Early Anti-Retroviral Treatment in HIV- Infected Children

PENTA Foundation

Status: Completed

Conditions: HIV Infections

Treatments: Procedure: Blood samples collection

Study type: Observational

Funder types: NETWORK

Identifiers

NCT05784584

EARTH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: Under 180 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Perinatally infected infants who start ART at ≤90 days after diagnosis (HIV infection diagnosed and confirmed by molecular methods in 2 different samples, i.e., positive qualitative HIV DNA/RNA test).
2. Breastfed-infected children found to be infected ≤ 90 days of age and who started ART at < 90 days after diagnosis. This group will be younger than six months of age at ART initiation.
3. Caregivers (mother, if alive and available) able to provide informed consent.
4. Able to take ART.

Exclusion criteria

1. Second and successive RNA PCR negative
2. Malignancy
3. Current concomitant immunosuppressive therapy (including>15 days and >2 mg/kg/day of prednisone-equivalent).
4. Caregivers withdraw consent
5. Age >180 days.

Trial design

220 participants in 1 patient group

Infants infected through breast-feeding and perinatally

Description:

Infants infected through breast-feeding and perinatally diagnosed with HIV ≤90 days of age and starting ART ≤90 days after diagnosis. For these patients clinical data and blood for viral load, immunology and serology will be collected in the 11 visits.

Treatment:

Procedure: Blood samples collection