A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam) (PediacamDEV)

July 11, 2016 updated by: ANRS, Emerging Infectious Diseases
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Cameroon
      • Douala, Cameroon
      • Yaounde, Cameroon
      • Yaounde, Cameroon
        • Recruiting
        • Hôpital de la Fondation Mère-enfant Chantal Biya
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children included in the Pediacam cohort and age 4 to 7
  • Parent or guardian written informed consent obtained

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV-infected children diagnosed before 7 months of life
Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life
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.
Experimental: HIV-exposed uninfected children
HIV-uninfected children born to HIV-infected mothers
Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life
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.
Experimental: HIV-unexposed uninfected children
Children born to HIV-uninfected mothers
Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4-7 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children
Time Frame: 4-7 years of age
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.
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
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
4-7 years of age
Prognostic factors and consequences of HIV-associated neuro-cognitive impairments
Time Frame: 4-7 years of age
prognostic factors and describe consequences of HIV-associated neuro-cognitive impairments on children social life
4-7 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Hopital Universitaire Robert-Debre
Institut de Recherche pour le Developpement
Centre Pasteur du Cameroun
Centre Mère et Enfant de la Fondation Chantal Biya
Centre Hospitalier D'essos
Hospital General De Douala
Inserm U1018, Equipe 4 VIH & IST

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS 12322 PediacamDEV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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