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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT00978068
Eligibility Criteria:
Inclusion criteria:
1. Age 2 months to \< 11 years
2. Confirmed HIV diagnosis. i. Children \> 18 months: Documentation of HIV status must come from two assays. Assays include DNA PCR, HIV RNA, Western blot, or rapid HIV antibody test ii. Children \< 18 months: Documentation will be DNA PCR confirmation only along with documentation of testing from the referral entity
3. ART-naïve patients eligible for ART initiation per WHO/Uganda guidelines (see Table 1) or Patients receiving first line ART regimen with NNRTI +2 NRTI with at least one HIV RNA \<400 copies/ml within the past 6 months
4. Agreement to come to the study clinic for any febrile episode or other illness
5. Agreement to avoid medications administered outside study protocol
6. Provision of informed consent by parent/guardian and agreement to have child's care at the clinical site
7. Lives within 50 km of study site
Exclusion criteria:
1. ART-naïve children: children or their mothers that have received any dose of Nevirapine in the past 24 months
2. Active medical problem requiring in-patient evaluation at the time of screening or enrollment
3. History of cardiac conduction disorder or known significant cardiac structural defect
4. Children receiving any disallowed medications (see section 4.3)
5. Moderate, Severe or Life-threatening (Grade 2, 3, or 4) AST or ALT found within 4 weeks prior to enrollment:
* AST: \>113U/L (\>2.5xULN)
* ALT: \>113U/L (\>2.5xULN)
6. Life-threatening (Grade 4) screening laboratory value found within 4 weeks prior to enrollment for the following:
* Absolute neutrophil count: \<500 mm3
* Hemoglobin: \<6.5 g/dL
* Creatinine: \>3.5xULN
* Platelets: \<25,000/mm3
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
10 Years
Study:
NCT00978068
Study Brief:
Protocol Section:
NCT00978068