The imperative for increased investment for an HIV cure
Remko van Leeuwen, Françoise Barré-Sinoussi, Michaela Müller-Trutwin, Asier Sáez-Cirión, Monique Nijhuis, Sharon R Lewin, Thumbi Ndung'u, Florence Riako-Anam, Mitchell Warren, Izukanji Sikazwe, Birgit Poniatowski, Beatriz Grinsztejn, Cissy Kityo, Masen Davis, Ole S Søgaard, Marcus Altfeld, Javier Martinez-Picado, Linos Vandekerckhove, Andrea Gramatica, Devin Sok, Simon Collins, Yazdan Yazdanpanah. The imperative for increased investment for an HIV cure. The Lancet HIV, volume 12, issue 10. October 2025. DOI: 10.1016/S2352-3018(25)00193-6
JCRC Publications
Cabotegravir and rilpivirine for treatment of HIV infection in Africa: week 96 results from the phase 3b randomized, open-label, noninferiority CARES trial
Cissy Kityo, Ivan K. Mambule, Joseph Musaazi, Simiso Sokhela, Henry Mugerwa, Ibrahim Yawe, Fiona Cresswell, Abraham Siika, Josphat Kosgei, Reena Shah, Logashvari Naidoo, Kimton Opiyo, Caroline Otike, Karlien Möller, Max Okwero, Charity Wambui, Veerle Van Eygen, Perry Mohammed, Fafa Addo Boateng, Nicholas I. Paton, on behalf of the CARES trial team. Cabotegravir and rilpivirine for treatment of HIV infection in Africa: week 96 results from the phase 3b randomized, open-label, noninferiority CARES trial. Nature Medicine. 04 November 2025. DOI: https://doi.org/10.1038/s41591-025-04041-7
The Association of Mild Kidney Disease with Coronary Artery Disease Is Stronger for People Living With HIV
Doshi Shradha, Richardson Barbra A., Nazzinda, Rashidah, Mugerwa Henry, Bittencourt Marcio Sommer, Erem Geoffrey, Narendrula Aparna, Farquhar Carey, Kityo Cissy, Longenecker Chris T. The Association of Mild Kidney Disease with Coronary Artery Disease Is Stronger for People Living With HIV. JAIDS Journal of Acquired Immune Deficiency Syndromes 101(1): p 95-102, January 1, 2026. DOI: 10.1097/QAI.0000000000003765 https://journals.lww.com/jaids/abstract/2026/01010/the_association_of_mild_kidney_disease_with.11.aspx
Trial design and enrolment characteristics of LATA (Long-Acting Treatment in Adolescents): a randomised, open-label, non-inferiority, 96-week trialevaluating the virological efficacy, safety, acceptability and quality-of-life of the dual long-acting injectable regimen (CAB/RPV) compared to daily oral therapy (DTG based TDF or TAF with 3TC or FTC backbone) in virologically suppressed adolescents living with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa
Anena Diana, Chappell Elizabeth, Nazzinda Rashidah, Kiilu Cecilia, Chitsamatanga Moses, Arumugam Tiyara, Green Alexandra, Green Alexandra, Kityo Cissy, Bwakura-Dangarembizi Mutsa F., Siika Abraham, M. Archary Moherndran, Jafta Lungile, Namukwaya Stella, Seeley Janet, Akabwai George Patrick, Mugerwa Henry, et al . 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 (CAB/RPV) compared to daily oral therapy (DTG based TDF or TAF with 3TC or FTC backbone) in virologically suppressed adolescents living with HIV-1 infection, aged 12 to <20 years, in Sub-Saharan Africa. Submitted 30 October 2025. Pre-print Available at SSRN: https://ssrn.com/abstract=5671058 or http://dx.doi.org/10.2139/ssrn.5671058
Weight Gain, Body Composition and Metabolic Parameters on Dolutegravir-Based Antiretroviral Therapy Versus Standard of Care in Children and Adolescents: A Secondary Analysis of the ODYSSEY Trial
