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Antiretroviral research for Watoto
ISRCTN ISRCTN24791884
DOI 10.1186/ISRCTN24791884
ClinicalTrials.gov identifier
EudraCT number
Public title Antiretroviral research for Watoto
Scientific title
Acronym ARROW
Serial number at source G0300400
Study hypothesis The key objectives are to determine:
1. Will clinically driven monitoring (CDM) have a similar outcome in terms of disease progression or death as routine laboratory and clinical monitoring (LCM) for toxicity (haematology/biochemistry) and efficacy (CD4)?
2. Will induction with four drugs (2 antiretroviral therapy [ART] classes) followed by maintenance with three drugs after 36 weeks be more effective than a continuous non-nucleoside reverse transcriptase inhibitors (NNRTI)-based triple drug regimen in terms of CD4 and clinical outcome?

In addition there will be a sub-study to evaluate a visual analogue scale for assessing 28-day adherence to ART, by comparing with 3-day recall, pill and bottle counts (including unannounced checks at home). This will be performed on a subset of children enrolled in the trial.
Lay summary http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=6
Ethics approval Added as of 27/07/2007:
1. University College London (UCL) (UK), on 25/05/2006 (ref: 0701/001)
2. Ugandan National Council for Science & Technology (UNCST) (Uganda) on 16/02/2006
3. JCRC IRB/REC & Uganda Virus Institute Science and Ethics Committee (Uganda) on 14/07/2006
4. Baylor College of Medicine (Uganda), approved on 12 October 2006 (Uganda) on 12/10/2006 (ref: H-19616)
5. Medical Research Council of Zimbabwe (MRCZ) (Zimbabwe) on 05/04/2007 (ref: MRC/A/1321)
6. Medicines Control Authority of Zimbabwe (MCAZ) (Zimbabwe) on 04/05/2007 (ref: B/279/5/52/2007)
Study design Randomised trial of monitoring practice and induction maintenance drug regimens
Countries of recruitment Uganda, Zimbabwe
Disease/condition/study domain Human immunodeficiency virus
Participants - inclusion criteria 1. Children should have an adult carer in the household who is either:
a. Participating in the DART trial (ISRCTN13968779) or
b. Being treated with ART or
c. HIV positive but not yet needing treatment but with access to a treatment program when ART is required or
d. HIV negative
2. Parents or guardians, and children where appropriate according to age and knowledge of HIV status, must be willing and able to give informed consent for randomisation to clinically driven monitoring (CDM) or laboratory and clinical monitoring (LCM) and to first-line ART strategy
3. Participants must have a confirmed and documented diagnosis of HIV-1 infection
4. At entry participants should be aged:
a. 6 Months to 17 years among children and adolescents from DART households
b. 6 Months to 12 years among children in non-DART households
5. Participants must be ART naive (except for exposure to perinatal ART for the prevention of mother-to-child HIV transmission)
6. Participants must meet the criteria for requiring ART according to World Health Organization (WHO) stage and CD4 count or CD4 cell percent
Participants - exclusion criteria 1. Cannot, or unlikely to attend regularly
2. Likelihood of poor adherence
3. Presence of acute infection
4. In receipt of medication contraindicated by ART or on chemotherapy for malignancy
5. Laboratory abnormalities, which are a contraindication for the patient to start ART
6. Pregnant or breast-feeding
Anticipated start date 02/10/2006
Anticipated end date 14/03/2012
Status of trial Completed
Patient information material Patient information can be found at: http://www.arrowtrial.org/faqs.asp
Target number of participants 1,200
Interventions First randomisation is to CDM or LCM (1200 children). Second randomisation is to either continuous or induction-maintenance ART strategies for first-line therapy. Children will be randomised immediately after their first randomisation to CDM or LCM.
Primary outcome measure(s) The primary endpoints are:
1. Monitoring practice (n = 1200):
a. Efficacy: progression to a new WHO stage 4 or death
b. Safety: any adverse events of grade 3 or 4, which are not HIV-related only

2. ART strategies for first-line therapy (n=1200):
a. Efficacy: progression to a new WHO stage 4 or death and change in CD4 percentage at 72 and 144 weeks
b. Safety: any adverse events of grade 3 or 4, which are not HIV-related only
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 1. Medical Research Council (MRC) (UK) (ref: G0300400)
2. The Department for International Development (DFID) (UK)
Trial website http://www.arrowtrial.org
Publications 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23473847
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24382064
Contact name Prof  Diana  Gibb
  Address Clinical Trials Unit, Medical Research Council
222 Euston Road
  City/town London
  Zip/Postcode NW1 2DA
  Country United Kingdom
  Tel +44 (0)20 7670 4709
  Email d.gibb@ctu.mrc.ac.uk
Sponsor Medical Research Council (UK)
  Address Medical Research Council Centre
Stephenson House
158-160 North Gower Street
  City/town London
  Zip/Postcode NW1 2ND
  Country United Kingdom
  Tel +44 (0)20 7670 4625
  Email ian.viney@centre-london.mrc.ac.uk
Date applied 19/04/2006
Last edited 17/01/2014
Date ISRCTN assigned 09/06/2006
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