NCT01973439

PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 3 Months – 36 Months
• Healthy volunteers: Not accepted

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

Conditions

• HIV Infection

Interventions

Type	Name	Description
OTHER	Intervention 1: PK assessment while on Twice Daily Abacavir	Week 0
OTHER	Intervention 2: PK assessment while on Once Daily Abacavir	Week 4

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-06-01
• Completion: 2009-06-01
• First posted: 2013-10-31
• Last updated: 2014-03-20
• Results posted: 2014-03-20

Locations

10 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom