IGHID 12430 - Deliver-02 - A Phase 1, Open Label, Randomized Study To Evaluate The Safety And Tolerability Of MGD014 And MGD020 With A Latency Reversal Agent Versus Temporary Treatment Interruption In Persons With HIV-1 On Antiretroviral Therapy
University of North Carolina, Chapel Hill
Summary
This research study aims to find out how safe and well tolerated the experimental study drugs are when given to persons with HIV (PWH) taking antiretroviral therapy (ART). The study treatments are MGD014 and MGD020, which are two antibodies developed specifically for HIV, and Vorinostat, an oral medication to help expose HIV in cells to the antibodies. The study will measure the impact of study treatment on non-active HIV in cells, and how long MGD014 and MGD020 stay in the body after they are given. In this study, participants will be randomly assigned to one of three groups. All participants receive MGD014 and MGD020, given sequentially as infusions through an IV for 4 doses. Participants in one group (group A) receive only MGD014 and MGD020. Participants in another group (group B) will stop taking their ART therapy for up to 8 weeks (a temporary treatment interruption (TTI)) while receiving MGD014 and MGD020. Participants in the third group (group C) receive Vorinostat in addition to MGD014 and MGD020. Total time of participation is about 8 months and involves 13 or 18 visits, depending on group assignment.
Description
This study is a phase 1, pilot, open-label study of MGD014 in combination with MGD020 in PWH on ART. The study is designed to characterize the safety, tolerability, pharmacokinetics (PK), and immunogenicity of the study drugs alone, and in combination with an latency reversal agent (LRA) or a TTI. Participants will be enrolled, undergo an initial evaluation and baseline sample collections, and then be randomized to 1 of 3 arms as follows: Arm A: Continue baseline ART and receive biweekly MGD014/ MGD020 infusions at Day 0, weeks 2, 4 and 6. Arm B: Initiate biweekly MGD014/ MGD020 infusions at…