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| ID | Type | Description | Link |
|---|---|---|---|
| 11125 | Registry Identifier | DAIDS ES Registry Number |
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| Name | Class |
|---|---|
| VIMRx Pharmaceuticals | INDUSTRY |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypericin | Drug |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Valentine FT | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess - East Campus A0102 CRS | Boston | Massachusetts | 02215 | United States | ||
| University of Minnesota, ACTU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Gulick R, Lui H, Anderson R, Kollias N, Hussey S, Crumpacker C. Human hypericism: a photosensitivity reaction to hypericin (St. John's Wort). Int Conf AIDS. 1992 Jul 19-24;8(2):B90 (abstract no PoB 3018) | ||
| Background | Mcauliffe V, et al. A phase I dose escalation study of synthetic hypericin in HIV infected patients (ACTG 150). Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:159 | ||
| 10075619 | Background | Gulick RM, McAuliffe V, Holden-Wiltse J, Crumpacker C, Liebes L, Stein DS, Meehan P, Hussey S, Forcht J, Valentine FT. Phase I studies of hypericin, the active compound in St. John's Wort, as an antiretroviral agent in HIV-infected adults. AIDS Clinical Trials Group Protocols 150 and 258. Ann Intern Med. 1999 Mar 16;130(6):510-4. doi: 10.7326/0003-4819-130-6-199903160-00015. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000386 | AIDS-Related Complex |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C004965 | hypericin |
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| Minneapolis |
| Minnesota |
| United States |
| NY Univ. HIV/AIDS CRS | New York | New York | 10016 | United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |