An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients

Inclusion Criteria Patients must: Have HIV infection. Be asymptomatic (group 1) or have AIDS (group 2). Be able to understand and follow instructions. Concurrent Medication: Allowed: GROUP 2: Anti-HIV therapy. Systemic prophylaxis or maintenance therapy for any AIDS-defining opportunistic infection excluding agents considered immunomodulators or immunosuppressants. Topical nystatin. Clotrimazole troches. Acyclovir. Dapsone. Trimethoprim / sulfamethoxazole (T/S). Fluconazole. Ketoconazole. Aerosolized pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: ALL PATIENTS: Known hypersensitivity to disulfiram or diethyldithiocarbamate (DTC). Transfusion dependence. GROUP 1 PATIENTS ONLY: Oral candidiasis documented by morphology or by a response to antifungal therapy. Oral hairy leukoplakia. Occurrence of herpes zoster in a single dermatomal distribution. Recurrent seborrheic dermatitis. Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study. Unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30 days within 2 years of expected study entry. Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval. Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation. GROUP 2 PATIENTS ONLY: Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin. Diagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry. Concurrent Medication: Excluded: ALL PATIENTS: Recombinant erythropoietin. GROUP 1: Antiretroviral medications. GROUP 2: Immunomodulators or immunosuppressants. Concurrent Treatment: Excluded: Requirement for blood transfusions more than once a month. Patients with the following prior conditions are excluded: GROUP 1 PATIENTS ONLY: Oral candidiasis documented by morphology or by a response to antifungal therapy. Oral hairy leukoplakia. Occurrence of herpes zoster in a single dermatomal distribution. Recurrent seborrheic dermatitis. Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight within 2 years prior to study. Unexplained temperature above 38 degrees C on more than 5 consecutive days or on more than 10 days in any 30-day period within 2 years of expected study entry. Unexplained diarrhea defined by two or more stools/day for at least 14 days during a 120-day interval. Evidence of clinically significant cardiac, respiratory, hepatic, gastrointestinal, endocrine, hematologic, psychiatric, neurologic, renal, or dermatologic disease as demonstrated by history, physical, and laboratory evaluation. GROUP 2 PATIENTS ONLY: Diagnosis of an acute opportunistic infection within 3 weeks of study entry or had treatment initiated for an opportunistic infection within 3 weeks of study entry. Prior Medication: Excluded: ALL PATIENTS: Corticosteroids, cytotoxic agents, or immunomodulating agents within 30 days prior to study entry. Chronic Antabuse (disulfiram) therapy. GROUP 1 ONLY: Antiretrovial medications within 1 week prior to study entry. Prior Treatment: Excluded: Transfusion within 7 days of study entry. Radiation therapy within 30 days prior to study entry. Unable to refrain from the use of alcohol for the duration of the study.