HIVPediacamDEVNCT02570334
A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)
A study testing HIV-infected children initiated antiretroviral treatment within the first 7 months of life in people with HIV and HIV-uninfected Children, run by ANRS, Emerging Infectious Diseases at 3 sites in Cameroon.
Trial summary
This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to provide complementary information to the trials CHER and PREDICT on the long term development of (1) HIV-infected children according to… Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- HIV, HIV-uninfected Children, Children Exposed to HIV
- What is being tested?
- HIV-infected children initiated antiretroviral treatment within the first 7 months of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesCameroon
- Study dates
- Dec 2015to Dec 2016
- 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 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children included in the Pediacam cohort and age 4 to 7
- Parent or guardian written informed consent obtained
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Cameroon3 sites, 3 recruiting
- Recruiting
Hôpital de Laquintinie
Douala
Ida Penda, Dr, idapenda@yahoo.fr
- Recruiting
Centre Hospitalier d'Essos
Yaoundé
Suzie Tetang Ndiang, ndiangsuzie@yahoo.fr
- Recruiting
Hôpital de la Fondation Mère-enfant Chantal Biya
Yaoundé
Francis Ateba, Dr, atebfranc@gmail.com
About this study
This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to provide complementary information to the trials CHER and PREDICT on the long term development of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not infected children, all compared with the control group of children uninfected, unexposed to HIV.
Read the detailed description
Cognitive, motor and sensorial impairments associated to HIV infection have been and remain important concerns in children. The advent of ARV has reduced the frequency and the extent of HIV-related encephalopathys, but literature suggests that more limited impairments remain (CHER and PREDICT trials). These neuro-cognitive disorders might constitute an important public health problem in sub-Saharan Africa where a high percentage of children born to HIV+ women live. Nevertheless,the knowledge on their long-term consequences on children development in this context remains limited. Data on the burden of cognitive, motor and sensorial impairment in resource-limited settings as well as on the interaction with other factors that could also impair children development are scarse.
The Pediacam cohort gives the opportunity to better understand the development of children born to HIV-infected mothers - infected by HIV or not - followed up from birth and living in sub-Saharan Africa.
- Conditions
- HIV, HIV-uninfected Children, Children Exposed to HIV
- Being tested
- HIV-infected children initiated antiretroviral treatment within the first 7 months of life
- Keywords
- early ART, neurocognitive evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV-infected children initiated antiretroviral treatment within the first 7 months of lifeOther
All arms will recieve a thourough clinical evaluation : Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments as well as a questionnaire concerning socioeconomic situation, medical history of the child and mother, and HIV treatment and follow up information.
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected children diagnosed before 7 months of life | Experimental | HIV-infected children diagnosed before 7 months of life Receives: Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life |
| HIV-exposed uninfected children | Experimental | HIV-uninfected children born to HIV-infected mothers Receives: Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life |
| HIV-unexposed uninfected children | Experimental | Children born to HIV-uninfected mothers Receives: Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments
Frequency of cognitive, motor and sensorial impairments in 4-7 year old children born to HIV+ mothers who received early treatment in the first 7 months of life
Measured: 4-7 years of age
Secondary outcomes (3)
Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children
long term effect of HIV and/or PMTCT exposure on children exposed but not infected with HIV. Results of cognitive, motor and sensorial (hearing and visual) evaluations will be compared among cohorts.
Measured: 4-7 years of age
Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments
long term effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on cognitive, motor and sensorial impairments in HIV+ children
Measured: 4-7 years of age
Prognostic factors and consequences of HIV-associated neuro-cognitive impairments
prognostic factors and describe consequences of HIV-associated neuro-cognitive impairments on children social life
Measured: 4-7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Centre Pasteur du Cameroun, Hopital Universitaire Robert-Debre, Institut de Recherche pour le Developpement, Centre Mère et Enfant de la Fondation Chantal Biya, Hospital General De Douala, Centre Hospitalier D'essos, Inserm U1018, Equipe 4 VIH & IST
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570334
- Sponsor's protocol ID
- ANRS 12322 PediacamDEV
- Acronym
- PediacamDEV
- Status last verified
- Jul 2016
- First submitted
- 6 Oct 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)
- ClinicalTrials.gov ID
- NCT02570334
- Acronym / sponsor ID
- PediacamDEV / ANRS 12322 PediacamDEV
- Conditions
- HIV, HIV-uninfected Children, Children Exposed to HIV
- Keywords
- early ART, neurocognitive evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Centre Pasteur du Cameroun, Hopital Universitaire Robert-Debre, Institut de Recherche pour le Developpement, Centre Mère et Enfant de la Fondation Chantal Biya, Hospital General De Douala, Centre Hospitalier D'essos, Inserm U1018, Equipe 4 VIH & IST
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- 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.
This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to provide complementary information to the trials CHER and PREDICT on the long term development of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not infected children, all compared with the control group of children uninfected, unexposed to HIV.
Detailed description
Cognitive, motor and sensorial impairments associated to HIV infection have been and remain important concerns in children. The advent of ARV has reduced the frequency and the extent of HIV-related encephalopathys, but literature suggests that more limited impairments remain (CHER and PREDICT trials). These neuro-cognitive disorders might constitute an important public health problem in sub-Saharan Africa where a high percentage of children born to HIV+ women live. Nevertheless,the knowledge on their long-term consequences on children development in this context remains limited. Data on the burden of cognitive, motor and sensorial impairment in resource-limited settings as well as on the interaction with other factors that could also impair children development are scarse.
The Pediacam cohort gives the opportunity to better understand the development of children born to HIV-infected mothers - infected by HIV or not - followed up from birth and living in sub-Saharan Africa.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV-infected children diagnosed before 7 months of life | Experimental | Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of lifeHIV-infected children diagnosed before 7 months of life |
| HIV-exposed uninfected children | Experimental | Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of lifeHIV-uninfected children born to HIV-infected mothers |
| HIV-unexposed uninfected children | Experimental | Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of lifeChildren born to HIV-uninfected mothers |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children included in the Pediacam cohort and age 4 to 7
- Parent or guardian written informed consent obtained
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HIV-infected children initiated antiretroviral treatment within the first 7 months of lifeAll arms will recieve a thourough clinical evaluation : Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments as well as a questionnaire concerning socioeconomic situation, medical history of the child and mother, and HIV treatment and follow up information. | Other | HIV-exposed uninfected children, HIV-infected children diagnosed before 7 months of life, HIV-unexposed uninfected children |
Primary outcome
Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments
Time frame: 4-7 years of age
Frequency of cognitive, motor and sensorial impairments in 4-7 year old children born to HIV+ mothers who received early treatment in the first 7 months of life
3 secondary outcomes
Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children
Time frame: 4-7 years of age
Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments
Time frame: 4-7 years of age
Prognostic factors and consequences of HIV-associated neuro-cognitive impairments
Time frame: 4-7 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
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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 HIV-infected children initiated antiretroviral treatment within the first 7 months of life in people with HIV and HIV-uninfected Children, 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 2 inclusion and 1 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 12 Jul 2016. 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 Cyrille TEJIOKEM, MD, PhD (222 22 23 10 15 ext. 237, tejiokem@pasteur-yaounde.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments (time frame: 4-7 years of age). 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 12 Jul 2016.