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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

The numbers of cases of sleeping sickness (human African trypanosomiasis, HAT) have fallen markedly in the past decade, raising hopes that the disease can be eliminated entirely. Efficient methods of detecting the cause of sleeping sickness, the parasite Trypanosoma brucei gambiense, will be pivotal to eradication, enabling monitoring of at-risk populations for infections, and would also provide valuable tools for evaluating new treatments in clinical trials.

The DiTECT-HAT study will evaluate three different approaches for detecting trypanosome infections. The first is based on new rapid diagnostic tests, which could be used to screen for infections in people visiting clinics, who could then immediately be started on treatment. This approach is being evaluated in three countries.

The second approach is designed for large-scale monitoring of populations at risk to assess the effectiveness of elimination campaigns. Blood samples will be collected on filter paper by health workers travelling door to door, and then sent to central laboratories for analysis. This method is being tested in three countries where sleeping sickness is now rare.

In the third strand of the project, the DiTECT-HAT team will see whether sophisticated molecular tests can provide a rapid indication that drug treatments are killing parasites, which could help to speed up the development of new drugs. This work will take advantage of an ongoing clinical trial in the Democratic Republic of the Congo.

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 different scenarios require slightly different methods for detecting trypanosome infections. By evaluating different tools and pathways of analysis, the DiTECT-HAT could identify how the range of diagnostic tools could be deployed most effectively to treat infection in routine care, to support eradication campaigns, and to facilitate the development of new drugs.

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