Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT00000650
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00000650
Study Brief:
Protocol Section:
NCT00000650