Trial studying safety and effects for HIV
Official title A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1
ClinicalTrials.gov ID: NCT07390955
What this study is testing
What is ePGT121v1-LS?
This is an investigational antibody being studied as a potential treatment for HIV. It is designed to bind to a specific part of the HIV virus to help neutralize it in the blood.
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
- This study checks if these antibodies are safe and finds the right dose. It also looks at how the body handles the drugs and if they work well together.
- Who it's for
- Healthy adults who do not have HIV.
- What's involved
- Participants will get antibody shots either into a vein or under the skin. They will have blood tests and check-ups to monitor safety and side effects.
- Time commitment
- The study lasts 24 to 48 weeks, depending on the group, with regular clinic visits.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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 55. Healthy volunteers may be eligible.
You may be able to join if
- Age 18 to 55 years.
- Can visit a participating clinic and is willing to stay in the study for its full duration.
- Understands the study and is able and willing to give informed consent.
- Agrees not to join another experimental study until the final required clinic visit.
- In good overall health based on medical history, physical exam, and screening lab tests.
You likely can't join if
- Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment).
- Took any experimental (investigational) research drug within 30 days before the first study dose.
- Weighs less than 35 kg or more than 115 kg.
- Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study.
- Pregnant or breastfeeding.
- Previously received an HIV vaccine in a vaccine trial. If a potential participant received placebo/control only, eligibility will be decided case by...
See the full eligibility criteria
- Age 18 to 55 years.
- Can visit a participating clinic and is willing to stay in the study for its full duration.
- Understands the study and is able and willing to give informed consent.
- Agrees not to join another experimental study until the final required clinic visit.
- In good overall health based on medical history, physical exam, and screening lab tests.
- Willing to receive HIV test results.
- Willing to discuss personal risk of getting HIV and to have HIV prevention counseling.
- Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit.
- Women: at least 11.0 g/dL
- Men: at least 13.0 g/dL
- White blood cell count between 2,500 and 12,000 cells/mm³.
- White blood cell differential is normal or acceptable to clinic staff.
- Platelet count between 125,000 and 550,000 cells/mm³.
- ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal.
- Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal.
- Negative tests for HIV 1 and HIV 2.
- Negative hepatitis B surface antigen.
- Negative hepatitis C antibody, or a negative HCV PCR if the antibody test is positive.
- Urine protein is negative or only trace.
- If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment.
- Women who could become pregnant agree to use effective birth control for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit.
- Women who could become pregnant also agree not to try to become pregnant using methods like egg retrieval, artificial insemination, or in vitro fertilization starting at least 21 days before enrollment and continuing...
- Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment).
- Took any experimental (investigational) research drug within 30 days before the first study dose.
- Weighs less than 35 kg or more than 115 kg.
- Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study.
- Pregnant or breastfeeding.
- Previously received an HIV vaccine in a vaccine trial. If a potential participant received placebo/control only, eligibility will be decided case by case by the safety review team.
- Received any non HIV vaccine within 14 days before enrollment or plan to get one within 14 days after enrollment.
- Received humanized or human monoclonal antibodies (mAbs), whether approved or experimental.
- Previously received monoclonal antibodies that target HIV.
- Receiving allergy shots within 30 days before the first study dose or scheduled within 14 days after the first dose.
- Took immune suppressing medicines within 30 days before the first study dose. Not excluded: nasal steroid sprays; inhaled steroids (see asthma item); topical steroids for mild skin conditions
- History of serious reactions to components of the study products, including anaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), or abdominal pain.
- Received immunoglobulin within 60 days before the first study dose (separate from mAbs listed above).
- Autoimmune disease that is not mild, stable, and uncomplicated. Mild, stable cases not needing immune suppressing drugs may be allowed if the investigator judges low risk.
- Immunodeficiency.
- Affect the immune system or its response,
- Require medicines that affect the immune system,
- Make repeated injections, infusions, or blood draws unsafe or not feasible (for example, very difficult veins),
- Need active medical care to prevent serious harm during the study,
- Have symptoms that could be mistaken for reactions to the study product,
- Or is otherwise listed among these exclusions.
- Any medical or skin condition, social situation, or job duty that, in the investigator's judgment, would interfere with following the study, safety assessments, or giving informed consent.
- A psychiatric condition that prevents following the study. Specifically excluded: psychosis, current suicide risk, or a suicide attempt within the past 3 years.
- Currently on tuberculosis treatment.
- Asthma that is more than mild and well controlled.
- Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or a past history of gestational diabetes.
- High blood pressure (hypertension).
- Diagnosed bleeding disorder.
- Cancer. Not excluded: surgically removed cancers with good assurance of cure or very low risk of recurrence during the study period.
- Seizure disorder with any seizure in the past 3 years, or use of seizure prevention or seizure treatment medicines at any time in the past 3 years.
- Asplenia (no functioning spleen).
- History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded if due to a known trigger and there have been no reactions for at least 5 years, showing successful avoidance of the trigger.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
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, but 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 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; San Francisco, California, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.