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

Korábbi kezelés

• Participants cannot have received experimental treatments within the last 30 days.
• 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 taken immunosuppressive drugs within the last 30 days, with some exceptions like nasal sprays or mild skin treatments.
• Participants cannot have received immunoglobulin within the last 60 days.
• Participants cannot have severe asthma that requires frequent medication or emergency care.

Más betegség

• 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 participate if they have had serious allergic reactions to the components of the study product.
• Participants cannot have an autoimmune disease that requires immunosuppressive treatment, unless it's mild and stable.
• 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 diabetes mellitus (DM) (well-controlled Type 2 DM or an isolated history of gestational diabetes are not exclusionary).
• 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 period of the study
• 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.

Egyéb

• Participants cannot have had a blood transfusion within the last 120 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 an immune system deficiency.
• Participants blood pressure must be below 160/110 mmHg.

• 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.