ARROW: Anti-retroviral research for Watoto
Investigating new treatment strategies for children with HIV in Africa: How many blood tests are needed to treat children with HIV and does initially giving more anti-HIV drugs improve a child’s long term prospects?
What was this study about?
In 2011, around 3.3 million children were living with HIV/AIDS, and around 330,000 children were newly infected with HIV. The vast majority of these children live in sub-Saharan Africa. At the moment there is no cure for HIV. However, there are anti-HIV medicines that can help to control it. We wanted to find out how best to use these medicines in children in Africa so that treating them is safe, effective and as easy as possible.
Currently, doctors use regular blood tests, usually every 12 weeks, to see how well the medicines are working. However, these blood tests are both expensive and not widely available. ARROW aimed to find out whether:
1. Anti-HIV drugs can be given safely and effectively without doing so many blood tests
2. Starting children on four anti-HIV drugs for a short period of time before continuing with 3 drugs is better over the long term, compared with being on 3 drugs from the start
3. Children who are stable on HIV treatment need to continue taking the drug cotrimoxazole to reduce illness
4. A once-daily dose of the drugs abacavir and lamivudine is as good as taking it twice a day
ARROW also investigated a number of other aspects relating to HIV treatment, including adherence to treatment (i.e. whether the children are taking the medicines as prescribed) and the appropriate doses of these anti-HIV medicines when given as scored tablets, which may also be given only once daily.
Who took part?
A total of 1,206 children who needed to start taking anti-HIV treatment.
When was it carried out?
Recruitment to the trial started in March 2007 and was completed in November 2008. Follow up finished in March 2012.
Where did it take place?
University of Zimbabwe, Harare, Zimbabwe; Joint Clinical Research Centre, Kampala, Uganda; The Paediatric Infectious Diseases Clinic (PIDC), Mulago Hospital, Kampala, Uganda; MRC/Uganda Virus Research Institute Programme on AIDS, Entebbe, Uganda
Who funded the study?
The work was funded jointly by the UK’s Department for International Development (DFID) and the Medical Research Council (MRC). Some drugs were provided by GlaxoSmithKline limited.
What difference did this study make?
Children in the ARROW trial did very well on treatment. Routine laboratory tests to monitor for side-effects provided no benefit. Routine laboratory tests to measure the strength of children’s immune system only provided a very small and late benefit, mainly in older children. This means that HIV treatment can be delivered safely to children with good quality clinical care, and lack of access to laboratory tests should not be a barrier to putting children on treatment.
Children who continued to take the drug cotrimoxazole were less likely to have to be admitted to hospital or die than children who stopped taking it.
Children who received 4 drugs at the start of their treatment had a better early response than those who took 3 drugs. After the fourth drug was stopped, these benefits did not carry on.
Evidence from the ARROW trial has helped to inform the World Health Organisation’s 2013 guidelines on antiretroviral therapy, and may inform future national guidelines for treating children with HIV. They have also helped the World Health Organisation to update their guidance on cotrimoxazole prophylaxis. The results provide encouragement to healthcare workers to get more children onto HIV treatment.
|Type of study:||Randomised trial|
|Also included in this study:||Health Economics|
Quality of life outcomes
|Chief investigator:||Dr Munderi, Profs Mugyenyi, Kekitiinwa, Nathoo, Gibb|
|Intervention and control groups:||Antiretroviral therapy|
|Method of randomisation:||Stratification with blocking|
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