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test the safety and efficacy of this new formulation in young children

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

Dr Liyoyo is active as a researcher and clinician at the Kibong’oto Infectious Diseases Hospital in Tanzania and the challenge he has set for himself is to become a specialist in clinical research on infectious diseases. His objective and the fellowship reflect the wider challenge in sub-Saharan Africa, the relatively low rate of trained researchers that are able to compete for funding, inform policy-making and address national infectious disease challenges.

Through the fellowship Dr Liyoyo seeks to boost hands-on skills and experience in the following areas: pharmacology, pharmacokinetics, and pharmacodynamics of old and new antibiotics for TB, TB/HIV and MDR-TB including those in early clinical phases and their interaction with other drugs. Secondly, he expanded his skills in designing a clinical research protocol, including developing the hypothesis, perform a literature review and submitting a proposal to regulatory and ethical review committees. To that end he also studies regulations of the Food and Drug Administration as well as Institutional Review Board policies.

After his placement at Novartis (Switzerland), he will retrun to the Kibong’oto Infectious Diseases Hospital and continue his career as a clinical researcher at the hospital. Besides further pursuing his own specialisation, he will teach, train, support and mentor junior scientists. He aims to mobilise research funding through teamwork and networking, nationally, regionally and internationally. Interestingly, he plans to disseminate his experience during the fellowship with a view to promoting fellowships as an instrument of capacity development. His approach comprises a peer-reviewed manuscript for publication; a short manuscript on capacity building and lessons learnt in an appropriate open access journal; a policy brief with recommendations specific to the Ministry of Health and Ministry of Science & Technology in Tanzania promoting a fellowship programme in the country; a press release for a general audience; and presentations at scientific conferences.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

Dr Liyoyo expects his fellowship will have impact at various levels: individually, at his home institution, the Kibong’oto Infectious Diseases Hospital, in a wider academic circle of students and colleagues, and perhaps at the level of national policymaking, through both the research supporting disease control and advocacy for a national fellowship programme.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact