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
  Purpose

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


Condition Intervention Phase
HIV Infection
Drug: GW873140
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: July 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW873140
    Other Name: GW873140
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00197145

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35294
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90046
GSK Investigational Site
Oakland, California, United States, 94609
GSK Investigational Site
Tarzana, California, United States, 30342
United States, Connecticut
GSK Investigational Site
Glastonbury, Connecticut, United States, 06033
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33306
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Plantation, Florida, United States, 33317
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30339
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
United States, Louisiana
GSK Investigational Site
New Orleans, Louisiana, United States, 70127-0800
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21201
United States, New Jersey
GSK Investigational Site
Newark, New Jersey, United States, 07102
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M5B 1L6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, Ph.D. GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00197145     History of Changes
Other Study ID Numbers: CCR102709
Study First Received: September 13, 2005
Last Updated: March 28, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 20, 2014