NCT01982396

Pharmacokinetic (PK) Study of Twice Daily vs Once Daily Lamivudine (3TC) and Abacavir (ABC) as Part of Combination Antiretroviral Therapy (ART) in HIV Infected Children

Pharmacokinetic Study of Twice Daily vs Once Daily Lamivudine and Abacavir as Part of Combination Antiretroviral Therapy in Children With HIV Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 2 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

Cross-over 28 week study of the plasma pharmacokinetic profiles of twice daily 3TC (4mg/kg/dose BD) with once daily 3TC (8mg/kg/dose OD) and twice daily ABC (8mg/kg/dose BD) with daily ABC (16mg/kg/dose OD) where one or both drugs are being taken as part of combination antiretroviral therapy.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	ABC Twice Daily
DRUG	ABC Once Daily
DRUG	3TC Once Daily
DRUG	3TC Twice Daily

Timeline

• Start date: 2003-01-01
• Primary completion: 2004-02-01
• Completion: 2004-03-01
• First posted: 2013-11-13
• Last updated: 2013-11-13

Locations

2 sites across 1 country: United Kingdom