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

NCT ID: NCT00000650

Last Updated: 2021-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1996-09-30

Brief 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.

Detailed Description

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.

Two groups of patients, one group asymptomatic and the other with AIDS diagnosis, are enrolled in the study. All patients receive DTC intravenously once a week for two weeks. Drugs are given on days 1 and 8. Blood samples are drawn on days 1, 3, 5, 8, 10, and 12.

Conditions

HIV Infections

Keywords

Drug Evaluation; Ditiocarb; Acquired Immunodeficiency Syndrome

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Ditiocarb sodium

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Connaught Laboratories

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

PS Lietman

Role: STUDY_CHAIR

P Barditch-Crovo

Role: STUDY_CHAIR

Locations

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

11141

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 166

Identifier Type: -

Identifier Source: org_study_id