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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Connaught Laboratories |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000650 |
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 |
MedlinePlus related topics: | AIDS |
Drug Information available for: | 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 |
Estimated Enrollment: | 12 |
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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must:
Concurrent Medication:
Allowed:
GROUP 2:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
ALL PATIENTS:
GROUP 1 PATIENTS ONLY:
GROUP 2 PATIENTS ONLY:
Concurrent Medication:
Excluded:
ALL PATIENTS:
GROUP 1:
GROUP 2:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
GROUP 1 PATIENTS ONLY:
GROUP 2 PATIENTS ONLY:
Prior Medication:
Excluded:
ALL PATIENTS:
GROUP 1 ONLY:
Prior Treatment:
Excluded:
Unable to refrain from the use of alcohol for the duration of the study.
United States, Maryland | |||||
Johns Hopkins Hosp | |||||
Baltimore, Maryland, United States, 21287 |
National Institute of Allergy and Infectious Diseases (NIAID) |
Connaught Laboratories |
Study Chair: | PS Lietman | |
Study Chair: | P Barditch-Crovo |
Study ID Numbers: | ACTG 166 |
First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000650 |
Health Authority: | United States: Federal Government |
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