Screening Protocol To Determine Eligibility For Studies Of The Chemokine Coreceptor 5 (CCR5) Antagonist GW873140

HIV Infection Clinical Trial

Official title:

A Screening Protocol to Determine Eligibility for One of Three Phase III Treatment Studies Evaluating the Efficacy and Safety of GW873140 in R5-tropic and R5/X4-tropic HIV-1 Infected, Treatment-experienced Subjects With Drug-resistant Virus or an Observational Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00123890
• Other study ID #: CCR104627
• Status: Terminated
• Phase: Phase 3
• First received: July 22, 2005
• Last updated: March 28, 2011
• Start date: June 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 AdministrationDenmark: Danish Medicines AgencyBelgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine eligibility for one of three treatment studies of the CCR5 antagonist GW873140 or an observational study without GW873140. No investigational treatment will be administered through this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• 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.

• 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.

• Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment or observational studies.

• 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

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• GW873140

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Bruxelles
Belgium	GSK Investigational Site	Charleroi
Canada	GSK Investigational Site	Toronto	Ontario
Denmark	GSK Investigational Site	Koebenhavn
Germany	GSK Investigational Site	Duesseldorf	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	East Orange	New Jersey
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Glastonbury	Connecticut
United States	GSK Investigational Site	Hampton	Virginia
United States	GSK Investigational Site	Hollywood	Florida
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Laguna Beach	California
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Lynchburg	Virginia
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Norwalk	Connecticut
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Oakland Park	Florida
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tarzana	California
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of subject eligibility for CCR102709, CCR104456, CCR104458, or CCR104629.			Yes