NCT02043418

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
11.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

17.7 years

First QC Date

January 21, 2014

Last Update Submit

January 28, 2025

Conditions

HIV

Keywords

HIVARVPediatricCameroon

Outcome Measures

Primary Outcomes (1)

  • Number of clinical/biological events related to HIV infection

    5 years

Secondary Outcomes (9)

  • Number clinical/biological events grade 3 or higher and their potential relationship to ARV therapy, HIV infection or vaccines

    5 years

  • Emergence of genotypic mutations of viral resistance to treatment in infants with virologic failure

    5 years

  • Survival of infants

    5 years

  • Age at switch to second line of ARV treatment

    5 years

  • Clinical and immunovirological response to treatment

    5 years

  • +4 more secondary outcomes

Study Arms (2)

children VIH+

children infected with HIV

Chlidren VIH-

uninfected children born from HIV-positive or HIV-negative mothers

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children

You may qualify if:

  • 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

You may not qualify if:

  • unsigned consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Laquintinie

Douala, Cameroon

Location

Centre Hospitalier d'Essos

Yaoundé, Cameroon

Location

Centre Mère et Enfant de la Fondation Chantal Biya

Yaoundé, Cameroon

Location

Related Publications (3)

  • Kfutwah AK, Tejiokem MC, Ateba FN, Ndongo JA, Penda IC, Ngoupo PA, Tchendjou P, Chewa G, Boisier P, Rouzioux C, Warszawski J, Faye A; ANRS 12140-Pediacam Study Group. Seronegativation in early treated HIV-infected infants: frequency and potential implications on care and follow-up in a resource-limited country. J Acquir Immune Defic Syndr. 2011 Oct 1;58(2):e43-6. doi: 10.1097/QAI.0b013e31822d49f0. No abstract available.

    PMID: 21921727BACKGROUND

  • Tejiokem MC, Faye A, Penda IC, Guemkam G, Ateba Ndongo F, Chewa G, Rekacewicz C, Rousset D, Kfutwah A, Boisier P, Warszawski J; ARNS 12140-PEDIACAM study group. Feasibility of early infant diagnosis of HIV in resource-limited settings: the ANRS 12140-PEDIACAM study in Cameroon. PLoS One. 2011;6(7):e21840. doi: 10.1371/journal.pone.0021840. Epub 2011 Jul 19.

    PMID: 21818273BACKGROUND

  • Sofeu CL, Warszawski J, Ateba Ndongo F, Penda IC, Tetang Ndiang S, Guemkam G, Makwet N, Owona F, Kfutwah A, Tchendjou P, Texier G, Tchuente M, Faye A, Tejiokem MC; ANRS-PEDIACAM Study Group. Low birth weight in perinatally HIV-exposed uninfected infants: observations in urban settings in Cameroon. PLoS One. 2014 Apr 3;9(4):e93554. doi: 10.1371/journal.pone.0093554. eCollection 2014.

    PMID: 24705410RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

  • Mathurin Tejiokem, Dr

    Centre Pasteur du Cameroun

    PRINCIPAL INVESTIGATOR

  • Albert Faye, Pr

    Hopital Universitaire Robert-Debre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 23, 2014

Study Start

November 1, 2007

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations

CA(3)