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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarawak MediChem Pharmaceuticals
• Treatments: Calanolide A; Reverse Transcriptase Inhibitors

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.