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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT06430905
Eligibility Criteria:
Inclusion Criteria:
* Participants 18 to 65 years of age.
* Confirmed HIV infection as documented by medical records or confirmatory HIV testing at screening.
* Must be on stable suppressive antiretroviral treatment (ART) for at least 48 weeks prior to screening.
* Must have plasma HIV RNA levels of \<50 copies/mL (or lower limit of quantitation) for at least 48 weeks prior to enrollment.
* Must have a cluster of differentiation (CD)4+ cell count \>450 cells/mm3 and CD4+ cell % of ≥15% obtained within 40 days prior to enrollment.
* Is in good general health according to the clinical judgment of the site Investigator.
Exclusion Criteria:
* History of hypersensitivity or other contraindication to any of the components of the study interventions as determined by the Investigator.
* HIV-associated malignancy according to the National Cancer Institute (including Kaposi's sarcoma), and any type of lymphoma or virus-associated cancers.
* History of HIV-associated neurocognitive disease or progressive multifocal leukoencephalopathy.
* More than stage 2 HIV-related illness based on the Revised Surveillance Case Definition for HIV Infection (CDC 2014).
* Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 156 weeks (i.e., 3 years) prior to enrollment.
* Known history of hepatitis B virus (defined as hepatitis B surface antigen reactive) or known active hepatitis C virus infection (defined as hepatitis C virus RNA is detected \[qualitative\]).
* Current untreated or incompletely treated active TB disease or untreated latent TB infection.
* Has any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive study treatment, or interfere with the interpretation of the study results.
* Is a previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
* Received non-HIV experimental vaccine(s) within the last 1 year.
* Has congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site Investigator, such as history of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the Investigator within 24 weeks prior to the start of study therapy.
* Received blood products or immunoglobulin within 16 weeks prior to enrollment.
* Received systemic steroids at a dose of ≥10 mg/day (prednisone equivalent) for \<30 within 14 days or for ≥30 days within 28 days of first dose of study treatment.
* Received any vaccine within 4 weeks prior to enrollment.
* Initiated antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary).
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or contraindicate participation in this study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
* Is pregnant or breastfeeding or expecting to conceive or father children starting with the screening visit through a minimum of 12 weeks after the last dose of trial treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06430905
Study Brief:
Protocol Section:
NCT06430905