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Outcome at 5 Years of Early Treated HIV Infected Infants in the PEDIACAM Project (PEDIACAM)

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ClinicalTrials.gov Identifier: NCT02043418
Recruitment Status : Active, not recruiting
First Posted : January 23, 2014
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims to assess the long-term outcomes of children infected with HIV, having participated in the ANRS 12140 PediacamI study, in terms of: clinical and immunovirological response to ARV therapy, long-term ARV tolerance, and the impact of family environment and lifestyle on adherence to ARV treatment.

Condition or disease
HIV

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 460 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome at 5 Years of Early Treated HIV Infected Infants on Antiretroviral Multi-therapy in the PEDIACAM ANRS12140 Project in Cameroon
Study Start Date : November 2007
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
children VIH+
children infected with HIV
Chlidren VIH-
uninfected children born from HIV-positive or HIV-negative mothers


Outcome Measures

Primary Outcome Measures :
  1. Number of clinical/biological events related to HIV infection [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Number clinical/biological events grade 3 or higher and their potential relationship to ARV therapy, HIV infection or vaccines [ Time Frame: 5 years ]
  2. Emergence of genotypic mutations of viral resistance to treatment in infants with virologic failure [ Time Frame: 5 years ]
    Virologic failure is defined by a value of viral load > 400 copies / ml measured by RT-PCR after 6 months of treatment

  3. Survival of infants [ Time Frame: 5 years ]
  4. Age at switch to second line of ARV treatment [ Time Frame: 5 years ]
    The duration of therapy without changes in treatment will also be monitored.

  5. Clinical and immunovirological response to treatment [ Time Frame: 5 years ]
    Success is defined as viral load < 400 copies/ml and a rise in CD4 count of at least 20% at 6 months of treatment, and no recorded drops in CD4 counts of more than 25%

  6. Regularity of consultations and relationship of the person bringing the child to consultation. [ Time Frame: 5 years ]
  7. Death of parent or sibling [ Time Frame: 5 years ]
  8. Changes in living situation. [ Time Frame: 5 years ]
    Changes of address and living space, separation of parents, changes of members of the family living with the infant (siblings, cousins, uncles, grandparents), transfer of the infant to public institutions or adoption, will all be monitored in the scheduled visits throughout the 5 year follow-up.

  9. Communication of child's HIV status to family and community [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
a biobank (plasma / serum stored at -80 ° C) will be established

Eligibility Criteria

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children
Criteria

Inclusion Criteria:

  • infants having participated in the ANRS 12140 PEDIACAM study
  • HIV+ or HIV-
  • signed consent
  • born from HIV+ mothers having received perinatal ARV therapy or not
  • or HIV- mothers

Exclusion Criteria:

  • unsigned consent form
Contacts and Locations

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): NCT02043418


Locations
Cameroon
Hôpital Laquintinie
Douala, Cameroon
Centre Hospitalier d'Essos
Yaounde, Cameroon
Centre Mère et Enfant de la Fondation Chantal Biya
Yaounde, Cameroon
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
Centre Mère et Enfant de la Fondation Chantal Biya
Centre Hospitalier D'essos
Hospital General De Douala
Institut Pasteur de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Mathurin Tejiokem, Dr Centre Pasteur du Cameroun
Principal Investigator: Albert Faye, Pr Robert Debré Hospital
More Information

Additional Information:
Publications:
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: NCT02043418     History of Changes
Other Study ID Numbers: ANRS 12140 -12225
First Posted: January 23, 2014    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):
HIV
ARV
Pediatric
Cameroon