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
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.
• Participants need to be between 18 and 65 years old.
• Participants must have access to a participating clinical research site and be willing to follow the study schedule.
• Participants should understand the study details and be willing to give informed consent.
• Participants must agree not to join any other clinical trials until they finish this study.
• Participants must be willing to receive HIV test results.
• Participants should be open to discussing HIV prevention.
• Clinic staff should assess participants as having a low risk of getting HIV, and participants must commit to avoiding high-risk behaviors during the study.
• Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status.
• White Blood Cells (WBC): Should be within the normal range or approved by a site clinician.
• Platelets: At least 100,000 cells/mm³.
• Alanine aminotransferase (ALT): Less than 5 times the upper normal limit.
• Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times your baseline level.
• Participants must test negative for HIV-1 and HIV-2.
• Participants urine protein must be negative or trace.
⁃ Reproductive Status:
• Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting the study.
• Participants must agree to use effective birth control from at least 21 days before joining the study until the end of the study.
• Participants must agree not to try to become pregnant through any method during the study.