ANRS 12406 EvvA Study

• Conditions: HIV-1-infection

• Registration Number: NCT04593979
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2021-04
• Study Start: 2021-04-15
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 289

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)

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Exclusion Criteria

• Infection with HIV-1 or HIV-1/HIV2 co-infection

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Viral load suppression after ≥ 6 months of antiretroviral therapy	Day 0	Proportion of participants with HIV-1 RNA \<1000 copies / ml after ≥ 6 months of antiretroviral therapy

Secondary Outcome Measures

Name	Time	Method
Drug resistance after ≥ 6 months of antiretroviral therapy	3 months	Proportion of participants with HIV-1 RNA ≥ 300 copies / ml and presence of antiretroviral-resistant virus (ARV) after ≥ 6 months of antiretroviral therapy

Trial Locations

Locations (1)

Hôpital Laquinitie de Douala; 🇨🇲 Douala, Cameroon