NCT02850016

Romidepsin Plus 3BNC117 Phase 2a Study

A Phase 2a, Randomized Study of Romidepsin With or Without 3BNC117 to Evaluate the Effects on the HIV-1 Reservoir (ROADMAP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Rockefeller University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized interventional phase 2a trial of 3BNC117 and romidepsin in human immunodeficiency (HIV-1) infected patients on ART, conducted as a multi-center study at the Department of Infectious Diseases, Aarhus University Hospital, Denmark, the Rockefeller University Hospital, USA, and the University Hospital of Cologne, Germany. Participants will be randomized 1:1 in a non-blinded fashion to receive one of two regimens: A) Two treatment cycles each consisting of one 3BNC117 infusion (30mg/kg) + three romidepsin infusions (5mg/m2); or B) Two treatment cycles each consisting of three romidepsin infusions (5mg/m2). ART will be discontinued 16 weeks after the start of the second treatment cycle (analytical treatment interruption, ATI) and subjects will be monitored weekly for safety and viral rebound. The targeted enrollment is 30 subjects (15 per arm). Leukapheresis will be performed before and after the two treatment cycles to guarantee sufficient material to investigate changes in the reservoir after the interventions. The following criteria will require resumption of ART: * CD4+ T cell-count \<350 cells/mm³ (confirmed by repeat measurement) * 2 consecutive plasma HIV-1 RNA measurements ≥ 200 copies/mL or above their setpoint viremia (if documented) * Subject request * Continued ART interruption will, in the opinion of the investigator or study advisers, pose an unacceptable risk to the subject. If HIV-1 RNA remains undetectable at week 36, subjects will be offered to continue off ART with close monitoring, in conjunction with the subject's primary medical provider, as long as HIV-1 viral rebound does not occur. ART resumption will follow same criteria as detailed above. All subjects will be followed for a total of 48 weeks from enrollment.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
DRUG	3BNC117	Intravenous Infusion of 3BNC117
DRUG	Romidepsin	Intravenous Infusion of Romidepsin

Timeline

• Start date: 2017-01-06
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2016-07-29
• Last updated: 2022-07-14
• Results posted: 2022-07-14

Locations

3 sites across 3 countries: United States, Denmark, Germany