A Trial to Evaluate the Safety and Tolerability of DV700P-RNA and DV701B1.1-RNA Immunization in Combination With Antiretroviral Analytical Treatment Interruption (ATI) in People Living With HIV for Elicitation of V3-glycan Antibodies

Recruiting Phase 1 Interventional Study
HIV
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
42 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
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About This Trial
This phase 1 study will evaluate the safety, tolerability, and immune responses of two experimental mRNA HIV vaccines in adults living with HIV who are in overall good health. The study will enroll about 42 participants at multiple study sites. Researchers will assess whether these vaccines can start or strengthen antibody responses against HIV. The study will also evaluate how a closely monitored…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Able and willing to provide informed consent. * Age 18 to 60 years. * Documented HIV infection. * Lowest (nadir) CD4+ count between 250 and 450 cells/mm³. * On stable combination antiretroviral therapy (ART) for at least 48 weeks prior to screening. * Plasma HIV RNA \<50 copie…
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