Accès ouvert déclaré
2026
article
Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa
Diana Anena, Elizabeth Chappell, Rashidah Nazzinda, Cecilia Kiilu, Moses Chitsamatanga, Tiyara Arumugam, Alexandra Green, Cissy Kityo Mutuluuza, Bwakura-Dangarembizi Mutsa, Abraham Siika, Moherndran Archary, Lungile Jafta, Stella Namukwaya, Janet Seeley, George Patrick Akabwai, Henry Mugerwa, Lisanne A. H. Bevers, David Burger, Simon Walker, Alasdair Bamford, Annabelle South, Naomi Apoto, Molly Bush, Margaret J. Thomason, Ben Spittle, Deborah Ford, Adeodata Kekitiinwa, Sarah Pett, Clinton Otieno Achida, Dorcus Adhiambo, Gideon Ahimbisibwe, M. Aino, Helen Ainscough, Diana Louis Anena, Juliet Ankunda, Moherndran Archary, Allen Asiimwe, Juliet Ategeka, Abigail Atwine, Edward Bagirigomwa, Angella Baita, Henry Balwa, Alasdair Bamford, Simangele Abigail Bengu, Sarah Bernays, Lisanne Bevers, Joyline Bhiri, Raziya Bobat, Mwanje John Bosco, Ruth Bosire, David Burger, Karina Butler, Mutsawashe Bwakura-Dangarembizi, Precious Sphiwe Cebekhulu, Vongai Margaret Chanaiwa, Elizabeth Chappell, Mary Chebet, Cornelius Chege, Rispher Chepkoech, Benedister Kangogo Cheruiyot, Salinah Cherutich, Lynette Chibanda, Tinashe Chidemo, Ennie Chidziva, Joy Chimanzi, Shingirai Chimene, Stuart Chitongo, Moses Chitsamatanga, Rufaro Chivaura, Julie Chepchumba Choge, Kelly Shermon Clark, Angela Colbers, Magda Conway, Paul Crawley, Jane Crawley, Baliruno David, Odoch Denis, Nicholas Dhibi, Rebecca Dodds, C Draleku, Prosper Sibonile Dube, Brenda Namukwaya Efrance, Wilson Lokitala Ekiru, Deborah Ford, Nathan Ford, Shauna Francis, Carlo Giaquinto, Diana Gibb, Shauri Kahindi Gona, Secrecy Gondo, Alexandra Green, Shamiso Barbara Gwande, Tsitsi Gwenzi, Margaret Hook, Tom Jacobs, Lungile Jafta, Beatrice Jakait, Angus Jennings, Eslyne Jepkemboi, Eunice Jepkemboi, Edna Jepngetich, Roselyn Kabasingo, Rose Jacqueline Kadhuba, Deborah Kahinju, Hebron Kalikwani, Benedister Kangogo, Crispus Katemba, Alfed Kateta, Fredrick Katongole, Elizabeth Kaudha, Jovia Kavuma, Hilda Kaziga, Rodney Kazooba, Adeodata Kekitiinwa, Addy Kekitiinwa, Teddy Kembabazi, Mthokozisi Khuzwayo, Nicholas Kigen, Rachael Namuddu Kikabi, Vincent Kipchirchir, Hellen Jerotich Kiplagat, Damaris Jepchumba Kiprutto, Getruth Jerop Kiptoo, Jairus Kipyego, Anthony Kirabira, Jessica Kirk, Viola Kirui, Richard Kipsang Kirui, Jeremy Kirunda, Muzamil Nsibuka Kisekka, Cissy Kityo, Lameck Kiyimba, Josephine Kobusingye, Violet Korutaro, Joan Chepkurui Kotut, Vinie Kouamou, Priscilla Kyobutungi, Ocitti Sunday Paul Labeja, Faith Balmoi Labote, Damaris Lagat, Cleopatra Langa, Victor Kibet Langat, Lekku Lawrence, Timothy Lubwama, Muhammad Lutalo, Ezra Lutalo, Christopher Lwanga, Cornelius Magut, Imelda Mahaka, Caroline Watiri Maina, Nathaniel Malatjie, Bernadette Malunda, Wendy Mapfumo, Edson Marimo, Lydiah Maru, Peace Hellen Masiga, Fathima Mather, Farai Selina Matimba, Allen Matubu, Ritah Mbabazi, Frank Mbamanya, Faith Mbasani, Cecilia Chebet Mengich, Xeshelihle Mhlanga, Jabu Mkhulise, Innocentia Thandokuhle Mncube, Rosie Mngqibisa, Zethu Mnyandu, Martha Mokeira Mokaya, Michelle Moodley, Nozibusiso Rejoice Mosia, Columbus Moyo, A Mudogo, Nathalie Mudzimirema, Shepherd Mudzingwa, Taona Mudzviti, Hilda Mujuru, Collins Mujyanama, Trust Mukanganiki, Barbara Mukanza, Dorinda Mukura, Disan Mulima, Vivian Mumbiro, Ida Mundhree, Hazel Patricia Munyama, Dorothy Murungu, Sandra Musarurwa, Victor Musiime, Alex V. Musiime, Godfrey Musoro, Sharif Musumba, Philemon Kipchirchir Mutai, Constantine Mutata, Khombisile Muthwa, Shirley Mutsai, Matthew Justus Mutuku, Nabuuma Haawa Muweesi, Gerald Agaba Muzorah, Elaine Mwandiwata, Martha Kaimuri Mwongela, Mariam Naabalamba, Ronald Nabimba, Shirat Nakabiri, Shamim Nakabuye, Bibian Nakigozi Nakato, Dridah Nakiboneka, Priscilla Nakiwala, Cate Naluyima, Rose Namaganda, Miriam Namasinga, Christine Nambi, Anna Ritah Namuganga, Florence Namuli, Josephine Namusanje, Jamilah Namwanga, Joan Nangiya, Mary Nannungi, Mangadalen Nansaigi, Jesca Nantale, Joan Nantege, Barbra Nantume, Claire Nasaazi, Kusum Nathoo, Rashidah Nazzinda, Milly Ndigendawani, Makhosonke Ndlovu, Tshamand