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

NCT00000650 | Completed

• 2 other identifiers: ACTG 16611141
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Drug Evaluation; Ditiocarb; Acquired Immunodeficiency Syndrome

Interventions

Ditiocarb sodium DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Connaught Laboratories: collaborator

Study Sites (1)

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Ditiocarb

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Sulfur Compounds

Study Officials

• PS Lietman

  STUDY CHAIR

• P Barditch-Crovo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1996
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

US (1)