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Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study

BACKGROUND: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immu...

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Autores principales: Nielsen-Saines, Karin, Mitchell, Kate, Kerin, Tara, Fournier, Jasmine, Kozina, Leslie, Andrews, Brenda, Cortado, Ruth, Bolan, Robert, Flynn, Risa, Rotheram, Mary Jane, Abdalian, Sue Ellen, Bryson, Yvonne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351983/
https://www.ncbi.nlm.nih.gov/pubmed/30650057
http://dx.doi.org/10.2196/10807
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author Nielsen-Saines, Karin
Mitchell, Kate
Kerin, Tara
Fournier, Jasmine
Kozina, Leslie
Andrews, Brenda
Cortado, Ruth
Bolan, Robert
Flynn, Risa
Rotheram, Mary Jane
Abdalian, Sue Ellen
Bryson, Yvonne
author_facet Nielsen-Saines, Karin
Mitchell, Kate
Kerin, Tara
Fournier, Jasmine
Kozina, Leslie
Andrews, Brenda
Cortado, Ruth
Bolan, Robert
Flynn, Risa
Rotheram, Mary Jane
Abdalian, Sue Ellen
Bryson, Yvonne
author_sort Nielsen-Saines, Karin
collection PubMed
description BACKGROUND: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies because of challenges in identification and adherence to cART. OBJECTIVE: This study aimed to identify and promptly treat with cART youth aged 12 to 24 years in Los Angeles and New Orleans who have acute, recent, or established HIV infection, as determined by Fiebig stages 1 to 6 determined by viral RNA polymerase chain reaction, p24 antigen presence, and HIV-1 antigen Western blot. The protocol recommends treatment on the day of diagnosis when feasible. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to antiretroviral therapy (ART) are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time, and correlate these data with the duration of viral suppression. METHODS: A total of 72 youth (36 acutely infected and 36 treatment naïve controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to the standard of care HIV-1 management guidelines and followed for a period of 2 years. Assessments are conducted at specific time points throughout these 2 years of follow-up for monitoring of adherence to ART, viral load, magnitude of HIV reservoirs, and presence of coinfections. RESULTS: The study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of September 30, 2018, a total of 37 youth were enrolled, 12 with recently acquired, 16 with established HIV infection as determined by Fiebig staging, and 9 pending determination of Fiebig status. Recruitment and enrollment are ongoing. CONCLUSIONS: We hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, that is, those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/10807
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spelling pubmed-63519832019-02-22 Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study Nielsen-Saines, Karin Mitchell, Kate Kerin, Tara Fournier, Jasmine Kozina, Leslie Andrews, Brenda Cortado, Ruth Bolan, Robert Flynn, Risa Rotheram, Mary Jane Abdalian, Sue Ellen Bryson, Yvonne JMIR Res Protoc Protocol BACKGROUND: Early treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies because of challenges in identification and adherence to cART. OBJECTIVE: This study aimed to identify and promptly treat with cART youth aged 12 to 24 years in Los Angeles and New Orleans who have acute, recent, or established HIV infection, as determined by Fiebig stages 1 to 6 determined by viral RNA polymerase chain reaction, p24 antigen presence, and HIV-1 antigen Western blot. The protocol recommends treatment on the day of diagnosis when feasible. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to antiretroviral therapy (ART) are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time, and correlate these data with the duration of viral suppression. METHODS: A total of 72 youth (36 acutely infected and 36 treatment naïve controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to the standard of care HIV-1 management guidelines and followed for a period of 2 years. Assessments are conducted at specific time points throughout these 2 years of follow-up for monitoring of adherence to ART, viral load, magnitude of HIV reservoirs, and presence of coinfections. RESULTS: The study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of September 30, 2018, a total of 37 youth were enrolled, 12 with recently acquired, 16 with established HIV infection as determined by Fiebig staging, and 9 pending determination of Fiebig status. Recruitment and enrollment are ongoing. CONCLUSIONS: We hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, that is, those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/10807 JMIR Publications 2019-01-16 /pmc/articles/PMC6351983/ /pubmed/30650057 http://dx.doi.org/10.2196/10807 Text en ©Karin Nielsen-Saines, Kate Mitchell, Tara Kerin, Jasmine Fournier, Leslie Kozina, Brenda Andrews, Ruth Cortado, Robert Bolan, Risa Flynn, Mary Jane Rotheram, Sue Ellen Abdalian, Yvonne Bryson, Adolescent Medicine Trials Network (ATN) CARES Team. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.01.2019. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Nielsen-Saines, Karin
Mitchell, Kate
Kerin, Tara
Fournier, Jasmine
Kozina, Leslie
Andrews, Brenda
Cortado, Ruth
Bolan, Robert
Flynn, Risa
Rotheram, Mary Jane
Abdalian, Sue Ellen
Bryson, Yvonne
Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study
title Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study
title_full Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study
title_fullStr Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study
title_full_unstemmed Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study
title_short Acute HIV Infection in Youth: Protocol for the Adolescent Trials Network 147 (ATN147) Comprehensive Adolescent Research and Engagement Studies (CARES) Study
title_sort acute hiv infection in youth: protocol for the adolescent trials network 147 (atn147) comprehensive adolescent research and engagement studies (cares) study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6351983/
https://www.ncbi.nlm.nih.gov/pubmed/30650057
http://dx.doi.org/10.2196/10807
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