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

Launched by SARAWAK MEDICHEM PHARMACEUTICALS · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• You may be eligible for this study if you:
• • Are HIV-positive.
• • Have a CD4 count of at least 250 cells/mm3.
• • Have an HIV count (viral load) of at least 5,000 copies/ml.
• • Are at least 18 years old.
• • Exclusion Criteria
• You will not be eligible for this study if you:
• • Have received prescription or nonprescription medications within 14 days of study entry, or if you will need to take any of these medications during the study.
• • Have ever received anti-HIV medications.
• • Test positive for hepatitis B.
• • Have received a blood (or red blood cell) transfusion within 3 months prior to study entry.
• • Have severe diarrhea.
• • Have severe heart, liver, kidney, or neurological (brain and spinal cord) disease.
• • Have hemophilia or another blood disorder.
• • Have received certain medications or vaccines within 30 days prior to study entry.
• • Have received chemotherapy or radiation within 16 days prior to study entry, or if you will need either of these during the study.