Pharmacokinetics of Pediatric Aluvia® (Lopinavir /Ritonavir 100/25 mg) and Generic Lopinavir/Ritonavir Tablet Formulation (200/50 mg) in Clinically and Virologically Stable HIV-1 Infected Thai Adults

NCT01159275 Phase 1/Phase 2 COMPLETED

The purpose of this study is to study the pharmacokinetics profiles of generic lopinavir/ritonavir and Pediatric Aluvia® at reduced dose by assessing safety, tolerability and efficacy.

Details

Lead sponsor	The HIV Netherlands Australia Thailand Research Collaboration
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	20
Start date	2009-07
Completion	2010-03

Conditions

• HIV-1 Infections

Interventions

• Generic LPV/r and Aluvia (pharmacokinetics)
• Aluvia and Generic LPV/r (pharmacokinetics)

Primary outcomes

• AUC, Cmin, Cmax of LPV/r between Aluvia and generic — week 2
  AUC, Cmin, Cmax of LPV/r between Aluvia and generic

Countries

Thailand