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
Year: 2026
Type: article
Abstract: 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).
Source: Contemporary Clinical Trials
Authors: Diana Anena, Elizabeth Chappell, Rashidah Nazzinda, Cecilia Kiilu, Moses Chitsamatanga, Tiyara Arumugam, Alexandra Green, Cissy Kityo Mutuluuza, Mutsa Bwakura-Dangarembizi, Abraham Siika, Moherndran Archary, Lungile Jafta, Stella Namukwaya, Janet Seeley, George Akabwai, Henry Mugerwa, Lisanne Bevers, David Burger, Simon Walker, Alasdair Bamford, Annabelle South, Naomi Apoto, Molly Bush, Margaret J. Thomason, Ben Spittle, Deborah Ford, Adeodata R. Kekitiinwa, Sarah L. Pett, Clinton Otieno Achida, Dorcus Adhiambo, Gideon Ahimbisibwe, Maria Benita Aino, Helen Ainscough, George Patrick Akabwai, Diana Louis Anena, Juliet Ankunda, Naomi Apoto, Moherndran Archary, Tiyara Arumugam, 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, Molly Bush, 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, Charles 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 K. 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, Cecilia Kiilu, 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, 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, Alice Mudogo, Nathalie Mudzimirema, Shepherd Mudzingwa, Taona Mudzviti, Henry Mugerwa, Henry Mugerwa, 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, Stella Namukwaya, 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, Sarah Pett, George Pettitt, Ntombizonta Ignatia Phewa, Ampaire Phionah, Misheck Phiri, Sam Phiri, Mowlem Pierre, Sundrapragasen 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, Centurio Wandera, Edgar Ayesiga Wandigali, Scholastica Njeri Wanjiru, Sibusisiwe Weza, Ellen White, Eram David Williams
Institutions: Baylor College of Medicine Children’s Foundation, MRC Clinical Trials Unit at UCL, University College London, Medical Research Council, Joint Clinical Research Centre, Moi University, University of Zimbabwe, King Edward VIII Hospital, University of KwaZulu-Natal, PENTA Foundation, MRC/UVRI & LSHTM Uganda Research Unit, Uganda Virus Research Institute, London School of Hygiene & Tropical Medicine, Africa Health Research Institute, Radboud University Nijmegen, Radboud University Medical Center, University of York, Great Ormond Street Hospital for Children NHS Foundation Trust
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,140
Awards: BREATHER Plus: A randomised open-label 3-arm, 96-week trial evaluating the efficacy, safety and acceptability of weekends off dolutegravir-based antiretroviral therapy (ART) and monthly long-acting injectable ART compared to daily dolutegravir-based ART in virologically suppressed HIV-infected children and adolescents in sub-Saharan Africa, Respiratory infections, Blood borne viruses, G565924057
OpenAlex ID: W7119217202