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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT00762320
Eligibility Criteria:
Inclusion Criteria:
* HIV+ children aged 3-18.
* Baseline treatment includes liquid Kaletra
* currently on a stable (on same regimen \> 3 months, Viral Load\< 5,000), Highly Active Antiretroviral Therapy (HAART) regimen
* able to take pills or willing to undergo pill training prior to enrollment
* weight must be greater than or equal to 15kg
Exclusion Criteria:
* Unable to swallow pills
* Concomitant treatment with Rifampin or St. John's Wort which have been shown to decrease plasma concentrations of lopinavir.
* Concurrent use of drugs primarily metabolized by CYP3A, which metabolizes ritonavir: Astemizole, Cisapride, Dihydroergotamine, Ergonovine, Ergotamine, Flecainide, Lovastatin, Methylergonovine, Midazolam, Pimozide, Propafenone, Simvastatin, terfenadine, Triazolam
* Baseline treatment does NOT include Kaletra
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT00762320
Study Brief:
Protocol Section:
NCT00762320