The DART DELIVER-02 Study
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 expo
| Condition(s) | HIV (Human Immunodeficiency Virus) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 informed consent. 4. Able and willing to stay in contact with site during the duration of the trial 5. Able and willing to provide adequate locator information. 6. Able and willing to comply with all study requirements through dura |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Locations | Chapel Hill, North Carolina, United States; Eldoret, Kenya; Kericho, Kenya |
| Start date | 2025-10-02 |
| NCT ID | NCT07217379 |
| Official listing | https://clinicaltrials.gov/study/NCT07217379 |