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NCT06812494 · ClinicalTrials.gov registry record · Phase 2
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
A Phase 2 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06812494: Recruiting Phase 2 study of HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06812494 is a Phase 2 study of HIV that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 200 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06812494, a Phase 2 study of HIV, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
Conditions Studied
Interventions
- BIOLOGICAL VRC07-523LS 400mg
- BIOLOGICAL PGT121.414.LS 400mg
- BIOLOGICAL PGDM1400LS 400mg
- BIOLOGICAL VRC07-523LS 3200mg
- BIOLOGICAL PGT121.414.LS 1600mg
Study Locations (20)
Massachusetts
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) - Boston
- Fenway Health - Boston
- BIDMC VCRS (Site ID# 32077) - Boston
Other
- Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS - Rio de Janeiro
- CITBM CRS (Site ID 31970) - Callao
- Via Libre (Site ID 31909) - Lima
New York
- Columbia P&S CRS - New York
- University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467) - Rochester
Pennsylvania
- Penn Prevention CRS - Philadelphia
- University of Pittsburgh CRS (Site 1001) - Pittsburgh
Alabama
- Alabama CRA (Site #31788) - Birmingham
California
- Bridge HIV, San Francisco Department of Public Health - San Francisco
Georgia
- The Hope Clinic of the Emory Vaccine Research Center; Emory University - Decatur
North Carolina
- Chapel Hill CRS (Site #3201) - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-03-07 |
| Est. Completion | 2027-09-15 |
| Phase | Phase 2 |
What NCT06812494 shows while recruiting
NCT06812494 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (54% lower).
The record links to 1 condition, with HIV appearing as the primary indexed condition, and to 5 interventions - of which VRC07-523LS 400mg is the first listed.
NCT06812494 names 20 study sites across 14 states, led by Massachusetts, Other, New York.
Frequently Asked Questions
What is clinical trial NCT06812494 about?
NCT06812494 is a clinical study titled "A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV". HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HI...
What is the current status of trial NCT06812494?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2025-03-07. Estimated completion is 2027-09-15.
What conditions does trial NCT06812494 study?
This clinical trial studies the following conditions: HIV.
What interventions are being tested in trial NCT06812494?
The interventions under investigation include: VRC07-523LS 400mg (BIOLOGICAL), PGT121.414.LS 400mg (BIOLOGICAL), PGDM1400LS 400mg (BIOLOGICAL), VRC07-523LS 3200mg (BIOLOGICAL), PGT121.414.LS 1600mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT06812494?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06812494 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HIV
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06812494's enrollment target sits among peer trials
200 103rd of 303 higher than 188 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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