A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Hypericin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hypericin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Evaluation, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Antiviral Agents