Early Anti-Retroviral Treatment in HIV- Infected Children

NCT ID: NCT05784584

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2024-03-28

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.

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

Keywords

HIV; Infection; Infants; Antiretroviral Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood samples collection

Intervention Type: PROCEDURE

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

Interventions

Blood samples collection

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Maximum Eligible Age: 180 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PENTA Foundation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfredo Tagarro, MD

Role: STUDY_CHAIR

Fundación Investigación Hospital 12 de Octubre

Locations

Centre Hospitalier Universitaire Gabriel Touré

Bamako, , Mali

Centro de Investigaçao em Saude de Manhiça

Manica, , Mozambique

Fundação Ariel Glaser contra o SIDA Pediátrico

Maputo, , Mozambique

Tygerberg Children's Hospital (TCH)

Cape Town, , South Africa

Africa Health Research Institute (AHRI)

Durban, , South Africa

PHRU

Soweto, , South Africa

Countries

Mali; Mozambique; South Africa

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EARTH

Identifier Type: -

Identifier Source: org_study_id