Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen

Completed · Phase 2

Conditions studied: Human Immunodeficiency Virus

In brief

This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

Key facts

Study ID

NCT00051844

Run by

Pfizer

People needed

179

Starts

2002-08-01

Expected to finish

2004-11-01

Last updated by the study team

2011-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female at least 18 years old
• HIV RNA level >1000 copies/mL at screening
• CD4 >50 cells/uL at screening
• Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
• Patient has adequate hematology tests (absolute neutrophil count >1000/uL, Platelets>75,000uL, hemoglobin 9g/L)
• Patient has adequate renal function (serum creatinine of <1.5 upper limit of normal)
• Patient has adequate liver function (AST, ALT, and bilirubin < 2.5 upper limit of normal)

You may not qualify if…

• Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was <50 copies) This exception does not include Viracept
• Women who are pregnant or lactating

Where it is running

• Pfizer Investigational Site — Long Beach, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — West Hollywood, California, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Safety Harbor, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Jonesboro, Georgia, United States
• Pfizer Investigational Site — Tucker, Georgia, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Wichita, Kansas, United States
• Pfizer Investigational Site — Jackson, Mississippi, United States
• Pfizer Investigational Site — Brooklyn, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Stony Brook, New York, United States
• Pfizer Investigational Site — Huntersville, North Carolina, United States
• Pfizer Investigational Site — Winston-Salem, North Carolina, United States
• Pfizer Investigational Site — Akron, Ohio, United States
• Pfizer Investigational Site — Cincinnati, Ohio, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Portland, Oregon, United States
• Pfizer Investigational Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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