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New treatment option for HIV
Official title A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
ClinicalTrials.gov ID: NCT06812494
What this study is testing
What is VRC07-523LS 400mg?
VRC07-523LS 400mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- Participants cannot have had a blood transfusion within the last 120 days.
- Participants cannot have received experimental treatments within the last 30 days.
- Participants cannot weigh less than 35 kg (about 77 lbs).
- Participants cannot plan to join another clinical trial during this study.
- Participants cannot be pregnant or breastfeeding.
- Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval).
See the full eligibility criteria
- 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.
- Participants cannot have had a blood transfusion within the last 120 days.
- Participants cannot have received experimental treatments within the last 30 days.
- Participants cannot weigh less than 35 kg (about 77 lbs).
- Participants cannot plan to join another clinical trial during this study.
- Participants cannot be pregnant or breastfeeding.
- Participants cannot have received an HIV vaccine in a previous trial (unless it was a placebo, subject to Protocol Safety Review Team's approval).
- Participants cannot have had any live vaccines within the last 14 days or non-live vaccines within the last 7 days.
- Participants cannot have had humanized or human monoclonal antibodies recently, except for certain HIV antibodies more than 12 months ago.
- Participants cannot have had allergy shots within the last 14 days.
- Participants cannot have taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments.
- Participants cannot participate if they have had serious allergic reactions to the components of the study product.
- Participants cannot have received immunoglobulin within the last 60 days.
- Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable.
- Participants cannot have an immune system deficiency.
- Participants cannot have any significant medical condition or abnormal lab results that could impact their health during the study.
- Participants cannot have conditions that make repeated injections or blood draws difficult.
- Participants cannot have conditions requiring active medical treatment that could pose a risk during the study.
- Participants cannot have conditions that could be confused with reactions to the study product.
- Participants cannot have medical, social, or occupational conditions that would interfere with the study.
- Participants cannot have severe psychiatric conditions, like ongoing risk of suicide or recent history of suicide attempts.
- Participants cannot be undergoing treatment for tuberculosis.
- Participants cannot have severe asthma that requires frequent medication or emergency care.
- Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary).
- Participants blood pressure must be below 160/110 mmHg.
- Participants cannot have any diagnosed bleeding disorders.
- 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...
- Participants cannot have had seizures or taken seizure medications in the past 3 years.
- Participants cannot have a history of severe allergic reactions like anaphylaxis, unless it has been well-controlled for at least 5 years.
- Participants cannot have acute or unstable hepatitis B or C, but stable chronic cases may be considered.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Decatur, Georgia, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Rochester, New York, United States
- Chapel Hill, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
- Rio de Janeiro, Rio de Janeiro, Brazil
- Lima, Lima Province, Peru
- Iquitos, Maynas, Peru
- Callao, Provincia Constitucional del Callao, Peru
- Lima, Peru
- Johannesburg, Gaunteng, South Africa
- Chatsworth, KwaZulu-Natal, South Africa
- Soshanguve-H, Soshanguve, South Africa
- Cape Town, Western Cape, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Decatur, Georgia, United States; Boston, Massachusetts, United States; New York, New York, United States; Rochester, New York, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.