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

In the News

Study establishes link between gender, extramarital affairs and HIV

Dar es Salaam. A new Ifakara Health Institute study has found “a significant association between lifetime (proxy) extramarital affairs and HIV infection among women only,” with the risk being significantly …

IHI names winners of research, innovation fund

[Right-Left] Getrud, Beatrice, Theckla, and Tutu.Ifakara Health Institute (IHI) has named recipients of the 2017/18 Director’s Research and Innovation Fund. This is an internal funding mechanism aimed to support specific …

Recent Projects

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 …

Demonstrating complete disruption of residual malaria transmission by eliminating Anopheles funestus mosquitoes from rural Tanzanian villages

In rural south-eastern Tanzania, where malaria prevalence has reduced by >60% since 2000, low-to-moderate transmission still persists despite very high coverage with long-lasting insecticidal bednets. Like in most residual transmission …

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