The TREATS study will reveal whether combined HIV and TB interventions targeting entire populations have an impact on the prevalence of TB.

Tackling TB and HIV together

TB is responsible for around 40% of the deaths of people living with HIV. Hence there is great interest in interventions that address both infections.

Control of HIV is increasingly moving towards ‘test and treat’ strategies, screening as many people as possible and starting antiretroviral therapy in all those found to be infected with HIV.  Potentially, approaches to TB detection and prevention could be integrated into population-based initiatives to identify HIV infections.

The challenge

The HPTN 071 (PopART) trial, the largest trial ever of combined HIV and TB prevention, involving around one million people, found that targeting entire populations cut the number of new HIV infections by 30%. The TREATS study is using the PopART trial infrastructure to determine whether population screening for active TB, piggybacking universal HIV testing and treatment, leads to a reduction in the community burden of TB.

The trial is taking place in 21 communities in South Africa and Zambia. A trial on the scale of PopART is unlikely ever to be repeated, so it provides a unique opportunity to collect data on population-based approaches for detecting TB.

TREATS will also use a range of methods for detecting TB infections and cases of active TB (most cases of TB are inactive, or latent; people with latent TB infections cannot spread the disease). These studies will provide a wealth of data on the best ways of measuring the number of new cases of TB each year and the prevalence of TB infection and disease.

The project

The TREATS trial is a unique opportunity to gather information from large numbers of people on the impact of a combined HIV and TB control intervention on the TB disease burden. As countries move to more population-based HIV control strategies, its findings will help policymakers decide whether to combine large-scale TB and HIV screening.

Impact


crucial in

widening African

children’s access

to antiretrovirals

Bringing antiretroviral drugs to children

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

EDCTP portfolio: HIV & HIV-associated infections

The challenge

TB is responsible for around 40% of the deaths of people living with HIV. Hence there is great interest in interventions that address both infections.

Control of HIV is increasingly moving towards ‘test and treat’ strategies, screening as many people as possible and starting antiretroviral therapy in all those found to be infected with HIV.  Potentially, approaches to TB detection and prevention could be integrated into population-based initiatives to identify HIV infections.

The HPTN 071 (PopART) trial, the largest trial ever of combined HIV and TB prevention, involving around one million people, found that targeting entire populations cut the number of new HIV infections by 30%. The TREATS study is using the PopART trial infrastructure to determine whether population screening for active TB, piggybacking universal HIV testing and treatment, leads to a reduction in the community burden of TB.

The trial is taking place in 21 communities in South Africa and Zambia. A trial on the scale of PopART is unlikely ever to be repeated, so it provides a unique opportunity to collect data on population-based approaches for detecting TB.

TREATS will also use a range of methods for detecting TB infections and cases of active TB (most cases of TB are inactive, or latent; people with latent TB infections cannot spread the disease). These studies will provide a wealth of data on the best ways of measuring the number of new cases of TB each year and the prevalence of TB infection and disease.

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.

The TREATS trial is a unique opportunity to gather information from large numbers of people on the impact of a combined HIV and TB control intervention on the TB disease burden. As countries move to more population-based HIV control strategies, its findings will help policymakers decide whether to combine large-scale TB and HIV screening.

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

L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.

Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.

WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.

WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing

HIV infection: Recommendations for a public health approach
(second edition). 2016

Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3

Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)

Target population(s): Children with HIV

Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)

Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)

Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)

EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)

Total project funding: €1.2M (CHAPAS-1); €5.0M

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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