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An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator: Connaught Laboratories
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000650
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Ditiocarb sodium

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 12
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000650

Locations
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Connaught Laboratories
Investigators
Study Chair: PS Lietman
Study Chair: P Barditch-Crovo
  More Information

No publications provided

Study ID Numbers: ACTG 166
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000650     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Evaluation
Ditiocarb
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Ditiocarb
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Chelating Agents
Retroviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009