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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00000860
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry.
Patients must have:
* Documented HIV infection.
* Either symptomatic MAC disease as defined by a history of clinical signs and symptoms, plus one blood culture positive for MAC or AFB obtained within the previous 90 days, OR asymptomatic MAC disease as defined by 2 blood cultures positive for MAC or AFB obtained within 90 days of entry.
* Signed parental consent for patients less than 18 years of age.
Prior Medication:
Allowed:
* Patients who have received presumptive or empiric antimycobacterial therapy prior to study entry may be enrolled if they have been treated for no more than 72 hours prior to study entry.
* Patients who have been receiving prophylaxis with azithromycin, clarithromycin and/or rifabutin may be enrolled.
* Patients should have successfully completed therapy or be on stable therapy for any acute infectious processes other than MAC prior to study entry.
Required:
* Patients must be on a stable antiretroviral regimen (same drug or combination drugs; dose modifications allowed) for at least 4 weeks prior to study entry.
NOTE:
* Patients will be requested NOT to modify or add new drugs to their stable ARV regimen for the duration of this study. Patients who absolutely require ARV changes at any time prior to week 8 will continue on study, however, their data will be analyzed separately.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Previous enrollment and permanent study drug discontinuation in ACTG 223.
Note:
* Co-enrollment in ACTG 223 and ACTG 853 is acceptable, however enrollment in both studies must be simultaneous.
* This protocol does not meet federal requirements governing prisoner participation in clinical trials and should not be considered by local IRBs for the recruitment of prisoners.
Concurrent Medication:
Excluded:
* Cytokine inhibitors.
* Corticosteroids.
* Thalidomide.
* Pentoxifylline or any other immunomodulator.
* Any interleukin.
* Colony stimulating factors (G-CSF or GM-CSF)
Patients with the following prior conditions will be excluded:
* Subjects who have had an opportunistic infection (other than MAC) within 14 days immediately preceding study entry.
Prior Medication:
Excluded within the 14 days immediately preceding study entry:
* Cytokine inhibitors.
* Corticosteroids.
* Thalidomide.
* Pentoxifylline or any other immunomodulator.
* Any interleukin.
* Colony stimulating factors (G-CSF or GM-CSF)
Prior Treatment:
Excluded:
* Patients who have received a blood transfusion within the 14 days immediately preceding study entry.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00000860
Study Brief:
Protocol Section:
NCT00000860