HIV Clinical Trial
Official title:
Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children
A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability
study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose
Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg
tablets) in HIV infected Children.
The study is intended to support the adoption of the 4-in-1 by healthcare providers and will
provide data that may support its registration in certain countries. The study will be
carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to
swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety,
tolerability and acceptability of the 4-in-1.
The primary objective is to estimate the population average exposure to LPV, ABC and 3TC
provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.
The secondary objectives:
- To determine the proportion of children overall, and within each weight band, with a
lopinavir C12 <1.0 mg/L while receiving the 4-in-1 formulation
- To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a
reference treatment regimen.
- To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a
reference treatment regimen.
- To assess post exposure CD4 and viral load
- To assess the factors that contribute to acceptability of the new 4-in-1 formulation.
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