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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 3

Conditions: HIV Infection

Treatments: Drug: GW873140

Study type: Interventional

Funder types: Industry

Identifiers

NCT00123890

CCR104627

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.