Turkova Anna, White Ellen, Violari Avy, Mujuru Hilda, Kekitiinwa Adeodata R., Lugemwa Abbas, Kaudha Elizabeth, Na-Rajsima Sathaporn, Ahimbisibwe Grace Miriam, Variava Ebrahim, Archary Moherndran, Akhalwaya Yasmeen, Puthanakit Thanyawee, Bwakura-Dangarembizi Mutsa, Bbuye Dickson, Kasozi Mariam, Liberty Afaaf, Königs, Christoph Welch Steven, Riault Yoann, Bamford Alasdair, Cressey Tim R., Musoke Philippa, Kityo Cissy, Ferrand Rashida Abbas, Giaquinto Carlo et al. Weight Gain, Body Composition and Metabolic Parameters on Dolutegravir-Based Antiretroviral Therapy Versus Standard of Care in Children and Adolescents: A Secondary Analysis of the ODYSSEY Trial. Pre-print in The Lancet, Available at SSRN: https://ssrn.com/abstract=5413584 or http://dx.doi.org/10.2139/ssrn.5413584 https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5413584
BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily ART in virologically suppressed adolescents living with HIV aged 12 to <20 years in sub-Saharan Africa
Fredrick Katongole, Tiyara Arumugam, Angus Jennings, Constatine Mutata, Patrick Ssebunya, Charity Wamboi, Alexandra Green, Mutsa Bwakura-Dangarembizi, Cissy Kityo, Abraham Siika, et al, and the BREATHER Plus Trial Team. BREATHER Plus clinical trial design: A randomised non-inferiority trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily ART in virologically suppressed adolescents living with HIV aged 12 to <20 years in sub-Saharan Africa. Contemporary Clinical Trials. Epublished 29 May 2025. August 2025. DOI: 10.1016/j.cct.2025.107963
Short-cycle therapy (weekends-off) on dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a randomised, open-label, 96-week non-inferiority trial
Adeodata R. Kekitiinwa; Angus Jennings; Mutsa Bwakura Dangarembizi; Cissy Kityo; Abraham Siika; Alexandra Green; George Patrick Akabwai; Hilda Angela Mujuru; Henry Mugerwa; Cecilia Kiilu; Rosie Mngqibisa; Janet Seeley; Rashidah Nazzinda; Naomi Apoto; Resty Babirye Okello. Short-cycle therapy (weekends-off) on dolutegravir-based antiretroviral therapy in adolescents living with HIV (BREATHER Plus): a randomised, open-label, 96-week non-inferiority trial. The Lancet HIV, Published 29 October 2025.
Once-daily dolutegravir/lamivudine fixed-dose formulations in children living with HIV: a pharmacokinetic and safety sub-study nested in the open-label, multicentre, randomised, non-inferiority D3/PENTA 21 trial
Lisanne A.H Bevers, Gabriela Toledo, Muzamil Kisekka, Elizabeth Kaudha, Grace M. Ahimbisibwe, Isabella Depres, Tiyara Arumugam, Ebrahim Variava, Avy Violari, Iona White, Dickson Bbuye, Annet Nanduudu, Enoch Mulwanyi, Pauline Amuge, Diana A. Rutebarika, Adeodata R. Kekitiinwa, Cissy Kityo, et al, on behalf The D3 Trial Team. Once-daily dolutegravir/lamivudine fixed-dose formulations in children living with HIV: a pharmacokinetic and safety sub-study nested in the open-label, multicentre, Randomised, non-inferiority D3/PENTA21 trial. eBioMedicine, volume 120, The Lancet Discovery Science. September 03 2025. DOI: 10.1016/j.ebiom.2025.105929
Model-based evaluation of the interaction between ritonavirboosted atazanavir and rifampicin in Ugandan adults with HIV
Allan Kengo, Juan Eduardo, Resendiz-Galvan, Letisha Najjemba, Henry Mugerwa, Amedeo De Nicolo, et al. Model-based evaluation of the interaction between ritonavir-boosted atazanavir and rifampicin in Ugandan adults with HIV. British Journal of Clinical Pharmacology, 91(12):3471-3481. December 2025. DOI: 10.1002/bcp.70195
Expanding access to long-acting HIV therapy in low-income and middle-income countries
Cissy Kityo, Fiona V. Cresswell, C. Orkin, M. Piccolis, L. Gaayeb, F. Venter. Closing the Gap: Expanding Access to Long-Acting HIV Therapy in low- and middle-income countries (LMICs). The Lancet Global Health, volume 13, issue 9: E1502-E1503. September 2025. DOI 10.1016/S2214-109X(25)00280-3
Potential impact and cost-effectiveness of long-acting injectable lenacapavir plus cabotegravir as HIV treatment in Africa
