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Sponsors and Collaborators: |
VIMRx Pharmaceuticals National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000792 |
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 |
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HIV Infections |
Drug: Hypericin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | A Pharmacologically Guided Phase I/II Study of Daily Orally Administered Synthetic Hypericin in HIV-Infected Subjects |
Estimated Enrollment: | 24 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 1 month prior to study entry:
Excluded within 3 months prior to study entry:
Excluded within 14 days prior to study entry:
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Beth Israel Deaconess Med Ctr | |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 |
Study Chair: | Valentine FT | |
Study Chair: | Crumpacker C |
Study ID Numbers: | ACTG 258 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000792 |
Health Authority: | Unspecified |
Administration, Oral Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Hypericin Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Enzyme Inhibitors |
Infection Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses Lentivirus Infections Central Nervous System Agents Antidepressive Agents |