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NCT00123890 Clinical Trial

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
Secondary ID
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

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
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