NCT02570334

Brief 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 age at ARV initiation and (2) HIV exposed but not infected children, all compared with the control group of children uninfected, unexposed to HIV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

10 months

First QC Date

October 6, 2015

Last Update Submit

July 11, 2016

Conditions

HIVHIV-uninfected ChildrenChildren Exposed to HIV

Keywords

early ARTneurocognitive evaluation

Outcome Measures

Primary Outcomes (1)

  • 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

    4-7 years of age

Secondary Outcomes (3)

  • Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children

    4-7 years of age

  • Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments

    4-7 years of age

  • Prognostic factors and consequences of HIV-associated neuro-cognitive impairments

    4-7 years of age

Study Arms (3)

HIV-infected children diagnosed before 7 months of life

EXPERIMENTAL

HIV-infected children diagnosed before 7 months of life

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

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

Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life

Interventions

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.

HIV-exposed uninfected childrenHIV-infected children diagnosed before 7 months of lifeHIV-unexposed uninfected children

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital de Laquintinie

Douala, Cameroon

RECRUITING

Centre Hospitalier d'Essos

Yaoundé, Cameroon

RECRUITING

Hôpital de la Fondation Mère-enfant Chantal Biya

Yaoundé, Cameroon

RECRUITING

Central Study Contacts

Mathurin Cyrille TEJIOKEM, MD, PhD

CONTACT

222 22 23 10 15tejiokem@pasteur-yaounde.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 7, 2015

Study Start

December 1, 2015

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

CA(3)