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Trial NCT00000645

Resource URI: http://static.linkedct.org/resource/trials/NCT00000645
PropertyValue
linkedct:brief_title A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5445>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria 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.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 32 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000645
rdfs:label Trial NCT00000645
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency VIMRx Pharmaceuticals
linkedct:location <http://static.linkedct.org/resource/location/148178>
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:nct_id NCT00000645
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes
linkedct:org_study_id ACTG 150
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/59890>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/3038>
foaf:page <http://clinicaltrials.gov/show/NCT00000645>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/1474>
linkedct:reference <http://static.linkedct.org/resource/reference/2359>
linkedct:reference <http://static.linkedct.org/resource/reference/3923>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Open Label
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date February 1995