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

Primary Purpose

HIV Infection

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GW873140
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infection focused on measuring HIV-1 GW873140 CCR5 antagonist treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

HIV viral load response at 24 and 48 weeks.

Secondary Outcome Measures

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.

Full Information

First Posted
September 12, 2005
Last Updated
March 28, 2011
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00197197
Brief Title
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to hepatoxicity of compound
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection
Keywords
HIV-1 GW873140 CCR5 antagonist treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW873140
Primary Outcome Measure Information:
Title
HIV viral load response at 24 and 48 weeks.
Time Frame
24 and 48 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, Ph.D.
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90046
Country
United States
Facility Name
GSK Investigational Site
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
GSK Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
GSK Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
GSK Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33317
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70127-0800
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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