Early Anti-Retroviral Treatment in HIV- Infected Children

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05784584
• Other study ID #: EARTH
• Status: Active, not recruiting
• Start date: May 1, 2018
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2023
• Source: PENTA Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 180 Days

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Procedure:
• Blood samples collection
The study population will take blood samples for virological and immunological measurements.

Locations

Country	Name	City	State
Mali	Centre Hospitalier Universitaire Gabriel Touré	Bamako
Mozambique	Centro de Investigaçao em Saude de Manhiça	Manica
Mozambique	Fundação Ariel Glaser contra o SIDA Pediátrico	Maputo
South Africa	Tygerberg Children's Hospital (TCH)	Cape Town
South Africa	Africa Health Research Institute (AHRI)	Durban
South Africa	PHRU	Soweto

Sponsors (1)

Lead Sponsor	Collaborator
PENTA Foundation

Countries where clinical trial is conducted

Mali,  Mozambique,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of children with excellent HIV control	Proportion of children with excellent HIV control profile at 2 and 4 years of age. This excellent control profile includes a composite endpoint of all of the following: Undetectable HIV RNA viral load in peripheral blood in the last year (blips, spikes and suboptimal viral control allowed, see below for definitions),; Reservoir size (Total DNA /million PBMC) below 25th percentile with ddPCR / IPDA.; Good immunological control (defined as a CD4 >30% and a good NK or CTL response) during the last year	4 years