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

• Status: Completed
• Trial end date: 1996-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine, in HIV-infected patients, the magnitude and duration of the biological effects of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of HIV infection.

DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Connaught Laboratories
• Treatments: Ditiocarb

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.