Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT03570918
Eligibility Criteria:
Inclusion Criteria:
* Ability and willingness of participant to provide written informed consent.
* HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
* On a potent, stable, continuous ART regimen for ≥ 24 months prior to Screening.
* Plasma HIV-1 RNA \< 50 copies/mL at two time points in the previous 12 months prior to screening (one time point can be screening) and never ≥ 50 copies/mL on 2 consecutive time points in the last 24 months.
* Adequate organ function based on acceptable laboratory parameters.
Exclusion Criteria:
* Women of childbearing potential defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or menopause.
* History or other evidence of severe illness, immunodeficiency other than HIV, or any other condition that would make the potential participant unsuitable for study.
* History or other evidence of any condition or process for which signs or symptoms could be confused with reactions to MGD014.
* History of any HIV immunotherapy or HIV vaccine except for MGD014 within 12 months prior to screening.
* History of clinically significant cardiovascular disease, severe allergic reactions, malignancy (except non-melanoma skin cancer) within 5 years, seizure disorder within 2 years, organ/tissue transplant, autoimmune disease, unstable asthma, bleeding disorder.
* Evidence of active viral, or antifungal treatment within 7 days prior to the initiation of study drug
* Active, asymptomatic, or suspected COVID-19/SARS-CoV-2 infection.
* Active, untreated syphilis.
* Use of blood products, cytokine therapy, growth-stimulating factors, cytotoxic chemotherapy or investigational therapy within 90 days.
* Current use of the antivirals maraviroc and/or enfuvirtide.
* Any vaccination with exception of flu vaccine within 30 days of screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03570918
Study Brief:
Protocol Section:
NCT03570918