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

Sarawak MediChem Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: HIV Infections

Treatments: Drug: Calanolide A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00005120

57CL-0001

297B

Details and patient eligibility

About

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.

Full description

Patients are randomized to receive (+)-calanolide A or placebo for 21 days. All patients may elect to receive an open-label, 3-month course of approved retroviral therapy (up to triple-drug therapy) to be selected by, and administered under the care of, the patients' physicians. If the patient has no insurance coverage or does not wish to utilize his/her insurance for anti-HIV medications, Sarawak MediChem Pharmaceuticals will provide these medications at no charge for up to 3 months.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.