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

HIV Infection Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00197197
• Other study ID #: CCR104458
• Status: Terminated
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 28, 2011
• Start date: July 2005
• Est. completion date: October 2005

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• GW873140

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Norwalk	Connecticut
United States	GSK Investigational Site	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV viral load response at 24 and 48 weeks.		24 and 48 weeks	Yes
Secondary	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	Yes