Fulufhelo Netshitangani, Solomon Kimurgor Ngetich, Hanh Nguyen, Pia Ngwaru, Nothando Ngwenya, Ruth Nhema, Michael Njenga, Florence Kiwunja Njulu, Nombuso Nkosi, Aoife Nolan, Patricia Nahirya Ntege, Rashina Nundlal, Lynnet Nyakudya, Winstone Nyandiko, Sylvia Nylobo, Gideon Obila, Brian Odul, Resty Babirye Okello, Vincent Otieno Onyango, Dorcas Akinyi Opot, Millicent Orido, Tom Oyoo Osoro, Carol Otike, Benson Ouma, Evans Ochieng Ouno, Kennedy Oyamo, Sara Peres, Sarah Pett, George Pettitt, Ntombizonta Ignatia Phewa, Ampaire Phionah, Misheck Phiri, Sam Phiri, M. Pierre, Sada Pillay, Clement Pillay, Anton Pozniak, Rayania Premoutt, Paul Revill, Saajida Rizvi, Eddie Rubanga, Baker Rubinga, Festus Kirwa Rugut, Diana Antonia Rutebarika, Simona Salomone, Violah Samoei, Iris Jaluha Sande, Natalie Sang, Janet Seeley, Tamlyn Seunanden, Popi Shabalala, Amina Msuo Shali, Mercy Shibemba, Jemima Shickle, Abraham Siika, Sophia Simatwa, Sheleika Singh, Sidney Sithole, Annabelle South, Patrick Ssebunya, Andy Sum, Hannah Sweeney, Teri Tarus, Rodolphe Thiebaut, Margaret Thomason, Judith Tikabibamu, Musunga Tomu, Ronald Tonui, Stephen Townsend, Maureen Tshuma, Susan Tukamuhebwa, Nadine Van Looy, Deka Vincent, Avy Violari, Simon Walker, Charity Wambui, Cynthia Wandera, Edgar Ayesiga Wandigali, Scholastica Njeri Wanjiru, Sibusisiwe Weza, Ellen White, Eram David Williams
1Citations signalées — pas une note de qualité
16Institutions déclarées
7Pays d’affiliation déclarés
Résumé fourni par la source
BACKGROUND: Alternatives to daily oral antiretroviral therapy (ART) are important for adolescents with HIV (AHIV) to improve adherence and outcomes. Long-Acting-injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) has demonstrated excellent efficacy and safety and strong patient preference in adults. METHODS: LATA is an ongoing randomised, open-label, 96-week, non-inferiority trial evaluating the efficacy, safety and acceptability of LAI CAB/RPV vs. daily oral therapy with tenofovir (disoproxil fumarate or alafenamide)/lamivudine/dolutegravir (TLD). Participants are virologically suppressed AHIV aged 12- < 20 years in Kenya/South Africa/Uganda/Zimbabwe. Randomisation was 1:1 to LAI CAB/RPV given once every 8 weeks (after optional oral lead-in) or daily oral TLD. The primary outcome is viral rebound (two consecutive viral loads ≥50 copies/mL by 96-weeks). Viral loads are measured every 24 weeks. The trial employs the Smooth Away From the Expected (SAFE) non-inferiority frontier, where the non-inferiority margin depends on the observed event rate in the control arm. Secondary outcomes include confirmed viral load ≥200 copies/mL by 96-weeks, HIV resistance, safety, patient-reported outcomes and cost-effectiveness. LAI participants return to oral ART at confirmed viral load ≥200 copies/mL; LAI participants who become pregnant are given the choice to continue on LAI or to switch back to daily oral ART, with optional pharmacokinetic sampling during pregnancy and post-partum in both groups. Enrolment of 476 AHIV completed in April 2024. Results will be reported in 2026. CONCLUSION: LATA is the first trial comparing the efficacy, safety and acceptability of LAI CAB/RPV to oral ART in AHIV, enrolled in Sub-Saharan Africa, using a programmatic approach to viral load testing. TRIAL REGISTRATION: This trial has been registered with ClinicalTrials.gov (NCT05154747).
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Contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): A randomised, open-label, non-inferiority, 96-week trial evaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen cabotegravir/ rilpivirine compared to daily oral therapy in virologically suppressed adolescents with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa
- Date Crossref
- 01/03/2026
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude et ne compte pas comme une seconde source scientifique indépendante.
Institutions déclarées
Une affiliation ne permet pas de déduire la nationalité d’un auteur.
Sujets associés
HIV/AIDS drug development and treatmentHIV-related health complications and treatmentsHIV/AIDS Research and Interventions