A Study to Evaluate 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
- Conditions
- HIV Infections
- Registration Number
- NCT00002243
- Lead Sponsor
- Sarawak MediChem Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
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
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
South Florida Bioavailability Clinic🇺🇸Miami, Florida, United States