Completed

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

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What is being tested

Ditiocarb sodium

Drug
Who is being recruted

HIV Infections

From 18 to 50 Years
How is the trial designed

Treatment Study

Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 27, 2021
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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. 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.

Official TitleAn Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 27, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
12 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Johns Hopkins Adult AIDS CRSBaltimore, United StatesSee the location

CompletedOne Study Center