Clinical Drug Experience Knowledgebase

Criteria

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.