drugset / Trial / NCT02850016
Romidepsin Plus 3BNC117 Phase 2a Study
Phase 2
Completed
48 enrolled
Rockefeller University
Aarhus University Hospital · collabUniversity Hospital of Cologne · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals during an analytical interruption of ART.
Timeline
- Start
- 2017-01-06
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
Outcome
Missed primary endpoint
paper 18 days (IQR 14-28) in the 3BNC117 plus romidepsin group and 28 days (21-35) in the romidepsin group B (p=0·0016). PMID 35544074 ↗
paper The combination of 3BNC117 and romidepsin was safe but did not delay viral rebound during analytic treatment interruptions PMID 35544074 ↗
Publications
- Gruell H, Gunst JD, Cohen YZ, Pahus MH, Malin JJ, Platten M, Millard KG, Tolstrup M, Jones RB, Conce Alberto WD, Lorenzi JCC, Oliveira TY, Kummerle T, Suarez I, Unson-O'Brien C, Nogueira L, Olesen R, Ostergaard L, Nielsen H, Lehmann C, Nussenzweig MC, Fatkenheuer G, Klein F, Caskey M, Sogaard OS. Effect of 3BNC117 and romidepsin on the HIV-1 reservoir in people taking suppressive antiretroviral therapy (ROADMAP): a randomised, open-label, phase 2A trial. Lancet Microbe. 2022 Mar;3(3):e203-e214. doi: 10.1016/S2666-5247(21)00239-1. Epub 2022 Jan 24.
- Valente PK, Wu Y, Cohen YZ, Caskey M, Meyers K. Behavioral and social science research to support development of educational materials for clinical trials of broadly neutralizing antibodies for HIV treatment and prevention. Clin Trials. 2021 Feb;18(1):17-27. doi: 10.1177/1740774520948042. Epub 2020 Aug 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LAFUVITUG | Monoclonal antibody | 30 mg/kg | Intravenous |
| Subject | Romidepsin | Peptide | 5 mg/m2 | Intravenous |