NCT05784584

Early Anti-Retroviral Treatment in HIV- Infected Children

A Prospective, Observational, Cohort, Multicenter Study of Early Anti-Retroviral Treatment in HIV- Infected Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: PENTA Foundation · Network
• Sex: All
• Age: 180 Days
• Healthy volunteers: Not accepted

Summary

EARTH study is conducted as part of the EPIICAL project. It is a prospective cohort study which aims to monitor clinical, virological and immunological features of HIV-positive, early treated children (≤90 days after diagnosis), in order to identify participants with excellent viral and immunological control, and also other without excellent control, in order to stratify potential participants in proof-of-concept trials directed to HIV cure.

Detailed description

The duration of the study is 4 years from the start of enrollment with at least 4 years of follow-up for each participant. The study is conducted in South Africa, Mali, and Mozambique with an expected enrollment target of 200 participants (as a minimum). In this study, newly diagnosed HIV-infected children will start ART as early as possible, following local standards of care, and will be followed up to 4 years of age. Clinical and blood data for viral load, immunology, and serology will be collected at the 11 visits. HIV reservoir size and HIV-specific immune responses will be analyzed at visit 1 and at 1, 2, 3, and 4 years after enrollment. We will identify children with HIV infection eligible to participate in proof-of-concept treatment/remission studies. A predictive model developed from European participant data will help identify children with low reservoir. These predictions will then be compared with available data from participants already enrolled with an excellent control to refine the model.

Conditions

• HIV Infections

Interventions

Type	Name	Description
PROCEDURE	Blood samples collection	The study population will take blood samples for virological and immunological measurements.

Timeline

• Start date: 2018-05-01
• Primary completion: 2024-02-28
• Completion: 2024-03-28
• First posted: 2023-03-27
• Last updated: 2024-12-30

Locations

6 sites across 3 countries: Mali, Mozambique, South Africa