Expired Study
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Los Angeles, California 90012


Purpose:

To examine the safety and tolerance of three doses of oral vesnarinone in HIV-infected patients with CD4 count > 300 cells/mm3.


Study summary:

Twelve patients per dose level receive vesnarinone at 1 of 3 doses for 12 weeks. At least six patients at a given dose level must have completed 2 weeks of treatment before dose is escalated in subsequent patients.


Criteria:

Inclusion Criteria Concurrent Medication: Allowed: - Chemoprophylaxis for Pneumocystis carinii, candida, mycobacteria, and herpes simplex. Patients must have: - Asymptomatic HIV infection. - CD4 count > 300 cells/mm3. - No prior AIDS-defining illness or current constitutional symptoms of HIV disease. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Current history of cardiac disease, including patients who exhibit long QT syndrome on EKG screening. - Active malignancy other than cutaneous basal cell carcinoma or in situ carcinoma of the cervix. Concurrent Medication: Excluded: - Antiretroviral agents, including ddI, ddC, and AZT. - Immunosuppressive agents. - Investigational HIV drugs/therapies including vaccines. - Interferon. - Steroids (other than topical). - Hematopoietins. - Megestrol acetate. - Trimethoprim/sulfamethoxazole in excess of 160 mg trimethoprim and 800 mg sulfamethoxazole thrice weekly. - Cytotoxic chemotherapy. Concurrent Treatment: Excluded: - Radiation therapy. Patients with the following prior conditions are excluded: - Prior history of cardiac disease. - History of agranulocytosis or severe (grade 3) drug-induced neutropenia or documented abnormalities in granulocyte number or function. Prior Medication: Excluded: - AZT, ddI, and ddC within 14 days prior to study entry. - Prior cytotoxic chemotherapy. Prior Treatment: Excluded: - Radiation therapy (including electron beam irradiation) within 30 days prior to study entry. Active illicit drug abuse.


NCT ID:

NCT00002129


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90012
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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