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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Centre Pasteur du Cameroun
Centre Mère et Enfant de la Fondation Chantal Biya
Centre Hospitalier d'Essos à Yaoundé
Hôpital Laquintinie de Douala
Institut Pasteur de Paris
U1018 Inserm
Assistance Publique - Hôpitaux de Paris
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: July 11, 2014
Last verified: July 2014

January 21, 2014
July 11, 2014
November 2007
July 2016   (final data collection date for primary outcome measure)
Number of clinical/biological events related to HIV infection [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02043418 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Communication of child's HIV status to family and community [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Outcome at 5 Years of Early Treated HIV Infected Infants in the PEDIACAM Project
Outcome at 5 Years of Early Treated HIV Infected Infants on Antiretroviral Multi-therapy in the PEDIACAM ANRS12140 Project in Cameroon

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.

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 ANRS 12140 study assessed for a period of 2 years, the impact and feasibility of early ARV treatment in HIV infected children and their humoral responses to EPI vaccines.

This first study (PEDIACAM ANRS 12140) began in November 2007 and consisted of two phases. During the first phase all children born from HIV+ mothers in the maternity wards of the participating hospitals were invited to participate. For every infant born from an HIV+ mother, an infant born from an HIV- mother was matched. A total of 2052 pairs of infants were recruited and they were all followed up to the age of 14 weeks. All infants born from seropositive mothers had a PCR HIV diagnostic test at the age of 6 weeks.

The second phase began after the age of 14 weeks. It consisted of four groups of infants: a group of HIV+ infants born from HIV+ mothers and followed from birth (n=69); a group of HIV- infants born from HIV+ mothers and followed from birth (n=205); a control group including a subset of the HIV- children born from HIV- mothers that had been followed since birth (n=196); and a final group that was added at this phase including HIV+ children that had not been followed up since birth but who had been diagnosed before the age of 7 months at any of the trial sites (n=141). During this phase, children were followed up to the age of 2 years. During these two years (phase I and phase II) the following criteria were evaluated: feasibility of early ARV treatment in infants, treatment tolerance, efficacy and adherence, clinical and immuno-virological prognosis of HIV infection in infants, rate of MTCT according to prevention strategies and humoral response to vaccines,.

The prolongation to 5 years of follow-up of the children participating in Phase II of the study constitutes the present study, ANRS 12225 PEDIACAM II. This follow up includes HIV non-infected children and is a unique opportunity to describe the medium to long-term clinical and immunovirological prognosis of the HIV infection in children and to further identify factors associated with treatment failure.

This second part of PEDIACAM, is a prospective longitudinal, observational, national multi-centered 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 phase II of PEDIACAM ANRS 12140, 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 seen for consultation every 6 months until the last child included reaches the age of 5 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.

Four hundred sixty (460) children including 148 HIV-infected and 312 HIV-uninfected have been included in ANRS 12225 - Pediacam II study. We hypothesize for the next three years follow up period a low rate of missing HIV-infected children (death or loss to follow up) of about 5% and 20% for HIV-uninfected children. With such hypothesis, we will have at the end of the study, information of 140 HIV-infected and 250 HIV-uninfected children for our analysis

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, this study will continue to observe the response to vaccines. It will enable the identification of possible failures in the vaccination program and will enable us to propose, if necessary, an adjustment of the vaccine calendar.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Children

HIV
Not Provided
  • children VIH+
    children infected with HIV
  • Chlidren VIH-
    uninfected children born from HIV-positive or HIV-negative mothers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
460
December 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Cameroon
 
NCT02043418
ANRS 12140 -12225
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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 à Yaoundé
  • Hôpital Laquintinie de Douala
  • Institut Pasteur de Paris
  • U1018 Inserm
  • Assistance Publique - Hôpitaux de Paris
Principal Investigator: Mathurin Tejiokem, Dr Centre Pasteur du Cameroun
Principal Investigator: Albert Faye, Pr Hôpital Robert Debré
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP