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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: | NCT00000645 |
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 virological and immunological surrogate markers of HIV infection. To determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol solution.
Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Hypericin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes |
Estimated Enrollment: | 32 |
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. NOTE: The initial study was stopped secondary to an MTD being reached.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
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.
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Active substance abuse.
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 ID Numbers: | ACTG 150 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000645 |
Health Authority: | Unspecified |
Drug Evaluation 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 |