HIV InfectionsPediacamNEGNCT06302933
Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
A study testing Blood sampling in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 3 sites in Cameroon.
Trial summary
The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon The hypothesis of better control of HIV infection through… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 3 sitesCameroon
- Study dates
- 2 May 2024to 30 Aug 2025
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Case control study
- Children included and followed in the ANRS 12225 study - Pediacam III
- Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.
- Control (4 groups)
- HIV-infected children with positive serology and viral load (VL) <400 copies /ml
- HIV-infected children with positive serology and VL ≥400 copies / ml
Show all 11Show fewer
- HIV-uninfected children born to HIV-positive mothers
- HIV-uninfected children born to HIV-uninfected mothers Selection of cases and controls will be matched on gestational age (premature <37, term ≥37 weeks) and year of birth (2007-2008 and 2009-2010).
- Cross sectional study Inclusion criteria
- All children still followed in the ANRS - Pediacam III cohort
- Written consent of one of the parents or the guardian and assent of the child if aged ≥ 11 years and complete disclosure of HIV statusfor infected children for participation to the study.
Who cannot join
- Refusal by one of the parents or the guardian for the child's participation in the study
- No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)
Trial locations and contacts
3 sites in 1 country.
Cameroon3 sites, 3 recruiting
- Not yet recruiting
Hôpital de Jour - Hôpital Laquintinie de Douala
Douala, 4035
Astrid Moukoko, Dr, 00237699 14 90 47, astridmoukoko@gmail.com
- Recruiting
Unité Pédiatrique de Jour - Centre Mère et Enfant de la Fondation Chantal Biya
Yaoundé, 1274
Francis A Ndongo, Dr, 00237 677 33 00 55, atebfranc@gmail.com
- Recruiting
Service de Pédiatrie - Centre Hospitalier d'Essos
Yaoundé, 5777
Suzie T Ndiang, Dr, 00237 679 53 86 71, ndiangsuzie@yahoo.fr
About this study
The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon
The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:
- Immunological aspect: lack of humoral response or immune activation
- Virological aspect: Reduced HIV reservoir size
- Determine the HLA phenotype in the different groups of children included and the KIR genotypes.
Read the detailed description
There will be two phases of the study :
- A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
- A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank
- Conditions
- HIV Infections
- Being tested
- Blood sampling
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood samples collected from children followed in the Pediacam III ANRS12225 cohort
| Study group | Role | What they receive |
|---|---|---|
| Children enrolled in Pediacam III ANRS12225 cohort | Other | Not described Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of sCD14 (µg/ml). Levels of these biomarkers will be compared across all groups.
Measured: 18 months
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of BAFF using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.
Measured: 18 months
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of CXCL13 using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.
Measured: 18 months
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of TNF-α (pg/ml). Levels of these biomarkers will be compared across all groups.
Measured: 18 months
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of IL-10 (pg/ml). Levels of these biomarkers will be compared across all groups.
Measured: 18 months
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of IP-10 (pg/ml). Levels of these biomarkers will be compared across all groups.
Measured: 18 months
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Measure of TRAIL (ng/ml). Levels of these biomarkers will be compared across all groups
Measured: 18 months
Secondary outcomes (6)
- Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B
Serum concentrations of human IgG antibodies against tetanus-toxoid, pertussis, and viral hepatitis B will be measured using commercially available ELISA quantification kits and results will be given as IU/mL
Measured: 18 months
- Functional and phenotypic characterization of B and T lymphocytes
Level (cells/μL or percentage) of T and B-cell lymphocytes subpopulations will be assess in blood using flow cytometry. Functional characterization of T and B lymphocytes will be done by cell culture following by cytokine production titration
Measured: 18 months
- Size of the HIV reservoir
Measure total (copies/million PBMC), integrated (copies/million PBMC), unintegrated (copies/million PBMC) HIV DNA level in Peripheral Blood Mononuclear Cells (PBMC)
Measured: 18 months
- Residual viremia in perinatally HIV-infected adolescent
Any detectable HIV-RNA below 50 copies/mL
Measured: 18 months
- Level of HIV plasma p24
Measure plasma level of HIV p24 antigen (fg/ml) using ultrasentsitive technique called Simoa (Single molecule array)
Measured: 18 months
- HLA phenotype and the KIR genotypes
HLA-B (27 et 57), HLA-B35 ou 53, HLA-C16:01+KIR2DL3+
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 May 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
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.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study type: a study nested in the ANRS 12225 - Pediacam III cohort, comprising two phases * A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years. * A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank
- Masking
- None (open label)
- Enrolment
- 451 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Centre Pasteur du Cameroun, Centre Mère et Enfant de la Fondation Chantal Biya, Centre Hospitalier D'essos, Hospital General De Douala, CH Orléans, Institut Pasteur, Hopital Universitaire Robert-Debre, Université Paris-Sud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302933
- Sponsor's protocol ID
- ANRS 12414 PediacamNEG
- Acronym
- PediacamNEG
- Status last verified
- Jun 2024
- First submitted
- 24 Aug 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Serology by Immunoenzymatic Test (EIA) in HIV-infected Children Treated Early With Antiretroviral in the ANRS-Pediacam Study: Pathophysiological Mechanisms
- ClinicalTrials.gov ID
- NCT06302933
- Acronym / sponsor ID
- PediacamNEG / ANRS 12414 PediacamNEG
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 451 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Centre Pasteur du Cameroun, Centre Mère et Enfant de la Fondation Chantal Biya, Centre Hospitalier D'essos, Hospital General De Douala, CH Orléans, Institut Pasteur, Hopital Universitaire Robert-Debre, Université Paris-Sud
- Study start
- 2 May 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 12 Mar 2024 (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.
