A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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 virological and immunological surrogate markers of HIV infection. To determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol solution. Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.
Key facts
- Study ID
- NCT00000645
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 32
- Expected to finish
- 1994-10-01
- Last updated by the study team
- 2021-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
- University of Minnesota, ACTU — Minneapolis, Minnesota, United States
- NY Univ. HIV/AIDS CRS — New York, New York, United States
Full record on ClinicalTrials.gov
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