Study Stopped
The study was terminated due to hepatoxicity of compound
Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140
A Screening Protocol to Determine Eligibility for One of Three Phase III Treatment Studies Evaluating the Efficacy and Safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 Infected, Treatment-experienced Subjects With Drug-resistant Virus or an Observational Study.
1 other identifier
interventional
N/A
5 countries
42
Brief Summary
The purpose of this study is to determine eligibility for one of three treatment studies of the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational treatment will be administered through this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2005
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 22, 2005
CompletedFirst Posted
Study publicly available on registry
July 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedMarch 29, 2011
March 1, 2011
4 months
July 22, 2005
March 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.
Interventions
Eligibility Criteria
You may qualify if:
- HIV-infected.
- Screening viral load at least 5000copies/mL.
- 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.
You may not qualify if:
- 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.
- Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment or observational studies.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Laguna Beach, California, 92651, United States
GSK Investigational Site
Long Beach, California, 90813, United States
GSK Investigational Site
Los Angeles, California, 90046, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
Tarzana, California, 30342, United States
GSK Investigational Site
Glastonbury, Connecticut, 06033, United States
GSK Investigational Site
Norwalk, Connecticut, 06851, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20009, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33308, United States
GSK Investigational Site
Hollywood, Florida, 33020, United States
GSK Investigational Site
Oakland Park, Florida, 33334, United States
GSK Investigational Site
Orlando, Florida, 32804, United States
GSK Investigational Site
Plantation, Florida, 33317, United States
GSK Investigational Site
Tampa, Florida, 33607, United States
GSK Investigational Site
Atlanta, Georgia, 30339, United States
GSK Investigational Site
Chicago, Illinois, 60657, United States
GSK Investigational Site
New Orleans, Louisiana, 70127-0800, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Minneapolis, Minnesota, 55404, United States
GSK Investigational Site
Las Vegas, Nevada, 89102, United States
GSK Investigational Site
East Orange, New Jersey, 07018, United States
GSK Investigational Site
Newark, New Jersey, 07102, United States
GSK Investigational Site
New York, New York, 10014, United States
GSK Investigational Site
Akron, Ohio, 44304, United States
GSK Investigational Site
Portland, Oregon, 97209, United States
GSK Investigational Site
Portland, Oregon, 97219, United States
GSK Investigational Site
Austin, Texas, 78746, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77027, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Lynchburg, Virginia, 24501, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Brussels, 1000, Belgium
GSK Investigational Site
Charleroi, 6000, Belgium
GSK Investigational Site
Toronto, Ontario, M5B 1L6, Canada
GSK Investigational Site
Copenhagen, DK-2100, Denmark
GSK Investigational Site
Hamburg, Hamburg, 20099, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50937, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, Ph.D.
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 22, 2005
First Posted
July 26, 2005
Study Start
June 1, 2005
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
March 29, 2011
Record last verified: 2011-03