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Clinical Trial Summary

The study will be carried out to provide supportive clinical data on the feasibility, efficacy, safety, and PK of LPV based therapies in routine treatment setting and will be based on the existing LPV/r pellets which already represent a clear advantage in comparison with the liquid formulation.


Clinical Trial Description

The primary objective is to evaluate the effectiveness of LPV/r pellets in addition to AZT/3TC (or ABC/3TC) paediatric fixed dose combination (FDCs) tablet under routine treatment conditions in HIV infected infants and young children who cannot swallow tablets.

As secondary objectives:

- Document the safety of LPV/r pellets and AZT/3TC or ABC/3TC

- Assess the population pharmacokinetics of LPV/r and NRTIs when administered as LPV/r pellets plus AZT/3TC or ABC/3TC

- Measure adherence to the new formulation

- Evaluate children acceptability of the LPV/r pellets and associated dual NRTIs as well as ease of use by the care giver. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02346487
Study type Interventional
Source Drugs for Neglected Diseases
Contact
Status Completed
Phase Phase 3
Start date September 2015
Completion date May 14, 2019

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