A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
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| ClinicalTrials.gov Identifier: NCT00000645 |
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Recruitment Status :
Completed
First Posted : August 31, 2001
Last Update Posted : November 3, 2021
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Hypericin | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 32 participants |
| Masking: | None (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 |
| Actual Study Completion Date : | October 1994 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Prophylaxis for Pneumocystis carinii pneumonia (required for patients with CD4+ < 200).
- Symptomatic treatment with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy.
- Short courses (< 10 days) with ketoconazole or fluconazole for oral candidiasis or acyclovir for herpes lesions.
- Topical medications such as clotrimazole troches or nystatin suspensions.
Concurrent Treatment:
Allowed:
- Blood transfusions.
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.
- Kaposi's sarcoma requiring systemic therapy.
Concurrent Medication:
Excluded:
- Continued use of opiates or drugs known to induce photosensitivity.
Patients with the following are excluded:
- Active or chronic opportunistic infection at time of study entry that required curative or suppressive therapy.
- Significant liver disease, orthostatic hypotension, cardiac disease, seizure disorder, lymphoma, hypotension.
Prior Medication:
Excluded:
- Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), interferon, other antiretroviral agents or immunomodulating drugs within 1 month prior to study entry. Ribavirin within 3 months of study entry.
- Ganciclovir (DHPG), antimycobacterial drugs, MAO inhibitors, hypertension-inducing, nephrotoxic, or hepatotoxic drugs within 14 days of entry.
- Cytotoxic chemotherapy within 1 month prior to study entry.
Active substance abuse.
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): NCT00000645
| United States, Massachusetts | |
| Beth Israel Deaconess - East Campus A0102 CRS | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| University of Minnesota, ACTU | |
| Minneapolis, Minnesota, United States | |
| United States, New York | |
| NY Univ. HIV/AIDS CRS | |
| New York, New York, United States, 10016 | |
| Study Chair: | Valentine FT |
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000645 |
| Other Study ID Numbers: |
ACTG 150 11125 ( Registry Identifier: DAIDS ES Registry Number ) |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | November 3, 2021 |
| Last Verified: | October 2021 |
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Drug Evaluation Acquired Immunodeficiency Syndrome AIDS-Related Complex Antiviral Agents |
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HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Genital Diseases Urogenital 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 |