Phase 2 HIV and AIDS Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of primary HIV-1 infection
• People aged 18 to 70 years old at the time of screening
• People who are willing to use an effective method of contraception from the start of the trial until the end of the follow-up period
• People who have a negative pregnancy test result at the time of screening, where this applies
• People who agree not to try to become pregnant, including through methods such as artificial insemination or IVF, until after the last required trial visit, where this applies
• People who are willing to provide written informed consent
• People who have regular health insurance coverage
• People who are willing to follow the trial's requirements, including travelling for medication administration and pausing their usual HIV treatment at certain points
• People who are willing to be vaccinated against COVID-19 in line with current recommendations

Who may not be able to join:

• People who are currently taking part in another clinical trial that requires extra blood samples (participation in an observational study that does not require extra blood samples may be permitted — confirm with trial site)
• People for whom using condoms or having a partner use PrEP would be difficult or not possible
• People who are pregnant or breastfeeding
• People who are under legal guardianship or a similar legal protection arrangement
• People who have any active infection or condition, including active hepatitis C, hepatitis B, COVID-19 (SARS-CoV-2), or active tuberculosis
• People with a history of ischemic heart disease, including heart attack, stable or unstable angina, or stroke
• People with a current or past history of cancer, except for certain skin cancers (squamous cell skin cancers)
• People with a history of, or current, serious inflammatory eye conditions such as uveitis, choroiditis, or optic neuropathy
• People who have a medical condition that means pausing HIV treatment would not be safe for them
• People with existing or past conditions that would make receiving injections of monoclonal antibodies (a type of laboratory-made protein used as treatment) unsuitable
• People who have used systemic steroids, immune-suppressing medications, or cancer treatments within the last 6 months
• People with a history of severe reactions to a vaccine or a drug given by infusion, or a history of severe allergic reactions
• People with any known reason they should not receive the trial medications 3BNC117-LS or 10-1074-LS, including known hypersensitivity to these substances
• People whose blood clotting function (prothrombin level) is below 50% (confirm with trial site)
• People whose kidney function is below a certain level, measured as a creatinine clearance of less than 60 mL/min (confirm with trial site)
• People with significantly elevated liver function test results or bilirubin levels (10 times or more above the normal upper limit) (confirm with trial site)
• People whose HIV infection involves only the HIV-2 strain rather than HIV-1
• People who have planned absences that could affect their ability to participate, such as extended travel abroad or a planned move

Important: Always verify eligibility with the trial site directly before applying.