Andrew Phillips, Jennifer Smith, Loveleen Bansi-Matharu, Kenly Sikwese, Cissy Kityo, Charles Flexner, Marco Vitoria, et al. Potential impact and cost-effectiveness of long-acting injectable lenacapavir plus cabotegravir as HIV treatment in Africa. Nature Communications,16:5760. July 01 2025. DOI https://doi.org/10.1038/s41467-025-60752-y
Virological and drug-resistance outcomes for people living with HIV initiating or switching to tenofovir, lamivudine, and dolutegravir in six PEPFAR-supported countries: a prospective cohort study
Jean Bernard Marc, Caitlyn McCarthy, Carole L. Wallis, Cissy Kityo, Gary Maartens, Francis Kanyike, Marije Van Schalkwyk, Raymond Bernard Kihumuro, Philip Asiimwe, Isaac Tsikhutsu, Cornelius Munyanga, Yukari C. Manabe, ACTG A5381/Hakim Study Team. Virologic and Resistance Outcomes for Persons Living with HIV who Initiated or Switched to Tenofovir-Lamivudine-Dolutegravir in PEPFAR Countries: An Observational Study. The Lancet HIV, volume 12, issue 12. December 2025. DOI https://doi.org/10.1016/S2352-3018(25)00162-6
Pharmacokinetics, Safety and Antiviral Activity of Rilpivirine in Antiretroviral-naïve Children With HIV ≥6 to <12 Years Old
Lombaard Johan, Foulkes Sharne, Natukunda Eva, Kurosawa Ken, Shibuya Minaka, Vanveggel Simon, Van Landuyt Erika, Ssali Francis. Pharmacokinetics, Safety and Antiviral Activity of Rilpivirine in Antiretroviral-naïve Children with HIV ≥6 to <12 Years Old: Week 48 and Final Analysis of Cohort 2 From the Open-label, Phase 2 PAINT Study. The Pediatric Infectious Disease Journal. April 18 2025 https://doi.org/10.1097/inf.0000000000004828
Virology Outcomes of Tenofovir-lamivudine-dolutegravir in Treatment-naïve and Virologically Suppressed Individuals Switching From an NNRTI-based Regimen: An Observational Analysis at 13 Sites
Cissy Kityo, Caitlyn McCarthy, Serena P Koenig, Michael D Hughes, Carole L Wallis, Cornelius Munyanga, Noluthando Mwelase, Sarita Shah, Yuka C Manabe, Catherine Godfrey, Elizabeth Woolley, Charles Flexner, and the ACTG A5381/Hakim Study Team. Virology Outcomes of Tenofovir-Lamivudine-Dolutegravir in Treatment-Naïve and Virologically Suppressed Individuals Switching from an NNRTI-Based Regimen: An Observational Analysis at 13 Sites. Open Forum Infectious Diseases. May 02 2025 https://doi.org/10.1093/ofid/ofaf270
High prevalence of low-level viremia among infants initiated on antiretroviral drugs following mother-to-child transmission of HIV
Immaculate Nankya1, Eva Natukunda, Diana Rutebarika, Christine Matama, Roy Basiimwa, Paul Arikod, Faryad Muwabe1, Caroline Otike, and Cissy Kityo. High prevalence of low-level viremia among infants initiated on antiretroviral drugs following mother-to-child transmission of HIV. AIDS Research and Therapy, volume 2, Article 34. 11 March 2025. DOI: 10.1186/s12981-025-00701-3
Second-Line Antiretroviral Therapy for Children Living with HIV in Africa
Victor Musiime, Mutsa Bwakura-Dangarembizi, Alexander J. Szubert, Vivian Mumbiro, Hilda A. Mujuru, Cissy M. Kityo, Abbas Lugemwa, Katja Doerholt, Chishala Chabala, Shafic Makumbi, Veronica Mulenga, Helen McIlleron, David Burger, Eva Natukunda, Clare Shakeshaft, Kyomuhendo Jovia Linda, Kusum Nathoo, Lara Monkiewicz, Ibrahim Yawe, et al, for the CHAPAS-4 Trial Team: Second-line antiretroviral therapy for children living with HIV in Africa. New England Journal of Medicine, 392:1917-32. 3rd March 2025. DOI: https://www.nejm.org/doi/full/10.1056/NEJMoa2404597
Efficacy and safety of B/F/TAF in treatmentnaïve and virologically suppressed people with HIV≥50 years of age: integrated analysis from six phase 3 clinical trials
