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:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT00002058
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Pneumocystis prophylaxis.
* Antiretroviral therapy, or other experimental protocols.
* Antipyretics and analgesics as per the treating physician.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Unexplained fever.
* Night sweats.
* Unexplained anemia with hemoglobin \< 10 g percent or hematocrit less than 30 percent.
* Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
* Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.
Patients with the following are excluded:
* Known hypersensitivity to clofazimine.
* Mycobacterium avium complex (MAC) infection diagnosis at any site (except isolation from stool in asymptomatic patient).
* Any of the following symptoms at the time of study entry:
* Unexplained fever.
* Night sweats.
* Unexplained anemia with hemoglobin \< 10 percent or hematocrit less than 30 percent.
* Hepatic transaminase elevations or total bilirubin values of \> 3 times normal.
* Long-term (over 2 weeks) treatment with any drug with known significant anti-MAC activity.
Prior Medication:
Excluded:
* Long-term (over 2 weeks) treatment with any drug with known significant anti-Mycobacterium avium complex (MAC) activity including isoniazid, ethambutol, rifampin, raffia, PAS, PZA, amikacin, streptomycin, ethionamide, viomycin, cycloserine, capreomycin, ciprofloxacin, imipenem, rifapentine, gentamicin, or penicillin.
Group 1:
* AIDS patients with a first episode of Pneumocystis carinii pneumonia (PCP) within 2 to 4 months prior to study entry.
* Group 2:
* Patients with T4 counts \< 100 cells/mm3, regardless of prior opportunistic infections or malignancies.
* Karnofsky = or \> 70.
* All patients must sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002058
Study Brief:
Protocol Section:
NCT00002058