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HIV InfectionsNCT00000650

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

A study testing Ditiocarb sodium in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
HIV Infections
What is being tested?
Ditiocarb sodium
How many people
12 participants
Where
1 siteUnited States
Study dates
Start not givento Sep 1996
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients must:
  • Have HIV infection.
  • Be asymptomatic (group 1) or have AIDS (group 2).
  • Be able to understand and follow instructions.
  • Concurrent Medication:
  • Allowed:
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  • 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.

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

Other trials in United States

About this study

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.

Read the 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
Being tested
Ditiocarb sodium
Keywords
Drug Evaluation, Ditiocarb, Acquired Immunodeficiency Syndrome
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ditiocarb sodiumDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionSep 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Masking
None (open label)
Enrolment
12 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000650
Sponsor's protocol ID
ACTG 166
Other IDs
11141
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
27 Oct 2021
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Ditiocarb sodium in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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