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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites reduced: 19 → 16 locationsv6
  2. Study sites revised (19)v5 See this version in full on ClinicalTrials.gov ↗
  3. Recruitment opened Start date: Jun 2, 2026 to Sep 15, 2026 · Trial sites expanded: 11 → 19 locationsv4 Show 2 more changesShow less
    • Start date: Jun 2, 2026 to Sep 15, 2026
    • Trial sites expanded: 11 → 19 locations
  4. Study sites: 9 to 11v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 planned pause in antiretroviral therapy affects these immune responses.
Trial Details
NCT Number NCT07569029
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Department of Health and Human Services, Duke University
Conditions HIV
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov