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
Birmingham, Alabama 35249
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Akron, Ohio 44313
?
mi
from
Akron, OH
Click here to add this to my saved trials
Annandale, Virginia 22003
?
mi
from
Annandale, VA
Click here to add this to my saved trials
Atlanta, Georgia 30341
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Austin, Texas 78705
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Charlotte, North Carolina 28203
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Georgia 30033
?
mi
from
Decatur, GA
Click here to add this to my saved trials
East Orange, New Jersey
?
mi
from
East Orange, NJ
Click here to add this to my saved trials
Fort Lauderdale, Florida 33308
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Myers, Florida 33916
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
Glastonbury, Connecticut 06033
?
mi
from
Glastonbury, CT
Click here to add this to my saved trials
Hampton, Virginia 23666
?
mi
from
Hampton, VA
Click here to add this to my saved trials
Hillsborough, New Jersey 08844
?
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Key West, Florida 33040
?
mi
from
Key West, FL
Click here to add this to my saved trials
Laguna Beach, California 90803
?
mi
from
Laguna Beach, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89102
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Long Beach, California 90813
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90025
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Miami, Florida 33136
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mount Vernon, New York 10550
?
mi
from
Mount Vernon, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10032
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07112
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Norwalk, Connecticut 06850
?
mi
from
Norwalk, CT
Click here to add this to my saved trials
Oakland, California 94611
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Oakland Park, Florida 33309
?
mi
from
Oakland Park, FL
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Plantation, Florida 33324
?
mi
from
Plantation, FL
Click here to add this to my saved trials
Portland, Maine 04101
?
mi
from
Portland, ME
Click here to add this to my saved trials
Portland, Oregon 97227
?
mi
from
Portland, OR
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94115
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Spokane, Washington 99208
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Tarzana, California 91356
?
mi
from
Tarzana, CA
Click here to add this to my saved trials
Toronto, Ontario
?
mi
from
Toronto,
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
Wichita, Kansas 67207
?
mi
from
Wichita, KS
Click here to add this to my saved trials