Evaluation of use of Dolutegravir in children aged 6 to 12 years: a multicenter study in Brazil
Recruiting
- Conditions
- Human immunodeficiency virus (HIV) disease resulting in infectious and parasitic diseases
- Registration Number
- RBR-87x8h69
- Lead Sponsor
- Faculdade de Medicina, Universidade Federal de Minas Gerais/UFMG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Children; both genders; from 6 to 12 years of age; weighing 20 kilos or more; infected by HIV (Human Immunodeficiency Virus); using a stable antiretroviral regimen; with a prescription for Dolutegravir.
Exclusion Criteria
Any previous exposure to DTG (Dolutegravir) including participation in a clinical trial or a compassionate use/medical need program; history, presence of known allergy, or contraindications to DTG (Dolutegraivr) use; known previous genotypic resistance to Integrase Inhibitor.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the proportion of participants experiencing virologic failure after switching to DTG-based ART in children from 6 to 12 years.
- Secondary Outcome Measures
Name Time Method Describe demographics and clinical characteristics among overall HIV children. Estimate the absolute and percentual change in CD4+ count after switching to DTG-based ART at each follow up visit. Estimate the proportion of participants experiencing Dolutegravir associated adverse events, DTG discontinuation and laboratory abnormalities in children taking DTG-based ART at each follow up visit. <br>•Estimate and compare trends in weight and body mass index (BMI) after initiation of DTG-based ART.<br>