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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT00001118
Eligibility Criteria:
Inclusion Criteria
Children may be eligible for this study if they:
* Are 3 to 12 years old (consent of parent or guardian required).
* Are HIV-positive.
* Are receiving combination anti-HIV therapy. He/she must have been taking this combination for at least 16 weeks, and it must include either 2 NRTIs alone or 2 NRTIs plus either an NNRTI or a PI. (This study has been changed. This no longer has to be a child's first anti-HIV drug combination.)
* Have a viral load greater than 10,000 copies/ml while taking this anti-HIV drug combination.
* Have never received treatment with a PI or an NNRTI. (One or two doses are allowed.)
* Have never taken at least 1 NRTI.
Exclusion Criteria
Children will not be eligible for this study if they:
* Are receiving treatment for an opportunistic (AIDS-related) or serious bacterial infection at the time of study entry.
* Are receiving chemotherapy for cancer.
* Have certain serious diseases (other than HIV) or conditions.
* Have received or are currently receiving certain medications.
* Are pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT00001118
Study Brief:
Protocol Section:
NCT00001118