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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infection Drug: GW873140 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Study Start Date : June 2005
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123890


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, Ph.D. GlaxoSmithKline
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00123890     History of Changes
Other Study ID Numbers: CCR104627
First Posted: July 26, 2005    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011

Keywords provided by GlaxoSmithKline:
HIV-1 GW873140 CCR5 antagonist experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases