The DART DELIVER-02 Study

Recruiting now · Phase 1

Conditions studied: HIV (Human Immunodeficiency Virus)

In brief

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.

Key facts

Study ID

NCT07217379

Run by

University of North Carolina, Chapel Hill

People needed

24

Starts

2025-10-02

Expected to finish

2027-02-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Ages ≥ 18 to ≤ 65 years old
• Able and willing to give written informed consent.
• Able and willing to stay in contact with site during the duration of the trial
• Able and willing to provide adequate locator information.
• Able and willing to comply with all study requirements through duration of the trial.
• 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.
• No change in any ART medication in the 30 days prior to screening.
• 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.
• 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.
• 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.
• Plasma HIV-1 RNA <50 copies/mL at 2 time points in the 24 months prior to screening and never ≥50 copies/mL on 2 consecutive time points in the last 24 months.
• No HIV RNA ≥200 copies/mL in the 6 months prior to screening.
• CD4 cell count ≥ 400 cells/mm3 performed at screening.

You may not qualify if…

• Women who are pregnant or breastfeeding.
• Untreated syphilis infection defined as a positive rapid plasma reagin (RPR) without clear documentation of treatment.
• Current treatment for HCV or HCV treatment within 6 months prior to enrollment.
• Received any infusion blood product or hematopoetic growth factors within 3 months prior to enrollment.
• Started ART within 90 days of diagnosis with acute HIV-1 infection.
• Use of antiretrovirals that might interfere with MGD014 or MGD020: maraviroc (Selzentry), enfuvirtide (T-20), fostemsavir (Rubokia), Ibalizumab (Trogarzo).
• Use of long-acting antiretroviral regimens given potential TTI.
• Use of any of the following agents within 90 days prior to enrollment: immunomodulatory, cytokine, or growth stimulating factors such as systemic cytotoxic chemotherapy or immune globulin, interferons, coumadin, warfarin, or other Coumadin derivative anticoagulants.
• Intent to use immunomodulatory treatment during the study.
• Use of systemic corticosteroids within 30 days prior to enrollment, or anticipated need for periodic use of systemic corticosteroids during the study.
• Note: Participants receiving stable physiologic doses of glucocorticoids, defined as the equivalent of prednisone ≤10 mg/day, are not excluded.
• Participants receiving inhaled, intranasal, topical, intermittent intra-articular corticosteroids, or topical imiquimod are not excluded.
• Concomitant use of oral/systemic /intra-articular/inhaled/intranasal corticosteroids is prohibited for participants receiving ritonavir or cobicistat.
• Use of the following medications that carry risk of torsade des pointes: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, terfenadine, thioridazine.
• Receipt of compounds with histone deacetylase (HDAC) inhibitor-like activity, such as valproic acid within the last 30 days. Potential participants may enroll after a 30-day washout period.
• Use of any other investigational treatment within 6 months prior to enrollment, with the exception of Phase 2 or higher studies of antiretroviral agents.
• Note: Co-enrollment with other studies under an investigational new drug (IND) using an FDA approved medication that is not otherwise listed as prohibited will be considered on a case-by-case basis.
• Any serious illness requiring systemic treatment or hospitalization, the participant must either complete therapy or be clinically stable on therapy, in the opinion of the site investigator, for at least 90 days prior to enrollment.
• Any medical, psychiatric, substance abuse, occupational or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety.
• History of malignancy within the last 3 years. Note: History of non-melanoma skin cancer (e.g., basal cell carcinoma or squamous cell skin cancer) is not exclusionary with documented resolution per topical treatment or complete resection determined by a dermatologist at least 3 months prior to enrollment.
• Immune deficiency other than that caused by HIV infection.
• Blood pressure consistently >150 mm Hg systolic and >100 mm Hg diastolic in the prior 6 months.
• Grade 2 or higher QT prolongation as measured by corrected QT interval (QTc) as calculated by the Fridericia formula at screening.
• History of acute or chronic pancreatitis.
• Bleeding disorder including factor deficiency, coagulopathy or platelet disorder that requires special precautions (easy bruising without a formal diagnosis is not exclusionary) or chronic anticoagulation

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• Moi University Clinical Research Center — Eldoret, Kenya
• Kenya Medical Research Institute/Walter Reed Project — Kericho, Kenya

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.