Evaluation of Lopinavir-based anti-retroviral therapy for...

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Swiss envoys visit Bagamoyo sites to boost ties

(Bagamoyo) Swiss Ambassador to Tanzania Florence Tinguely Mattli and Head of Sub-Saharan Africa and Francophone Division in the Swiss Department of Foreign Affairs Ambassador Anne Lugon-Moulin visited Ifakara Health Institute’s …

IHI, partners kick off China-TZ malaria project

(Dar es Salaam) Ifakara Health Institute (IHI) today joins public health partners in hosting the kick off meeting for the China-Tanzania malaria project to be implemented for one year from …

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Sustainable, Healthy, Learning Cities and Neighbourhoods

The Sustainable, Healthy, Learning Cities and Neighbourhoods is an exciting project in which IHI works with a consortium of partners from Asia and Africa to 1) develop capacity for improved …

Development of a new tool for malaria mosquito surveillance to improve vector control

Malaria transmission is influenced not only by vector abundance, but as well by demographic traits such as vector species and age structure, as these influence the intensity by which the …

Prospective study of Lopinavir based ART for HIV infected children globally; phase IIIb clinical trial in Ifakara.

The WHO antiretroviral treatment guidelines reemphasize the need to treat all HIV-infected children below 5 years of age and for children less than 3 years of age to initiate therapy with a ritonavir-boosted lopinavir (LPV/r) based regimen. However, by making this recommendation “when feasible,” WHO recognizes the programmatic complexity of providing infants and young children with the currently available LPV/r liquid (80/20mg) or baby tablets (100/25mg) formulations. A new formulation of LPV/r has been developed by Cipla pharmaceuticals, India, consisting of LPV/r pellets (40/10mg). This new formulation does not need refrigeration, is alcohol-free and can be opened and administered orally to infants and young children. A pharmacokinetics study of this new formulation showed that the exposure to LPV/r from pellets is comparable with syrup and its acceptability is better. This study (also dubbed the LIVING study) aims to provide supportive clinical data on feasibility, efficacy, safety, and pharmacokinetics of LPV/r-based therapies for children in routine treatment settings, and will be based on the existing LPV/r pellets, which already represent a clear advantage in comparison with the liquid formulation.

The specific aims of the study are: 1) Evaluate the effectiveness of LPV/r pellets in addition to AZT/3TC (or ABC/3TC) paediatric fixed dose combination tablet under routine treatment conditions in HIV-infected infants and children, 2) Document the safety of LPV/r pellets and AZT/3TC or ABC/3TC, 3) Assess the population pharmacokinetics of LPV/r and NRTIs when administered as LPV/r pellets  plus AZT/3TC or ABC/3TC, 4) Measure  adherence to the new formulation, and 5) Evaluate children acceptability of the LPV/r pellets and associated dual NRTIs as well as ease of use by the care giver.

Lead scientists:

Maja Weisser

Ezekiel Luoga

 

Partners

Swiss Tropical and Public Health Insitute
Management and Development for Health (MDH)
Cipla

Funders

Drugs for Neglected Diseases initiative (DNDi)

Projects Location

A PIXELBASE DESIGN
© Ifakara Health Institute (IHI), 2016