Status:
COMPLETED
A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects
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 safety and tolerance of daily oral hypericin when given to achieve target trough levels within defined cohorts. To determine the responses of surrogate markers of HIV infection to dai...
Detailed Description
It is not known whether daily oral dosing will produce a tolerable prolonged exposure to therapeutic levels of hypericin. Pharmacokinetic modeling studies have demonstrated that daily oral dosing shou...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Required:
- PCP prophylaxis.
Allowed:
- Rifabutin, ketoconazole, fluconazole, and acyclovir, provided the medication has been taken for at least 4 weeks prior to study entry without toxicity.
- Topical medications such as clotrimazole troches or nystatin suspension.
Patients must have:
- Documented HIV infection.
- CD4 count <= 350 cells/mm3.
- p24 antigen positive at >= 35 pcg/ml.
- No active opportunistic infection at study entry that would require curative or suppressive therapy.
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 1995
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000792
End Date
January 1 1995
Last Update
November 4 2021
Active Locations (3)
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1
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
2
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
3
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016