Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00123890
Recruitment Status : Terminated (The study was terminated due to hepatoxicity of compound)
First Posted : July 26, 2005
Last Update Posted : March 29, 2011
Information provided by:

July 22, 2005
July 26, 2005
March 29, 2011
June 2005
October 2005   (Final data collection date for primary outcome measure)
Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.
Same as current
Complete list of historical versions of study NCT00123890 on Archive Site
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No secondary outcomes
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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.
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.
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Phase 3
Masking: None (Open Label)
Primary Purpose: Diagnostic
HIV Infection
Drug: GW873140
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2005
October 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

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.
  • 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   Germany,   United States
Argentina,   Australia,   Austria,   Chile,   France,   Greece,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Portugal,   Puerto Rico,   Romania,   South Africa,   Spain,   Thailand,   United Kingdom
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Study Director, GSK
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Study Director: GSK Clinical Trials, Ph.D. GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP