Trial record 13 of 36 for:    " January 13, 2014":" February 12, 2014"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  Purpose

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
HIV

Study Type: Observational
Study Design: 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

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: 460
Study Start Date: November 2007
Estimated Study Completion Date: December 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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)
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
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: July 11, 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
Cameroon

ClinicalTrials.gov processed this record on July 29, 2014