A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Malignancy for which systemic chemotherapy is required.
• •Medically significant liver disease, orthostatic hypotension, hypertension, cardiac disease, seizure disorders, or lymphoma.
• •Any medical condition that would interfere with evaluation of the patient.
• •Concurrent Medication:
• •Excluded:
• •AZT, ddI, ddC, d4T, or any other antiretroviral medication.
• •Interferon or other immunomodulating drugs.
• •Cytotoxic chemotherapy.
• •Foscarnet.
• •Ganciclovir.
• •Antimycobacterial drugs other than rifabutin.
• •MAO inhibitors.
• •Hypertension-inducing, nephrotoxic, or hepatotoxic drugs.
• •Opiates.
• •Drugs known to cause photosensitivity.
• •Prior Medication:
• •Excluded within 1 month prior to study entry:
• •AZT, ddI, ddC, d4T, or any other antiretroviral medication.
• •Interferon or other immunomodulating drugs.
• •Cytotoxic chemotherapy.
• •Preparations known to contain hypericin.
• •Excluded within 3 months prior to study entry:
• •Ribavirin.
• •Hyperforate (500 mg tablets or ampules for IV injection) manufactured by Kline.
• •Psychotonin M Alcohol Extract manufactured by Steigerwald.
• •Hypericin (40 mg vial) by VIMRx.
• •Excluded within 14 days prior to study entry:
• •Foscarnet.
• •Ganciclovir.
• •Antimycobacterial drugs other than rifabutin.
• •MAO inhibitors.
• •Hypertension-inducing, nephrotoxic, or hepatotoxic drugs.