A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
Hypericin
Infecciones Transmitidas por la Sangre+13
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Tratamiento
Resumen
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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 32 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Beth Israel Deaconess - East Campus A0102 CRS
Boston, United StatesAbrir Beth Israel Deaconess - East Campus A0102 CRS en Google MapsUniversity of Minnesota, ACTU
Minneapolis, United StatesNY Univ. HIV/AIDS CRS
New York, United States