Cissy M. Kityo, Samir K. Gupta, Princy N. Kumar, Amy R. Weinberg, Bhumi Gandhi-Patel, Hui Liu, Jason T. Hindman, Jürgen K. Rockstroh. Efficacy and Safety of B/F/TAF in Treatment-naïve and Virologically Suppressed People With HIV ≥50 Years of Age: Integrated Analysis From Six Phase 3 Clinical Trials. BMC Infectious Diseases, volume 25, Article 1061. 04 March 2025. DOI: https://doi.org/10.1186/s12879-025-11476-3
Objectively Measured Physical Activity among People with and without HIV in Uganda: Associations with Cardiovascular Risk and Coronary Artery Disease
Opara CC, Horvat Davey C, Kityo C, Brinza E, Nazzinda R, Bittencourt MS, Oliveira V, Webel AR, Chris T. Longenecker. Objectively Measured Physical Activity among People with and without HIV in Uganda: Associations with Cardiovascular Risk and Coronary Artery Disease. Global Heart. Global Heart. 10 Feb 2025 DOI: https://doi.org/10.5334/gh.1398
Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People With HIV From 6 Countries
N Sarita Shah, Cissy Kityo, Mulinda Nyirenda, Mohammed Rassool, Rodney Dawson, Yvetot Joseph, Fatma Some, Yukari C Manabe, John W Mellors, Charles Flexner, Gary Maartens, ACTG A5381/Hakim Study Team. Effectiveness of Double-Dose Dolutegravir in People Receiving Rifampin-based Tuberculosis Treatment: An Observational, Cohort Study of People with HIV From 6 Countries. Clinical Infectious Diseases, May 13 2024, Volume 80, Issue 1, 15 Jan 2025 https://doi.org/10.1093/cid/ciae269
Virological outcomes and genotypic resistance on dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial
Ellen White, Cissy Kityo, Moira J Spyer, Hilda A Mujuru, Immaculate Nankya, Adeodata R Kekitiinwa, Abbas Lugemwa, Elizabeth Kaudha, Afaaf Liberty, Haseena Cassim, Moherndran Archary, Mark F Cotton, Grace Miriam Ahimbisibwe, Deborah Ford, Anna Turkova, ODYSSEY Trial Team. Virological outcomes and genotypic resistance in children and adolescents randomised to dolutegravir-based ART vs. standard-of-care: a secondary analysis of the ODYSSEY trial. The Lancet HIV, volume 12, Issue 3, E201-E213. March 2025 https://doi.org/10.1016/s2352-3018(24)00155-3
Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) study
Nigel Garrett, Asa Tapley, Aaron Hudson, Sufia Dadabhai, …. Cissy Kityo Mutuluuza, Nivashnee Naicker, Vimla Naicker, Gray, Yunda Huang, and Philip Kotze. Hybrid versus vaccine immunity of mRNA-1273 among people living with HIV in East and Southern Africa: a prospective cohort analysis from the multicentre CoVPN 3008 (Ubuntu) study. eClinicalMedicine volume 80, 103054, The Lancet Discovery Science. Feb 2025 https://doi.org/10.1016/j.eclinm.2024.103054
Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: a double-blind, randomised, placebo-controlled trial
Anne E P Frosch, Victor Musiime, Christopher Staley, Andrea L Conroy, Diana Rutebarika, Gilbert Ategeka, Sarah E Cusick. Safety and efficacy of iron supplementation with 3 months of daily ferrous sulphate in children living with HIV and mild-to-moderate anaemia in Uganda: A double-blind, randomised, placebo-controlled trial. The Lancet HIV. https://doi.org/10.1016/S2352-3018(24)00238-8 Published: 11 Oct 2024
Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomised, multicentre, open-label, non-inferiority trial
non-inferiority trial. The Lancet Infectious Diseases. 2024 Oct 1;24(10):1083-92. DOI:https://doi.org/10.1016/S1473-3099(24)00289-5
Changes in the Lipidome Are Associated With Immune Activation and Subclinical Vascular Disease in Youth With Human Immunodeficiency Virus in Uganda
Sahera Dirajlal-Fargo, Melica Nikahd, Kate Ailstock, Manjunath Manubolu, Victor Musiime, Cissy Kityo, Grace A McComsey, Nicholas T. Funderburg. Changes in the lipidome are associated with immune activation and subclinical vascular disease in youth with HIV in Uganda. The Journal of Infectious Diseases, jiae461, https://doi.org/10.1093/infdis/jiae461 Published: 27 Sep 2024
