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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Page 1 of 1 (3 locations)

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

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