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.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of participants experiencing local Adverse Events (AEs)
Timeframe: At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing local AEs
Timeframe: At Days 1, 4, 7, 169 and 173
Number of participants experiencing systemic AEs
Timeframe: At Days 1, 4, 7, 169 and 173
Percentage of participants experiencing systemic AEs
Timeframe: At Days 1, 4, 7, 169 and 173
Number of participants experiencing unsolicited AEs
Timeframe: Baseline through Week 48
Percentage of participants experiencing unsolicited AEs
Timeframe: Baseline through Week 48
Number of participants experiencing Serious Adverse Events
Timeframe: Baseline through Week 48
Number of participants who discontinue study product administration and terminate the study early
Timeframe: Baseline through Week 48
Percentage of participants who discontinue study product administration and terminate the study early
Timeframe: Baseline through Week 48
Change from baseline in ALT
Timeframe: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in aspartate aminotransferase (AST)
Timeframe: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in alkaline phosphatase (Alk Phos)
Timeframe: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in creatinine
Timeframe: Baseline, Days 1, 57, 169, 225 and 337
Change from baseline in Complete Blood Count (CBC)
Timeframe: Baseline, Days 1, 57, 169, 225 and 337