Early Anti-Retroviral Treatment in HIV- Infected Children

NCT05784584 | Completed

• 1 other identifier: EARTH
• Study Type: observational
• Target: 220
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

HIV Infections

Keywords

HIV; Infection; Infants; Antiretroviral Therapy

Outcome Measures

Primary Outcomes (1)

• 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: 1. Undetectable HIV RNA viral load in peripheral blood in the last year (blips, spikes and suboptimal viral control allowed, see below for definitions), 2. Reservoir size (Total DNA /million PBMC) below 25th percentile with ddPCR / IPDA. 3. Good immunological control (defined as a CD4 \>30% and a good NK or CTL response) during the last year

  4 years

Study Arms (1)

Infants infected through breast-feeding and perinatally

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.

Procedure: Blood samples collection

Interventions

Blood samples collection PROCEDURE

The study population will take blood samples for virological and immunological measurements.

Infants infected through breast-feeding and perinatally

Eligibility Criteria

• Age: Up to 180 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Perinatally infected infants who begin ART ≤ 90 days after diagnosis. Breastfed infants diagnosed with HIV ≤90 days of age and starting ART ≤ 90 days after diagnosis. The diagnosis of HIV transmission by breastmilk will be made from infants who: 1. Have a negative birth HIV PCR 2. Are being breastfed 3. Who subsequently have 2 molecular methods positive for HIV. These tests will be conducted selectively among participants with a clinical evaluation suggestive of HIV infection, at the discretion of the attending physician.

You may qualify if:

• 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).
• 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.
• Caregivers (mother, if alive and available) able to provide informed consent.
• Able to take ART.

You may not qualify if:

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

Sponsors & Collaborators

• PENTA Foundation: lead

Study Sites (6)

Centre Hospitalier Universitaire Gabriel Touré

Bamako, Mali

Location

Centro de Investigaçao em Saude de Manhiça

Manica, Mozambique

Location

Fundação Ariel Glaser contra o SIDA Pediátrico

Maputo, Mozambique

Location

Tygerberg Children's Hospital (TCH)

Cape Town, South Africa

Location

Africa Health Research Institute (AHRI)

Durban, South Africa

Location

PHRU

Soweto, South Africa

Location

MeSH Terms

Conditions

HIV Infections; Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Alfredo Tagarro, MD

  Fundación Investigación Hospital 12 de Octubre

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 27, 2023
• Study Start: May 1, 2018
• Primary Completion: February 28, 2024
• Study Completion: March 28, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

MO (2); ZA (3); MA (1)