HIV-1-infectionEvvANCT04593979
ANRS 12406 EvvA Study
An observational study of HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 1 site in Cameroon.
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. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- HIV-1-infection
- How many people
- 289 participants
- Where
- 1 siteCameroon
- Study dates
- 15 Apr 2021to 14 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study will include adolescents living with HIV infection, aged 10 to 19 years and follow-up in a treatment unit in Douala, Cameroon.
Who may be able to join
- 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)
Who cannot join
- Infection with HIV-1 or HIV-1/HIV2 co-infection
Trial locations and contacts
1 site in 1 country.
Cameroon1 site, 1 recruiting
- Recruiting
Hôpital Laquinitie de Douala
Douala
Ida C Penda, PhD, +(237)7770 31 55, calix.penda@gmail.com
About this study
Official title: Virological Failure and HIV Drug Resistance Among Adolescents Receiving Antiretroviral Treatment in Cameroon
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
Read the 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
- Conditions
- HIV-1-infection
- Keywords
- Virological failure, HIV drug resistance, Adolescents, Cameroon
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start15 Apr 2021
- Primary completion14 Jan 2022 (estimated)
- Study completion14 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Hospital Laquinitinie de Douala, Franceville International Center for Medical Research, Gabon, Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- Avelin F AGHOKENG, PhD, Study director, Institut de Recherche pour le DeveloppementIda C PENDA, Principal investigator, Hôpital Laquinitie de Douala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593979
- Sponsor's protocol ID
- ANRS 12406 EvvA
- Acronym
- EvvA
- Status last verified
- Apr 2021
- First submitted
- 5 Oct 2020
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided later
Publications
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.
PubMed 36922769
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virological Failure and HIV Drug Resistance Among Adolescents Receiving Antiretroviral Treatment in Cameroon
- ClinicalTrials.gov ID
- NCT04593979
- Acronym / sponsor ID
- EvvA / ANRS 12406 EvvA
- Conditions
- HIV-1-infection
- Keywords
- Virological failure, HIV drug resistance, Adolescents, Cameroon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Hospital Laquinitinie de Douala, Franceville International Center for Medical Research, Gabon, Institut Pasteur
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 14 Jan 2022 (estimated)
- Study completion
- 14 Jan 2022 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study will include adolescents living with HIV infection, aged 10 to 19 years and follow-up in a treatment unit in Douala, Cameroon.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- Infection with HIV-1 or HIV-1/HIV2 co-infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Viral load suppression after ≥ 6 months of antiretroviral therapy
Time frame: Day 0
Proportion of participants with HIV-1 RNA <1000 copies / ml after ≥ 6 months of antiretroviral therapy
1 secondary outcome
Drug resistance after ≥ 6 months of antiretroviral therapy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Derived from this study: PubMed 36922769Djiyou 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.
- Individual participant dataSharing planned: Undecided. To be decided later
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avelin F AGHOKENG, PhD study director
Institut de Recherche pour le Developpement
Ida C PENDA principal investigator
Hôpital Laquinitie de Douala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by ANRS, Emerging Infectious Diseases at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avelin F AGHOKENG, PhD (+(33)467415958, avelin.aghokeng@ird.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral load suppression after ≥ 6 months of antiretroviral therapy (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.