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Suspended
NCT07217379
The DART DELIVER-02 Study
Conditions: HIV (Human Immunodeficiency Virus)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 24
Sponsor: University of North Carolina, Chapel Hill
Location: University of North Carolina Chapel Hill North Carolina
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.
Eligibility Criteria
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 duration of the trial.
7. Continuous ART for a minimum of 24 months prior to screening, defined as not missing more than 9 consecutive days in the last 3 months prior to screening.
8. No change in any ART medication in the 30 days prior to screening.
9. Permitted ART regimens include:
• At least 3 ART agents (not counting ritonavir or cobicistat as one of the agents if less than a 200 mg total daily dose). One of the agents must include an integrase inhibitor, NNRTI (Non-Nucleoside Reverse Transcriptase Inhibitors), or a boosted-PI (protease inhibitor).
OR
• Two (2) ART agents in which one of the agents is either a boosted protease inhibitor or an integrase inhibitor.
Note: Other potent fully suppressive antiretroviral combinations will be considered on a case-by-case basis.
10. Participants must be determined to have an alternative ART regimen that can be constructed to assure availability of an effective option if assigned to Arm B and TTI leads to selection of virus resistant to the current regimen.
11. Ability and willingness of participant to continue ART throughout the study or temporarily discontinue ART for up to 8 weeks (for Arm B) under closely monitored supervision.
12. Plasma HIV-1 RNA \
Source: ClinicalTrials.gov (NCT07217379). StuddyBuddy aggregates publicly available trial information.