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Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects

This study has been terminated.
(The study was terminated due to hepatoxicity of compound)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197145
First received: September 13, 2005
Last updated: March 28, 2011
Last verified: March 2011

September 13, 2005
March 28, 2011
July 2005
October 2005   (final data collection date for primary outcome measure)
HIV viral load response at 24 and 48 weeks as measured by proportion of subjects with undetectable viral load, change from baseline over time, proportion of subjects with 1.0 log drop, and time to virologic failure. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
HIV viral load response at 24 and 48 weeks as measured by proportion of subjects with undetectable viral load, change from baseline over time, proportion of subjects with 1.0 log drop, and time to virologic failure.
Complete list of historical versions of study NCT00197145 on ClinicalTrials.gov Archive Site
Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes, and adherence will be determined over 24 and 48 weeks. Liver tests will be done every 2 weeks for 24 weeks. [ Time Frame: 24 and 48 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes, and adherence will be determined over 24 and 48 weeks.
Not Provided
Not Provided
 
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5-Tropic Treatment-Experienced HIV-Infected Subjects
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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
23
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00197145
CCR102709
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