The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.
Bevirimat (PA103001-04) represents a new class of antivirals that blocks HIV replication by disrupting virus maturation; specifically, by inhibiting a late step in the Gag processing cascade. Short term (7-10 days) functional monotherapy studies (conducted in patients with detectable viral loads on a failing regimen)help in determining the potency of the drug, and enable dose finding. This is a two part (A and B)randomized, placebo-controlled, double-blind, multiple-dose, dose-escalation study in HIV treatment-experienced patients on a failing regimen (harboring resistance mutations to at least one member of the NRTI, NNRTI or PI classes. The antiretroviral activity, safety, and pharmacokinetics of up to 5 different dose levels of bevirimat will be compared to placebo when added to a failing approved antiretroviral regimen. The study is conducted in two parts: A and B. In Part A following 14 days of daily dosing patients commenced a new optimized ART regimen in addition to their randomized treatment. In Part Part B dosing with the randomized treatment ends after the initial 14 days of daily dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
92
UCLA Medical Center
Los Angeles, California, United States
Quest Clinical Research
San Francisco, California, United States
HIV-1 RNA change from baseline over the first 14 days of study
Time frame: 14 days
safety and tolerability; pharmacokinetics
Time frame: 14 days
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University of Colorado Health Science Center
Denver, Colorado, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States
Gary Richmond
Fort Lauderdale, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
The Research Insitute
Boston, Massachusetts, United States
...and 8 more locations