The Safety and Effectiveness of (+)-Calanolide A in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

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

Summary

The purpose of this study is to see if it is safe and effective to give calanolide A to HIV-infected adults who have not used anti-HIV drugs in the past.

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

Details

• Lead Sponsor: Sarawak MediChem Pharmaceuticals
• Treatments: Calanolide A

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

• Are at least 18 years old.

• Agree to use effective methods of birth control during the study.

• Have a CD4 cell count of 200 cells/mm3 or more.

• Have HIV levels of 5000 copies/ml or more.

Exclusion Criteria

Patients will not be eligible for this study if they:

• Have abnormal blood tests.

• Have had a reaction to study medication.

• Have a history of opportunistic (AIDS-related) infection or cancer.

• Are being treated for active pulmonary tuberculosis.

• Have a fever of 39 degrees C or more within 14 days of beginning study treatment.

• Are unable to take medications by mouth.

• Have an abnormal chest X-ray or ECG within 30 days of beginning study treatment.

• Have hepatitis, hemophilia, or other blood disorder.

• Have significant heart, stomach, intestinal, liver, nerve, or kidney problems.

• Have a condition which may affect ability to participate in this study, such as drug or alcohol abuse or a serious mental disorder.

• Have taken anti-HIV drugs in the past.

• Are taking certain medications.

• Have had a blood transfusion within the 3 months prior to entering the study.

• Have had radiation or chemotherapy within 16 days before the screening visit or plan to receive such treatment during the study.

• Are pregnant or breast-feeding.