NCT05784584Completed
Early Anti-Retroviral Treatment in HIV- Infected Children
A Prospective, Observational, Cohort, Multicenter Study of Early Anti-Retroviral Treatment in HIV- Infected Infants
Source: ClinicalTrials.gov · Last updated 30 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 220 (actual)
- First submitted
- 2 Mar 2023
- Start date
- 1 May 2018
- Primary completion date
- 28 Feb 2024
- Lead sponsor
- PENTA Foundation
- Diseases
- HIV
- NCT number
- NCT05784584
What you commit to
- Study type: Observational
- Participants enrolled: 220
- From 1 May 2018 to the primary completion date, 28 Feb 2024
- 6 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current concomitant immunosuppressive therapy (including\>15 days and \>2 mg/kg/day of prednisone-equivalent).
Other illness
- Malignancy
Age
- Age \>180 days.
Other
- Second and successive RNA PCR negative
- Caregivers withdraw consent
Who the study is looking for
- 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.
Age in the registry: - to 180 days · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire Gabriel Touré Coordinator of this site? Confirm its status | Bamako | Mali | Unknown status |
| Centro de Investigaçao em Saude de Manhiça Coordinator of this site? Confirm its status | Manica | Mozambique | Unknown status |
| Fundação Ariel Glaser contra o SIDA Pediátrico Coordinator of this site? Confirm its status | Maputo | Mozambique | Unknown status |
| Tygerberg Children's Hospital (TCH) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Africa Health Research Institute (AHRI) Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| PHRU Coordinator of this site? Confirm its status | Soweto | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.