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 is this study about?
In 2006, around 2.3 million children were living with HIV/AIDS, and around 500,000 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 want 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 aims 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.
ARROW will also investigate a number of other aspects relating to HIV treatment, including adherence to treatment (i.e. whether the children are taking the pills 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 is included?
A total of 1,200 children who need to start taking anti-HIV treatment.
When is it taking place?
Started in March 2007 and was completed in November 2008. Follow up will continue to April 2012.
Where is it taking 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 is funding the study?
The work is being funded jointly by the UK’s Department for International Development (DfID) and the Medical Research Council (MRC). Some drugs will be provided by GlaxoSmithKline limited.
|Type of study:||Randomised trial|
|MAMS||This is a multi arm multi stage study|
|Status:||Closed to recruitment; in follow-up|
|Study start date:||Mar-07|
|Registrations achieved:||327, as of October 2007|
|Randomisations achieved:||327, as of October 2007|
|Also included in this study:||Health Economics|
Quality of life outcomes
|Chief investigator:||Dr Munderi, Profs Mugyenyi, Kekitiinwa, Nathoo, Gibb|
|Inclusion criteria:||Children should have an adult carer in the household who, if HIV positive, is receiving Anti-HIV therapy if needed; parents or guardians, and children where appropriate must be willing and able to give informed consent; children must have a documented diagnosis of HIV infection; age 6 months to 12 years (up to 17 years for children from DART households); previously untreated with anti-HIV drugs (other than for the prevention of mother-to-child transmission); children must fulfil World Health Organisation criteria for starting treatment.|
|Exclusion criteria:||1. Cannot, or unlikely to attend regularly; likelihood of poor adherence; presence of acute infection; receiving medication that cannot be taken in combination with anti-HIV drugs; laboratory abnormalities which prevent anti-HIV drugs being taken; girls: pregnancy or breast-feeding.|
|Intervention and control groups:||Antiretroviral therapy|
|Method of randomisation:||Stratification with blocking|
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