ANRS 12406 EvvA Study

NCT ID: NCT04593979

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-01-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

ANRS 12406 EvvA is an observational, longitudinal and monocentric study evaluating the virological success rate in HIV-infected adolescents on antiretroviral therapy in Cameroon.

The main objective of the study is to estimate the rate of virological suppression among adolescents on antiretroviral therapy for more than 6 months in Cameroon

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

At the end of 2017, HIV-AIDS affects more than 36 million people worldwide, more than three-quarters of whom live in sub-Saharan Africa, and a quarter of the infections are among young people and adolescents. Every hour, 4 adolescents (aged 15-19) are newly infected with HIV in the world, and 3 of them are adolescents. Three infections occur in sub-Saharan Africa, and for five adolescents living with HIV, there are seven girls (aged 10 to 19) in the same situation. This gender disparity increases when adolescents reach adulthood. This group of the population may well deserve the term "key and vulnerable population". In the era of international commitment to end the AIDS epidemic by 2030, especially to stop new infections, it is essential not to neglect part of the epidemic because it would effectively represent a reservoir for maintaining the epidemic and make these eradication goals impracticable. Data on virological success among adolescents on antiretroviral treatment are generally scarce and this is much more striking in Central Africa. Also, information on the frequency of emergence of resistant viruses and the consequences for the effectiveness of available treatments is rare. However, in the absence of such data, it is difficult, if not impossible, to take the right decisions to improve the care and monitoring of adolescents. In addition, the few available data indicate high virological failure rates and high frequencies of drug resistance, which may indicate a need to further investigate virological failure events in this population.

This study will be conducted in Cameroon among 289 adolescents during 9 months, where access to biological monitoring is a major challenge, especially with low access to viral load testing. The results of this project will inform on the current state of success of ARV treatments in this population. Moreover, the other goal of this study is to conclude on the need to conduct a larger study at the national or regional level according to the results obtained

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV-1-infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being adolescent (aged 10 to 19) on antiretroviral therapy and followed at the Laquintinie Hospital (Douala Cameroon)
* HIV-1 infection
* Duration of antiretroviral therapy ≥ 6 months regardless of antiretroviral regimen
* For emancipated adolescents: obtaining informed consent signed by the adolescent
* For unemancipated adolescents:
* Obtaining informed consent signed by the legal representative (parent(s) or guardian(s))
* Obtaining the assent of adolescents able to understand the study (maturity and knowledge of HIV status)

Exclusion Criteria

* Infection with HIV-1 or HIV-1/HIV2 co-infection
Minimum Eligible Age

10 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Laquinitinie de Douala

UNKNOWN

Sponsor Role collaborator

Franceville International Center for Medical Research, Gabon

UNKNOWN

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Avelin F AGHOKENG, PhD

Role: STUDY_DIRECTOR

Institut de Recherche pour le Developpement

Ida C PENDA

Role: PRINCIPAL_INVESTIGATOR

Hôpital Laquinitie de Douala

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Laquinitie de Douala

Douala, , Cameroon

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Cameroon

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Avelin F AGHOKENG, PhD

Role: CONTACT

+(33)467415958

Ida C PENDA, PhD

Role: CONTACT

+(237)7770 31 55

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ida C Penda, PhD

Role: primary

+(237)7770 31 55

References

Explore related publications, articles, or registry entries linked to this study.

Djiyou ABD, Penda CI, Madec Y, Ngondi GD, Moukoko A, Varloteaux M, de Monteynard LA, Moins C, Moukoko CEE, Aghokeng AF. Viral load suppression in HIV-infected adolescents in cameroon: towards achieving the UNAIDS 95% viral suppression target. BMC Pediatr. 2023 Mar 15;23(1):119. doi: 10.1186/s12887-023-03943-0.

Reference Type DERIVED
PMID: 36922769 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ANRS 12406 EvvA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Neurocognitive Sub-study of Encore1
NCT01516060 COMPLETED PHASE3