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

This study is ongoing, but not recruiting participants.
Sponsor:
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)
ClinicalTrials.gov Identifier:
NCT02043418
First received: January 21, 2014
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

Assess the long-term outcomes of children infected with HIV in terms of: clinical and and immunovirological response to ARV therapy, long-term ARV tolerance, and the impact of family environment and lifestyle on adherence to ARV treatment.


Condition
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome at 5 Years of Early Treated HIV Infected Infants With Antiretroviral Multi-therapy in the PEDIACAM ANRS12140 Project in Cameroon

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • Number of clinical/biological events related to HIV infection [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

  • Survival of infants [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Age at switch to second line of ARV treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The duration of therapy without changes in treatment will also be monitored.

  • Clinical and immunovirological response to treatment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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%

  • Regularity of consultations and relationship of the person bringing the child to consultation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Death of parent or sibling [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Changes in living situation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.

  • Communication of child's HIV status to family and community [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

a biobank (plasma / serum stored at -80 ° C) will be established


Estimated Enrollment: 340
Study Start Date: November 2007
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
children VIH+
children infected with HIV
Chlidren VIH-
uninfected children born from HIV-positive or HIV-negative mothers

Detailed Description:

The follow-up of HIV infected children is an important part of their access to antiretroviral drugs. This therapeutic follow-up has an impact on infant morbidity and mortality and remains challenging due to its complexity (multi-drug therapy), the use of galenic forms that are not well adapted to children, the risks of toxicity and their prolonged administration, and the evolution of this syndrome in the patients' parents. Currently, while access to ARV is being ameliorated for children in Sub-Saharan Africa, little information is available on medium to long-term evolution of early treated HIV infected infants on ARV treatment. In Cameroon, the PEDIACAM ANRS12140 study has assessed for a period of 2 years, the impact of early ARV treatment in HIV infected children and their humoral responses to EPI vaccines. The prolongation to 5 years of follow-up of these children, including HIV non-infected children is a unique opportunity to describe in terms of medium to long-term response: the clinical and immunovirological prognosis of the HIV infection in children and to identify factors associated with treatment failure.

This is a prospective longitudinal, observational, national multi-centred study including two groups of infants: one group of HIV infected infants treated early, and one group of HIV non-infected infants (born to either HIV infected or HIV non-infected mothers). Participation in the study will be proposed to all the infants included in PEDIACAM ANRS12140, if possible before the age of 2 years. Only children whose parents or legal guardians consent to this continuation of the follow-up will be included. The children participating in the study will be followed up every 6 months until the age of 5 years (duration of prolongation of study is 3 years). In the course of each visit, a clinical examination will be carried out as well as a complete laboratory examination. Antiretroviral treatment will be in line with the national recommendations and guidelines. The PEDIACAM ANRS12225 two year follow-up concerns 340 children divided into 200 non-infected infants and 140 HIV positive infants. Population size has been calculated taking into account possible deaths, loss to follow-up and refusal to participate.

This cohort will enable us to answer the questions that arise regarding the long-term outcomes of HIV infected children in terms of clinical prognosis and immunology, and the impact of family environment and lifestyle on ARV treatment adherence. It will also aid in structuring the follow-up of children treated with ARVs in Cameroon. Furthermore, a study on the response to vaccines will enable the identification of possible failures and to propose, if necessary, an adjustment of the vaccine calendar.

  Eligibility

Ages Eligible for Study:   up to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children

Criteria

Inclusion Criteria:

  • infants < 7 months
  • HIV+ or HIV-
  • signed consent
  • born from HIV+ mothers having recieved perinatal ARV therapy or not
  • or HIV- mothers

Exclusion Criteria:

  • unsigned consent form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043418

Locations
Cameroon
Hôpital Laquintinie
Douala, Cameroon
Centre Mère et Enfant de la Fondation Chantal Biya
Yaounde, Cameroon
Centre Hospitalier d'Essos
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)
Investigators
Principal Investigator: Mathurin Tejiokem, Dr Centre Pasteur du Cameroun
Principal Investigator: Albert Faye, Pr Hôpital Robert Debré
  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
Study First Received: January 21, 2014
Last Updated: January 23, 2014
Health Authority: Cameroon: Ministry of Public Health

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
Cameroun

ClinicalTrials.gov processed this record on April 15, 2014