The purpose of this study is to test the safety and effectiveness of a new non-nucleoside reverse transcriptase inhibitor (NNRTI), (+)-calanolide A, in HIV-positive patients who have never received anti-HIV treatment.
Patients are randomized into 2 cohorts, with Cohort 2 receiving a higher dosage than Cohort 1. Patients in each cohort receive either (+)-calanolide A or a placebo for 14 days, followed by a 14-day follow-up period. Following study treatment, patients may elect to receive an open-label, 6-month course of anti-HIV drugs to be selected by and administered under the care of the patient's physician.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
South Florida Bioavailability Clinic
Miami, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
Cook County Hosp
Chicago, Illinois, United States
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Univ of Maryland Institute of Human Virology
Baltimore, Maryland, United States
Boston Med Ctr / Clinical Research Office
Boston, Massachusetts, United States
Beth Israel Med Ctr
New York, New York, United States
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Univ of Texas / Med Branch at Galveston
Galveston, Texas, United States