A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.

Each group of eight patients receives a given dose of hypericin by intravenous infusion. Doses are given three times per week for 8 weeks. When all eight patients at a dose level have been entered and four of the eight patients have completed 3 weeks of therapy without evidence of dose-limiting toxicity, additional patients may begin to receive drug at the next dose level. Concurrently, six patients wll participate in an oral-dosing bioavailability study....

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Prophylaxis for Pneumocystis carinii pneumonia (required for patients with CD4+ \< 200).
• • Symptomatic treatment with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy.
• • Short courses (\< 10 days) with ketoconazole or fluconazole for oral candidiasis or acyclovir for herpes lesions.
• • Topical medications such as clotrimazole troches or nystatin suspensions.
• Concurrent Treatment:
• Allowed:
• • Blood transfusions.
• • Patients must have HIV infection with CD+4 lymphocyte count of \< 300 cells/mm3.
• • Exclusion Criteria
• Co-existing Condition:
• • Patients with the following conditions or symptoms are excluded.
• • Kaposi's sarcoma requiring systemic therapy.
• Concurrent Medication:
• Excluded:
• • Continued use of opiates or drugs known to induce photosensitivity.
• Patients with the following are excluded:
• • Active or chronic opportunistic infection at time of study entry that required curative or suppressive therapy.
• • Significant liver disease, orthostatic hypotension, cardiac disease, seizure disorder, lymphoma, hypotension.
• Prior Medication:
• Excluded:
• • Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), interferon, other antiretroviral agents or immunomodulating drugs within 1 month prior to study entry. Ribavirin within 3 months of study entry.
• • Ganciclovir (DHPG), antimycobacterial drugs, MAO inhibitors, hypertension-inducing, nephrotoxic, or hepatotoxic drugs within 14 days of entry.
• • Cytotoxic chemotherapy within 1 month prior to study entry.
• • Active substance abuse.