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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000792
First Posted: August 31, 2001
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VIMRx Pharmaceuticals
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose

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 daily oral hypericin.

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.


Condition Intervention Phase
HIV Infections Drug: Hypericin Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
Study Completion Date: January 1995
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 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 patients at a given dose have completed 3 weeks of therapy without evidence of dose-limiting toxicity, data will be reviewed to determine whether subsequent patients should be entered at the next higher dose. The MTD is defined as the dose level immediately below that at which grade 3 or worse toxicity is seen in three or more of six patients.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000792


Locations
United States, Maryland
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, United States, 02215
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
VIMRx Pharmaceuticals
Investigators
Study Chair: Valentine FT
Study Chair: Crumpacker C
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000792     History of Changes
Other Study ID Numbers: ACTG 258
11235 ( Registry Identifier: DAIDS ES Registry Number )
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Administration, Oral
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hypericin
Antidepressive Agents
Psychotropic Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs