Antiretroviral research for Watoto

Not Applicable

• Conditions: Human immunodeficiency virus; Infections and Infestations

• Registration Number: ISRCTN24791884
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23473847 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24382064 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27064996 results 2017 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/29136032 observational analyses Results article in https://pubmed.ncbi.nlm.nih.gov/34270487/ Sub study results (added 19/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-09
• Study Completion: 2012-03-14
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Children should have an adult carer in the household who is either:
1.1. Participating in the DART trial (ISRCTN13968779) or
1.2. Being treated with ART or
1.3. HIV positive but not yet needing treatment but with access to a treatment program when ART is required or
1.4. 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:
4.1. 6 Months to 17 years among children and adolescents from DART households
4.2. 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

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 breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Monitoring practice (n = 1200):<br> 1.1. Efficacy: progression to a new WHO stage 4 or death<br> 1.2. Safety: any adverse events of grade 3 or 4, which are not HIV-related only<br><br> 2. ART strategies for first-line therapy (n=1200):<br> 2.1. Efficacy: progression to a new WHO stage 4 or death and change in CD4 percentage at 72 and 144 weeks<br> 2.2. Safety: any adverse events of grade 3 or 4, which are not HIV-related only<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures