Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02570334
Recruitment Status : Unknown
Verified July 2016 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Recruiting
First Posted : October 7, 2015
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
Centre Pasteur du Cameroun
Robert Debré Hospital
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
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.

Condition or disease Intervention/treatment Phase
HIV HIV-uninfected Children Children Exposed to HIV Other: HIV-infected children initiated antiretroviral treatment within the first 7 months of life Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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)
Study Start Date : December 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: HIV-infected children diagnosed before 7 months of life
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.




Primary Outcome Measures :
  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 [ 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02570334


Contacts
Layout table for location contacts
Contact: Mathurin Cyrille TEJIOKEM, MD, PhD 222 22 23 10 15 ext 237 tejiokem@pasteur-yaounde.org

Locations
Layout table for location information
Cameroon
Hôpital de Laquintinie Recruiting
Douala, Cameroon
Contact: Ida Penda, Dr       idapenda@yahoo.fr   
Centre Hospitalier d'Essos Recruiting
Yaounde, Cameroon
Contact: Suzie Tetang Ndiang       ndiangsuzie@yahoo.fr   
Hôpital de la Fondation Mère-enfant Chantal Biya Recruiting
Yaounde, Cameroon
Contact: Francis Ateba, Dr       atebfranc@gmail.com   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Centre Pasteur du Cameroun
Robert Debré Hospital
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

Layout table for additonal information
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02570334    
Other Study ID Numbers: ANRS 12322 PediacamDEV
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
early ART
neurocognitive evaluation
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents