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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT00000893
Eligibility Criteria:
Inclusion Criteria
Children may be eligible for this study if they:
* Are HIV-positive.
* Are between 3 months and 16 years old (consent of parent or legal guardian required). (These age requirements reflect a change.)
* Have a plasma viral load of at least 400 copies/ml at screening.
* Agree to practice abstinence or use effective methods of birth control during the study.
* Are able to take oral medication and comply with study requirements.
* Are taking at least 1 nucleoside reverse transcriptase inhibitor (NRTI), such as zidovudine (ZDV) or stavudine (d4T). Patients can begin taking NRTIs at the beginning of the study.
Exclusion Criteria
Children will not be eligible for this study if they:
* Have had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to study entry.
* Are allergic to EFZ or NFV.
* Have any disease, including hepatitis, cancer, or an active opportunistic (HIV-associated) infection.
* Are pregnant or breast-feeding.
* Are taking any other experimental drugs or certain medications.
* Have ever taken protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
16 Years
Study:
NCT00000893
Study Brief:
Protocol Section:
NCT00000893