Search / Trial NCT00000792

A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of November 28, 2023

Completed

Keywords

Administration, Oral Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents

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 should produce a trough level in a desired range without excessive peak levels. Cohorts of six patients each receive escalating doses of oral hypericin daily. Blood is sampled for peak and trough levels the second week of therapy. A computer modeling algorithm will use these levels to determine the appropriate dose needed for each patient to achieve the desired trough level. When three of six pati...

Gender

All

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.

Attachments

readout_NCT00000792_2023-11-28.pdf

4.5 MB

NCT00000792_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Baltimore, Maryland, United States

Boston, Massachusetts, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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