About the project

EMPIRICAL is an acronym of “Empirical treatment against cytomegalovirus and tuberculosis in severe pneumonia in HIV-infected infants: a randomized controlled clinical trial”. It is a research project funded by European and Developing Countries Clinical Trial Partnership (EDCTP) that aims to develop a clinical trial to evaluate whether empirical treatment against cytomegalovirus and tuberculosis improves survival of HIV-infected infants with severe pneumonia.

A randomized factorial clinical trial will be conducted in six sub-Saharan African countries (Ivory Coast, Mozambique, Uganda, Zambia, Zimbabwe and Malawi) to evaluate the safety and efficacy of empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants aged 1 month to 12 months admitted to hospital with severe pneumonia. Study end-points include 15-day and 12-month survival.

HIV-infected infants will receive standard of care pneumonia treatment, including antibiotics, cotrimoxazole and prednisolone. Participants will be randomized simultaneously to receive or not receive each of the two interventions (treatment against cytomegalovirus or treatment against tuberculosis) being allocated in one of the following 4 arms:

1. Standard of care
2. Valganciclovir plus standard of care
3. Tuberculosis treatment plus standard of care
4. Valganciclovir plus tuberculosis treatment plus standard of care

The primary aim of EMPIRICAL is to test if empirical treatments against cytomegalovirus with valganciclovir and against tuberculosis decrease short and medium-term mortality in HIV-infected infants with chest indrawing or severe pneumonia.

Secondary aims are:

• To evaluate the safety of empirical valganciclovir and treatment against tuberculosis in HIV-infected infants.
• To assess the drug interactions of antiretrovirals and tuberculosis treatment in infants.
• To improve the knowledge of low respiratory infections diseases in HIV-infected infants with severe pneumonia.
• To build and strengthen the capacity of clinical trials sites in Africa.
• To strengthen the European-African research networks to approach poverty-related diseases.

The EMPIRICAL project will mobilize 14 European and Sub-Saharan countries, research teams and will be sponsored by the European and Developing Countries Clinical Trials Partnership Association (EDCTP). (The grant agreement number is RIA2017MC – 2013.)

February 1, 2019 was the starting date of the project. It will be carried out over a period of 60 months.