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| Sponsor: | VIMRx Pharmaceuticals |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000645 |
Purpose
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 |
|---|---|---|
|
HIV Infections |
Drug: Hypericin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| 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.
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00000645 History of Changes |
| Other Study ID Numbers: | ACTG 150 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | Unspecified |
|
Drug Evaluation Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Hypericin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |