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New treatment option for HIV (Human Immunodeficiency Virus)
Official title The DART DELIVER-02 Study
ClinicalTrials.gov ID: NCT07217379
What this study is testing
What is MGD020?
MGD020 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hiv (human immunodeficiency virus).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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
You likely can't join 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
- At US sites, Hepatitis C (HCV) antibody negative result at screening or, if the participant is HCV antibody positive, a negative HCV RNA at screening; at Kenyan sites, participants must be HCV antibody negative at...
- Hepatitis B surface antigen (HBsAg) negative at screening.
- Women of child-bearing potential must have a negative serum pregnancy test with a sensitivity of at least 25 milli-international unit (mIU) per milliliter at screening Note: Women of child-bearing potential is defined...
- For participants with partners who do not have HIV or HIV status unknown, willingness to abstain from sexual intercourse, use a condom, and/or advise partner(s) to use pre-exposure prophylaxis (PrEP) consistently during...
- All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) while on study and for 6 months...
- All men and women participating in sexual activity that could lead to pregnancy must agree to consistently use at least one of the following forms of birth control for at least 21 days prior to Visit 3 (Day 0) and for 6...
- Condoms (internal or external) with or without a spermicidal agent
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Tubal ligation
- Hormone-based contraceptive
- Agrees not to enroll on another study of an investigational agent during the study period, defined as any unlicensed investigational drug not yet approved for use in humans.
- Willingness to defer live vaccinations (e.g., varicella, measles, mumps, rubella (MMR), yellow fever, oral polio, Mpox) from 30 days prior to enrollment through week 16.
- Willingness to defer routine vaccination, including influenza, from 14 days prior to enrollment through Week 16 of the study. Note: Individuals who require vaccination will delay enrollment until 14 days after...
- Agrees to refrain from blood donation during the course of the study.
- Participants with Type 2 diabetes must have a hemoglobin A1C \<8 or a fasting glucose ≤ 125 mg/dL; mmol/L at screening.
- Adequate organ function as indicated by the laboratory values in Table 7 of the protocol.
What rules you out
- 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...
- 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...
- Use of the following medications that carry risk of torsade des pointes: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, domperidone...
- 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...
- 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...
- 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...
- 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
- History of pulmonary embolism or deep venous thrombosis.
- History of hereditary angioedema, acquired angioedema or idiopathic angioedema.
- Known allergy/sensitivity or hypersensitivity to components of study drugs.
- Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
- Daily steroid or long-acting beta-agonist prevention
- Hospitalization in the last two years
- Active chronic skin problems such as eczema or psoriasis not controlled with topical treatments.
- Inability to communicate effectively with study personnel.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
- Eldoret, Kenya
- Kericho, Kenya
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States; Eldoret, Kenya; Kericho, Kenya. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.