ANRS 12406 EvvA Study

HIV-1-infection Clinical Trial

— EvvA  

Official title:

Virological Failure and HIV Drug Resistance Among Adolescents Receiving Antiretroviral Treatment in Cameroon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593979
• Other study ID #: ANRS 12406 EvvA
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: January 14, 2022

Study information

• Verified date: April 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: Avelin F AGHOKENG, PhD
• Phone: +(33)467415958
• Email: avelin.aghokeng[@]ird.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 289
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV-1-infection

Locations

Country	Name	City	State
Cameroon	Hôpital Laquinitie de Douala	Douala

Sponsors (4)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Franceville International Center for Medical Research, Gabon, Hospital Laquinitinie de Douala, Institut Pasteur

Country where clinical trial is conducted

Cameroon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load suppression after = 6 months of antiretroviral therapy	Proportion of participants with HIV-1 RNA <1000 copies / ml after = 6 months of antiretroviral therapy	Day 0
Secondary	Drug resistance after = 6 months of antiretroviral therapy	Proportion of participants with HIV-1 RNA = 300 copies / ml and presence of antiretroviral-resistant virus (ARV) after = 6 months of antiretroviral therapy	3 months