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

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.