drugset / Trial / NCT03707977
Dual bNAb Treatment in Children
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies, VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in Botswana.
Timeline
- Start
- 2019-06-17
- Primary completion
- 2021-12-03
- Completion
- 2021-12-03
Publications
- Results Capparelli EV, Ajibola G, Maswabi K, Holme MP, Bennett K, Powis KM, Moyo S, Mohammed T, Maphorisa C, Hughes MD, Seaton KE, Tomaras GD, Mosher S, Taylor A, O'Connell S, Narpala S, Mcdermott A, Caskey M, Gama L, Lockman S, Jean-Philippe P, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL; Tatelo Study Team. Safety and Pharmacokinetics of Intravenous 10-1074 and VRC01LS in Young Children. J Acquir Immune Defic Syndr. 2022 Oct 1;91(2):182-188. doi: 10.1097/QAI.0000000000003033.
- Results Shapiro RL, Ajibola G, Maswabi K, Hughes M, Nelson BS, Niesar A, Pretorius Holme M, Powis KM, Sakoi M, Batlang O, Moyo S, Mohammed T, Maphorisa C, Bennett K, Hu Z, Giguel F, Reeves JD, Reeves MA, Gao C, Yu X, Ackerman ME, McDermott A, Cooper M, Caskey M, Gama L, Jean-Philippe P, Yin DE, Capparelli EV, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M. Broadly neutralizing antibody treatment maintained HIV suppression in children with favorable reservoir characteristics in Botswana. Sci Transl Med. 2023 Jul 5;15(703):eadh0004. doi: 10.1126/scitranslmed.adh0004. Epub 2023 Jul 5.
- Results Banga J, Nelson BS, Ajibola G, Mohammed T, Maphorisa C, Boleo C, Moyo S, Batlang O, Sakoi-Mosetlhi M, Maswabi K, Holme MP, Powis KM, Lockman S, Hughes MD, Makhema J, Kuritzkes DR, Litcherfeld M, Shapiro R. Predictive markers for sustained viral suppression on dual bNAbs during ART interruption in children. J Acquir Immune Defic Syndr. 2025 Mar 26:10.1097/QAI.0000000000003663. doi: 10.1097/QAI.0000000000003663. Online ahead of print.
- Results Sakoi-Mosetlhi M, Ajibola G, Haghighat R, Batlang O, Maswabi K, Pretorius-Holme M, Powis KM, Lockman S, Makhema J, Litcherfeld M, Kuritzkes DR, Shapiro R. Caregivers of children with HIV in Botswana prefer monthly IV Broadly Neutralizing Antibodies (bNAbs) to daily oral ART. PLoS One. 2024 Mar 27;19(3):e0299942. doi: 10.1371/journal.pone.0299942. eCollection 2024.
- Results Niesar A, Lancien M, Hong S, Naasz C, Ajibola G, Maswabi K, Sakoi-Mosetlhi M, Batlang O, Moyo S, Mohammed T, Maphorisa C, Carrere L, Roseto I, Hartana CA, Tan TS, Gao C, Parsons E, Hua R, Pretorius Holme M, Lockman S, Powis KM, Carrington M, Makhema J, Yu XG, Kuritzkes DR, Shapiro RL, Lichterfeld M. Immune correlates of HIV-1 rebound during broadly neutralizing antibody treatment in young children. J Clin Invest. 2026 Feb 16;136(4):e193912. doi: 10.1172/JCI193912. eCollection 2026 Feb 16.
- Results Ajibola G, Nelson BS, Niesar A, Hong S, Lancien M, Holme MP, Hughes MD, Yin DE, Jean-Philippe P, Moyo S, Batlang O, Sakoi M, Maphorisa C, Mohammed T, Lockman S, Makhema J, Kuritzkes DR, Lichterfeld M, Shapiro RL. Long-Term Clinical, Immunologic, and Viral Reservoir Outcomes in Children Treated With VRC01LS and 10-1074 Monoclonal Antibodies in the Tatelo Study. Clin Infect Dis. 2026 Feb 25;82(2):e278-e285. doi: 10.1093/cid/ciaf568.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VRC01LS | Monoclonal antibody | 10 mg/kg | Intravenous |
| Subject | VRC01LS | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Zinlirvimab | Monoclonal antibody | 30 mg/kg | Intravenous |