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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 September 2023
• Main ID: NCT02043418
• Date of registration: 21/01/2014
• Prospective Registration: No
• Primary sponsor: ANRS, Emerging Infectious Diseases
• Public title: Outcome at 5 Years of Early Treated HIV Infected Infants in the PEDIACAM Project PEDIACAM
• Scientific title: Outcome at 5 Years of Early Treated HIV Infected Infants on Antiretroviral Multi-therapy in the PEDIACAM ANRS12140 Project in Cameroon
• Date of first enrolment: November 2007
• Target sample size: 460
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02043418
• Study type: Observational

Countries of recruitment

Cameroon

Contacts

• Name: Mathurin Tejiokem, Dr
• Affiliation: Centre Pasteur du Cameroun

• Name: Albert Faye, Pr
• Affiliation: Hopital Universitaire Robert-Debre

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 5 Years
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Primary Outcome(s)

Number of clinical/biological events related to HIV infection [Time Frame: 5 years]

Secondary Outcome(s)

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

Survival of infants [Time Frame: 5 years]

Age at switch to second line of ARV treatment [Time Frame: 5 years]

Clinical and immunovirological response to treatment [Time Frame: 5 years]

Regularity of consultations and relationship of the person bringing the child to consultation. [Time Frame: 5 years]

Death of parent or sibling [Time Frame: 5 years]

Number clinical/biological events grade 3 or higher and their potential relationship to ARV therapy, HIV infection or vaccines [Time Frame: 5 years]

Changes in living situation. [Time Frame: 5 years]

Emergence of genotypic mutations of viral resistance to treatment in infants with virologic failure [Time Frame: 5 years]

Secondary ID(s)

ANRS 12140 -12225

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre Pasteur du Cameroun

Centre Hospitalier D'essos

Centre Mère et Enfant de la Fondation Chantal Biya

Assistance Publique - Hôpitaux de Paris

Hospital General De Douala

Institut National de la Santé Et de la Recherche Médicale, France

Institut Pasteur