Phase 3 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 are cisgender men, non-binary individuals assigned male at birth, or transgender women or men
• People who report having had anal sex with a person who was assigned male at birth in the last six months
• People aged between 18 and 30 years
• People who are visiting a study clinic to seek PrEP (a medication that helps prevent HIV)
• People who have never previously used either of the two PrEP options being studied in this trial (cabotegravir long-acting injections or the daily pill TDF/FTC)
• People who are willing and able to sign a consent form and follow the study requirements
• People who test negative for HIV at enrolment, including both rapid tests and a more detailed blood test (required for those choosing the injectable option)
• People with no known liver problems — those who report liver disease will have enrolment delayed until liver test results are reviewed, and people whose liver function test results are above certain levels will not be eligible (confirm with trial site)
• People who are willing to complete all required study procedures

Who may not be able to join:

• People who have any reactive or positive HIV test result at the enrolment visit, even if HIV infection has not been confirmed
• People who are currently taking part in another clinical trial involving PrEP, an HIV vaccine, or an experimental medication
• Transgender men who have a positive pregnancy test, are breastfeeding, or plan to become pregnant at enrolment
• People who have previously taken part in a study involving cabotegravir
• People who have a known allergy to any of the ingredients in the study medications
• People who have previously taken part in an HIV vaccine trial, unless they can provide documentation showing they received a placebo rather than the active vaccine
• People who plan to move away from the study area during the trial period
• People who have surgically placed or injected implants or fillers in the buttock area
• People who have a skin condition or inflammation over the buttock area that, in the study doctor's opinion, may affect how injection site reactions are assessed
• People who are currently using, or plan to use, certain medications that can reduce how well cabotegravir works in the body — these include some epilepsy medications (such as carbamazepine, oxcarbazepine, phenobarbital, and phenytoin) and some tuberculosis medications (such as rifampin and rifapentine)
• People who currently use or expect to need long-term blood-thinning medication, or who have a history of a bleeding disorder or prolonged bleeding
• People with a history of severe liver disease, including liver failure, hospitalisation for liver disease, liver cancer, or being close to needing a liver transplant
• People with advanced hepatitis C
• People with other medical conditions that, in the study doctor's opinion, would interfere with the study

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