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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00002267
Eligibility Criteria:
Inclusion Criteria
Patients must have the following:
* Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
* Written informed consent obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
* Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.
Concurrent Medication:
Excluded:
* Antiretroviral agents other than zidovudine (AZT).
* Didanosine (ddI).
* Antimycobacterial therapy.
* Rifampin.
* Isoniazid.
* Clofazimine.
* Ethambutol.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.
* Streptomycin.
* Other investigational drugs.
* If antimicrobial therapy is required to treat bacterial infections (= or \< 14 days), Adria Laboratories must be contacted prior to initiation of therapy.
Patients with the following are excluded:
* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
* Previous or current Mycobacterium avium complex (MAC) infection.
* Perceived patient unreliability or unavailability for frequent monitoring.
Prior Medication:
Excluded within 4 weeks of study entry:
* Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
* Antimycobacterial therapy.
* Rifampin.
* Isoniazid.
* Clofazimine.
* Ethambutol.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.
Required:
* Zidovudine (AZT).
* Antipneumocystis prophylactic therapy.
Required for at least 4 weeks prior to study entry:
* Zidovudine (AZT) or didanosine (ddI).
* Antipneumocystis prophylaxis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002267
Study Brief:
Protocol Section:
NCT00002267