Human immunodeficiency virus (HIV) disease resulting in infectious and parasitic diseases
Conditions
Interventions
The study population will be composed of 250 children infected with the human immunodeficiency virus, aged between 6 and 12 years, on a stable antiretroviral regimen and with indication of switching t
E02.319.310.075
Sponsors
Faculdade de Medicina, Universidade Federal de Minas Gerais/UFMG
Faculdade de Medicina, Universidade Federal de Minas Gerais/UFMG
Eligibility
Age
6 Years to 12 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the proportion of participants experiencing virologic failure after switching to DTG-based ART in children from 6 to 12 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. • Estimate and compare trends in weight and body mass index (BMI) after initiation of DTG-based ART. | — |
Countries
Brazil
Contacts
Public ContactJorge Pinto
Faculdade de Medicina, Universidade Federal de Minas Gerais/UFMG
Outcome results
None listed