Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-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/X4-tropic virus

Study Overview

• Status: Terminated
• Conditions: HIV Infection
• Intervention / Treatment: Drug: GW873140

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1000
    • GSK Investigational Site
• United States
  • California
    • Los Angeles, California, United States, 90046
      • GSK Investigational Site
  • Connecticut
    • Norwalk, Connecticut, United States, 06851
      • GSK Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • GSK Investigational Site
    • Hollywood, Florida, United States, 33020
      • GSK Investigational Site
    • Plantation, Florida, United States, 33317
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60657
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70127-0800
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77027
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV viral load response at 24 and 48 weeks.	24 and 48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	every 2 weeks for 24 weeks

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, Ph.D., GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: HIV-1 GW873140 CCR5 antagonist treatment experienced
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Aplaviroc
• Other Study ID Numbers: CCR104458