At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PENTA15: Plasma Pharmacokinetic Study of Once Versus Twice Daily Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV-1 Infection Aged 3 Months to <36 Months
In Brief
A Phase 1 clinical trial evaluating Intervention 1: PK assessment while on Twice Daily Abacavir and Intervention 2: PK assessment while on Once Daily Abacavir for HIV Infection. Completed, enrolled 23 participants across 10 sites in 5 countries.
Detailed Summary
To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir in HIV-1-infected infants and children aged 3 months to 36 months The secondary objectives of PENTA15 were: To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir To compare age-related differences in the PK parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to \<12 months, ≥12 to \<24 months and ≥24 to \<36 months) To describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine
Study Details
Timeline
Interventions
Week 0
Week 4