Status:
COMPLETED
A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
VIMRx Pharmaceuticals
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine the maximum tolerated dose (MTD) of hypericin, to define the types of toxicities that may be observed, and to determine what doses of the drug are associated with improvements in virologi...
Detailed Description
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 hyperici...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
October 1 1994
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00000645
End Date
October 1 1994
Last Update
November 3 2021
Active Locations (3)
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1
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
2
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
3
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016