RECRUITING

A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV

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Conditions

HIVHIV PreventionbnAbMonoclonal antibodyIntravenousTriple combinationVRC07-523LSPGT121.414.LSPGDM1400LS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-07
Study Completion:2027-09-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06812494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants need to be between 18 and 65 years old.
  2. * Participants must have access to a participating clinical research site and be willing to follow the study schedule.
  3. * Participants should understand the study details and be willing to give informed consent.
  4. * Participants must agree not to join any other clinical trials until they finish this study.
  5. * Participants must be willing to receive HIV test results.
  6. * Participants should be open to discussing HIV prevention.
  7. * 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.
  8. * Hemoglobin: Participant meets minimum levels depending on gender and hormone therapy status.
  9. * White Blood Cells (WBC): Should be within the normal range or approved by a site clinician.
  10. * Platelets: At least 100,000 cells/mm³.
  11. * Alanine aminotransferase (ALT): Less than 5 times the upper normal limit.
  12. * Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times your baseline level.
  13. * Participants must test negative for HIV-1 and HIV-2.
  14. * Participants urine protein must be negative or trace.
  15. * Participants of child-bearing potential need a negative pregnancy test within 72 hours before starting the study.
  16. * Participants must agree to use effective birth control from at least 21 days before joining the study until the end of the study.
  17. * Participants must agree not to try to become pregnant through any method during the study.
  1. * Participants cannot have had a blood transfusion within the last 120 days.
  2. * Participants cannot have received experimental treatments within the last 30 days.
  3. * Participants cannot weigh less than 35 kg (about 77 lbs).
  4. * Participants cannot plan to join another clinical trial during this study.
  5. * Participants cannot be pregnant or breastfeeding.
  6. * Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval).
  7. * Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days.
  8. * Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago.
  9. * Participants cannot have had allergy shots within the last 14 days.
  10. * Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments.
  11. * Participants cannot participate if they have had serious allergic reactions to the components of the study product.
  12. * Participants cannot have received immunoglobulin within the last 60 days.
  13. * Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable.
  14. * Participants cannot have an immune system deficiency.
  15. * Participants cannot have any significant medical condition or abnormal lab results that could impact their health during the study.
  16. * Participants cannot have conditions that make repeated injections or blood draws difficult.
  17. * Participants cannot have conditions requiring active medical treatment that could pose a risk during the study.
  18. * Participants cannot have conditions that could be confused with reactions to the study product.
  19. * Participants cannot have medical, social, or occupational conditions that would interfere with the study.
  20. * Participants cannot have severe psychiatric conditions, like ongoing risk of suicide or recent history of suicide attempts.
  21. * Participants cannot be undergoing treatment for tuberculosis.
  22. * Participants cannot have severe asthma that requires frequent medication or emergency care.
  23. * Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary).
  24. * Participants blood pressure must be below 160/110 mmHg.
  25. * Participants cannot have any diagnosed bleeding disorders.
  26. * Participants cannot have active cancer but may be eligible if, in the investigator's estimation, they have a reasonable assurance of sustained cure, or are unlikely to experience recurrence of malignancy during the period of the study
  27. * Participants cannot have had seizures or taken seizure medications in the past 3 years.
  28. * Participants cannot have a history of severe allergic reactions like anaphylaxis, unless it has been well-controlled for at least 5 years.
  29. * Participants cannot have acute or unstable hepatitis B or C, but stable chronic cases may be considered.

Contacts and Locations

Study Locations (Sites)

Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
United States
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, 30030
United States
Fenway Health
Boston, Massachusetts, 02215-4302
United States
Chapel Hill CRS
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-07
Study Completion Date2027-09-15

Study Record Updates

Study Start Date2025-03-07
Study Completion Date2027-09-15

Terms related to this study

Keywords Provided by Researchers

  • HIV Prevention
  • bnAb
  • Monoclonal antibody
  • Intravenous
  • Triple combination
  • VRC07-523LS
  • PGT121.414.LS
  • PGDM1400LS

Additional Relevant MeSH Terms

  • HIV