Consensus-driven target product profiles for curative sickle cell disease gene therapies
Bukini D, Makani J, McCune J, Lee D, Bansbach C, De Vita S, Kemps D, Amin E, Spector J, Tisdale J. Consensus-driven target product profiles for curative sickle cell disease gene therapies. Molecular Therapy Methods & Clinical Development. 2024 Sep 12;32(3). DOI: 10.1016/j.omtm.2024.101287
Facilitators and barriers to initiating and completing tuberculosis preventive treatment among children and adolescents living with HIV in Uganda: a qualitative study of adolescents, caretakers and health workers
Pauline Mary Amuge, Denis Ndekezi, Moses Mugerwa, Dickson Bbuye, Diana Antonia Rutebarika, Lubega Kizza, Christine Namugwanya, Angella Baita, Peter James Elyanu, Patricia Nahirya Ntege, Dithan Kiragga, Carol Birungi, Adeodata Rukyalekere Kekitiinwa, Agnes Kiragga, Moorine Peninah Sekadde, Nicole-Austin Salazar, Anna Maria Mandalakas & Philippa Musoke. Facilitators and barriers to initiating and completing tuberculosis preventive treatment among children and adolescents living with HIV in Uganda: A qualitative study of adolescents, caretakers and health workers. AIDS research and therapy. 2024 Aug 29;21(1):59. https://doi.org/10.1186/s12981-024-00643-2
A miniaturized wash-free microfluidic assay for electrical impedance-based assessment of red blood cell-mediated microvascular occlusion
Oshabaheebwa S, Delianides CA, Patwardhan AA, Evans EN, Sekyonda Z, Bode A, Apio Faith M, Mutuluuza CK, Sheehan VA, Suster MA, Gurkan UA. A miniaturized wash-free microfluidic assay for electrical impedance-based assessment of red blood cell-mediated microvascular occlusion. Biosensors and Bioelectronics. 2024 Aug 15;258:116352. DOI: 10.1016/j.bios.2024.116352
…So that’s why we hide, we don’t want them to know’— challenges to antiretroviral therapy adherence in Kampala, Uganda
Bruser G, Luginaah I, Katasi R, Zhang LZ, Namasinga Miriam, Kityo Cissy, Arts Eric. "…So that's why we hide, we don't want them to know"- Challenges to Antiretroviral Therapy Adherence in Kampala, Uganda. African Geographical Review. 2024;43(1):18-31. doi: 10.1080/19376812.2022.2101496. Epub 2022 Jul 18. PMID: 38576439; PMCID: PMC10989837. DOI: 10.1080/19376812.2022.2101496
D3/Penta 21 clinical trial design: A randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years
Turkova A, Chan MK, Kityo Cissy, Kekitiinwa AR, Musoke P, Violari A, Variava E, Archary M, Cressey TR, Chalermpantmetagul S, Sawasdichai K, … D3 Trial Team. D3/Penta 21 clinical trial design: a randomised non-inferiority trial with nested drug licensing substudy to assess dolutegravir and lamivudine fixed dose formulations for the maintenance of virological suppression in children with HIV-1 infection, aged 2 to 15 years. Contemporary Clinical Trials. 2024 Jul 1;142:107540. DOI: 10.1016/j.cct.2024.107540
Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study
Jensen TO, Murray TA, Grandits GA, Jain MK, Grund B, Shaw-Saliba K, Matthay MA, Abassi M, Ardelt M, Baker JV, Chen P, Dewar RL, Goodman AL, Hatlen TJ, Highbarger HC, Holodniy M, Lallemand P, Laverdure S, Leshnower BG, Looney D, Moschopoulos CD, Mugerwa Henry, Murray DD, Mylonakis E, Nagy-Agren S, Rehman MT, Rupert A, Stevens R, Turville S, Weintrob A, Wick K, Lundgren J, Ko ER; ACTIV-3/TICO Study Group. Early trajectories of virological and immunological biomarkers and clinical outcomes in patients admitted to hospital for COVID-19: an international, prospective cohort study. Lancet Microbe. 2024 Jun;5(6):e559-e569. doi:10.1016/S2666-5247(24)00015-6. Epub 2024 May 27. PMID: 38815595; PMCID: PMC11181148. DOI: 10.1016/S2666-5247(24)00015-6
