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

HIV Clinical Trial

— PediacamDEV  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02570334
• Other study ID #: ANRS 12322 PediacamDEV
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2015
• Last updated: July 11, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: Mathurin Cyrille TEJIOKEM, MD, PhD
• Phone: 222 22 23 10 15
• Email: tejiokem[@]pasteur-yaounde.org
• Is FDA regulated: No
• Health authority: Cameroon: Division of Health Operations Research
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 7 Years

Eligibility

Inclusion Criteria:

• Children included in the Pediacam cohort and age 4 to 7

• Parent or guardian written informed consent obtained

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Children Exposed to HIV
• HIV
• HIV-uninfected Children

Intervention

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.

Locations

Country	Name	City	State
Cameroon	Hôpital de Laquintinie	Douala
Cameroon	Centre Hospitalier d'Essos	Yaounde
Cameroon	Hôpital de la Fondation Mère-enfant Chantal Biya	Yaounde

Sponsors (8)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Centre Hospitalier D'essos, Centre Mère et Enfant de la Fondation Chantal Biya, Centre Pasteur du Cameroun, Hospital General De Douala, Inserm U1018, Equipe 4 VIH & IST, Institut de Recherche pour le Developpement, Robert Debré Hospital

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	4-7 years of age	No
Secondary	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	4-7 years of age	No
Secondary	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	4-7 years of age	No