The objective of the study is to identify the pathophysiological mechanisms responsible for the induction and maintenance of negative serologies by EIA tests in HIV-infected children treated early with HAART in the ANRS 12225-Pediacam III cohort in Cameroon
The hypothesis of better control of HIV infection through interactions between immunological, viral, and genetic factors was made to build the following objectives:
- Immunological aspect: lack of humoral response or immune activation
- Virological aspect: Reduced HIV reservoir size
- Determine the HLA phenotype in the different groups of children included and the KIR genotypes.
Detailed description
There will be two phases of the study :
- A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years.
- A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study type: a study nested in the ANRS 12225 - Pediacam III cohort, comprising two phases * A retrospective phase: case-control study The analyzed data are those collected previously or measured from the already available bio bank, within the framework of the Pediacam III cohort during the primary infection phase before the initiation of HAART, at 6 months after the end of the first series of EPI vaccines, and at 2 years. * A prospective phase: cross-sectional study Based on an ad hoc bio bank created for parameters we couldn't measure on the existing bio bank
| Arm | Type | Receives |
|---|---|---|
| Children enrolled in Pediacam III ANRS12225 cohort | Other | Biological: Blood sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Case control study
- Children included and followed in the ANRS 12225 study - Pediacam III
- Having plasma samples in the bio bank during the above-mentioned periods Case:children with at least one negative HIV serology made by ELISA, permanent or transientduring follow-up.
- Control (4 groups)
- HIV-infected children with positive serology and viral load (VL) <400 copies /ml
Key exclusion criteria (2 listed)
- Refusal by one of the parents or the guardian for the child's participation in the study
- No assent of the child (if aged ≥ 11 years and with complete disclosure of HIV status, for infected children)
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 samplingBlood samples collected from children followed in the Pediacam III ANRS12225 cohort | Biological | Children enrolled in Pediacam III ANRS12225 cohort |
Primary outcome
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of sCD14 (µg/ml). Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of BAFF using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of CXCL13 using luminex or commercially available ELISA quantification kits. Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of TNF-α (pg/ml). Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of IL-10 (pg/ml). Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of IP-10 (pg/ml). Levels of these biomarkers will be compared across all groups.
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma
Time frame: 18 months
Measure of TRAIL (ng/ml). Levels of these biomarkers will be compared across all groups
6 secondary outcomes
- Humoral response to vaccines against tetanus, pertussis, and viral hepatitis B
Time frame: 18 months
- Functional and phenotypic characterization of B and T lymphocytes
Time frame: 18 months
- Size of the HIV reservoir
Time frame: 18 months
- Residual viremia in perinatally HIV-infected adolescent
Time frame: 18 months
- Level of HIV plasma p24
Time frame: 18 months
- HLA phenotype and the KIR genotypes
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 3 sites in Cameroon.
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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Cameroon. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathurin C Tejiokem, Doctor (00237222231803, tejiokem@pasteur-yaounde.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pro-inflammatory and anti-inflammatory cytokines, chimiokines in the plasma (time frame: 18 months). The study lists 7 primary outcomes in all. 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 Jan 2025.