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

This study has been terminated.
(The study was terminated due to hepatoxicity of compound)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00123890
First received: July 22, 2005
Last updated: March 28, 2011
Last verified: March 2011

July 22, 2005
March 28, 2011
June 2005
October 2005   (final data collection date for primary outcome measure)
Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629. [ Designated as safety issue: Yes ]
Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.
Complete list of historical versions of study NCT00123890 on ClinicalTrials.gov Archive Site
Not Provided
No secondary outcomes
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Diagnostic
HIV Infection
Drug: GW873140
Other Name: GW873140
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   Germany
 
NCT00123890
CCR104627
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, Ph.D. GlaxoSmithKline
GlaxoSmithKline
March 2011

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