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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT00001995
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Zidovudine (AZT).
* Didanosine (ddI).
Patients must have the following:
* Diagnosis of AIDS as defined by the CDC.
* Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
* Provide written informed consent.
Prior Medication:
Allowed:
* If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
* Required:
* Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Known hypersensitivity to any of the study drugs.
Concurrent Medication:
Excluded:
* Other therapy for mycobacterial disease.
Patients with the following are excluded:
* Known hypersensitivity to any of the study drugs.
Prior Medication:
Excluded within 4 weeks:
* Therapy for mycobacterial disease.
* Antiretroviral drugs, other than zidovudine (AZT) or ddI.
* Investigational drugs, other than ddI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00001995
Study Brief:
Protocol Section:
NCT00001995