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

Pfizer

Status and phase

Completed

Phase 2

Conditions

Human Immunodeficiency Virus

Treatments

Drug: Capravirine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00051844

A4311002

Details and patient eligibility

About

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.

Enrollment

179 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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