 91732
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33136
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
1509
mi
from 91732
Minneapolis, MN
Click here to add this to my saved trials
Mount Vernon, New York 10550
2179
mi
from 91732
Mount Vernon, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10032
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07112
2422
mi
from 91732
Newark, NJ
Click here to add this to my saved trials
Norwalk, Connecticut 06850
2459
mi
from 91732
Norwalk, CT
Click here to add this to my saved trials
Oakland, California 94611
349
mi
from 91732
Oakland, CA
Click here to add this to my saved trials
Oakland Park, Florida 33309
2311
mi
from 91732
Oakland Park, FL
Click here to add this to my saved trials
Orlando, Florida 32806
2186
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
Plantation, Florida 33324
2308
mi
from 91732
Plantation, FL
Click here to add this to my saved trials
Portland, Maine 04101
2614
mi
from 91732
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97227
829
mi
from 91732
Portland, OR
Click here to add this to my saved trials
Saint Louis, Missouri 63110
1570
mi
from 91732
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94115
356
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials
Spokane, Washington 99208
947
mi
from 91732
Spokane, WA
Click here to add this to my saved trials
Tarzana, California 91356
31
mi
from 91732
Tarzana, CA
Click here to add this to my saved trials
Toronto, Ontario
2159
mi
from 91732
Toronto,
Click here to add this to my saved trials
Washington, District of Columbia 20007
2281
mi
from 91732
Washington,
Click here to add this to my saved trials
Wichita, Kansas 67207
1186
mi
from 91732
Wichita, KS
Click here to add this to my saved trials