Search / Trial NCT00000645

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

Trial Information

Current as of December 05, 2024

Completed

Keywords

Drug Evaluation Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

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.

Trial Officials

Valentine FT

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Boston, Massachusetts, United States

Minneapolis, Minnesota, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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