Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects

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: NCT00197197
Recruitment Status : Terminated (The study was terminated due to hepatoxicity of compound)
First Posted : September 20, 2005
Last Update Posted : March 29, 2011
Information provided by:

Brief Summary:
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/X4-tropic virus

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : July 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

Primary Outcome Measures :
  1. HIV viral load response at 24 and 48 weeks. [ Time Frame: 24 and 48 weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability, change in T-cell count, disease progression, viral resistance,tropism at failure, pharmacokinetics, health outcomes.Liver tests will be done every 2 weeks for 24 weeks. [ Time Frame: every 2 weeks for 24 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Inclusion criteria:

  • HIV-infected.
  • Screening viral load at least 5000copies/mL.
  • R5/X4-tropic virus at screening.
  • Total prior antiretroviral experience of at least 3 months.
  • 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-tropic only.
  • X4-tropic only.
  • 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.

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 identifier (NCT number): NCT00197197

United States, California
GSK Investigational Site
Los Angeles, California, United States, 90046
United States, Connecticut
GSK Investigational Site
Norwalk, Connecticut, United States, 06851
United States, Florida
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33308
GSK Investigational Site
Hollywood, Florida, United States, 33020
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, Texas
GSK Investigational Site
Houston, Texas, United States, 77027
GSK Investigational Site
Bruxelles, Belgium, 1000
Sponsors and Collaborators
Study Director: GSK Clinical Trials, Ph.D. GlaxoSmithKline

Responsible Party: Study Director, GSK Identifier: NCT00197197     History of Changes
Other Study ID Numbers: CCR104458
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 29, 2011
Last Verified: March 2011

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