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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. HIV infection initially documented by at least one of the following at any time prior to study entry: * any licensed rapid HIV test * HIV antibody test * HIV Ag/Ab assay …and documented confirmation by at least one of the following at any time prior to study entry: * licensed Western blot of HIV ½ antibody differentiation immunoassay * a second antibody test by a method other than the initial rapid HIV and/or HIV antibody assay * HIV-1 antigen, plasma HIV-1 RNA viral assay. 2. Ages ≥ 18 to ≤ 65 years old 3. Able and willing to give written infor…
Interventions
- DrugMGD020
Administered intravenously at 300mg/kg over 60 minutes.
- DrugMGD014
Administered intravenously at 300mg/kg over 60 minutes.
- DrugVorinostat
Administered orally at 400 mg every 72 hours.
- OtherTemporary treatment interruption
Discontinuation of antiretroviral therapy (ART) through Week 8. If a participant meets protocol-defined ART restart criteria during the temporary treatment interruption (TTI), ART will be reinitiated immediately. Participants who do not meet restart criteria will remain off ART and continue weekly monitoring until Week 8, at which point ART will be resumed.
Locations (3)
- University of North CarolinaChapel Hill, North Carolina
- Moi University Clinical Research CenterEldoret
- Kenya Medical Research Institute/Walter Reed ProjectKericho