Search / Trial NCT00000650

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Drug Evaluation Ditiocarb Acquired Immunodeficiency Syndrome

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.

Gender

All

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.

Attachments

readout_NCT00000650_2024-03-02.pdf

4.5 MB

NCT00000650_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Baltimore, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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