HIV InfectionsNCT05784584
Early Anti-Retroviral Treatment in HIV- Infected Children
An observational study of HIV Infections, run by PENTA Foundation at 6 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages Up to 180 days
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood samples collection
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 May 2018to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 180 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
South Africa3 sites
Tygerberg Children's Hospital (TCH)
Cape Town
Africa Health Research Institute (AHRI)
Durban
PHRU
Soweto
Mozambique2 sites
Centro de Investigaçao em Saude de Manhiça
Manica
Fundação Ariel Glaser contra o SIDA Pediátrico
Maputo
About this study
Official title: A Prospective, Observational, Cohort, Multicenter Study of Early Anti-Retroviral Treatment in HIV- Infected Infants
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.
Read the 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
- Being tested
- Blood samples collection
- Keywords
- HIV, Infection, Infants, Antiretroviral Therapy
- Medical subject headings
- HIV Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples collectionProcedure or surgery
The study population will take blood samples for virological and immunological measurements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 May 2018
- Primary completion28 Feb 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- PENTA Foundation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alfredo Tagarro, MD, Study chair, Fundación Investigación Hospital 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784584
- Sponsor's protocol ID
- EARTH
- Status last verified
- Dec 2024
- First submitted
- 2 Mar 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Cohort, Multicenter Study of Early Anti-Retroviral Treatment in HIV- Infected Infants
- ClinicalTrials.gov ID
- NCT05784584
- Acronym / sponsor ID
- EARTH
- Conditions
- HIV Infections
- Keywords
- HIV, Infection, Infants, Antiretroviral Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- PENTA FoundationResearch network
- Study start
- 1 May 2018 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants infected through breast-feeding and perinatally | – | Procedure: Blood samples collectionInfants 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. |
Who may qualify
- Ages
- Up to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples collectionThe study population will take blood samples for virological and immunological measurements. | Procedure or surgery | Infants infected through breast-feeding and perinatally |
Primary outcome
Proportion of children with excellent HIV control
Time frame: 4 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfredo Tagarro, MD study chair
Fundación Investigación Hospital 12 de Octubre
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by PENTA Foundation at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Africa, Mozambique, Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children with excellent HIV control (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.