Phase 1 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 aged 19 years or older
• People using hormone treatments who have been on a stable, doctor-managed hormone regimen for at least 6 months and are able to continue that same regimen throughout the study
• Females who are using a non-hormonal form of contraception and are willing to continue using it for the entire duration of the study
• People who weigh more than 35 kg (77.2 lbs)
• People who do not have HIV at the time of screening and enrollment, confirmed by blood testing
• People who understand and agree to local requirements for reporting sexually transmitted infections (STIs)
• People willing to avoid all other HIV prevention or treatment medications (including PrEP medications F/TAF and F/TDF) for the entire study period
• People willing to avoid inserting anything (including medications, enemas, sex toys, or engaging in anal or vaginal sex) for 72 hours before and after each internal examination procedure called a flexible sigmoidoscopy
• People willing to avoid aspirin and anti-inflammatory pain medications (such as ibuprofen) for one week before and after each study visit involving a tissue sample (biopsy)
• People willing to use condoms for all receptive anal and vaginal sex for the entire duration of the study
• People who are able and willing to communicate in English
• People who are able and willing to sign a written consent form agreeing to take part
• People who are able to provide enough contact and location information for study follow-up purposes
• People who are available to attend all required study visits, unless unexpected circumstances arise
• People who agree not to join other research studies involving drugs or medical devices while this study is ongoing

Who may not be able to join:

• People who have previously used long-acting antiretroviral medications, including cabotegravir long-acting (CAB-LA) or long-acting lenacapavir
• People who have used oral PrEP medications (F/TDF or F/TAF) within the past eight weeks
• Females who are currently pregnant or plan to become pregnant during the study
• Females who are currently breastfeeding
• Females who have gone through menopause or whose hormone replacement therapy is managed externally (confirm with trial site)
• Females who have irregular menstrual cycles
• People who have a tattoo or skin condition in the area where the study injection would be given, which may interfere with administering the product or assessing injection site reactions
• People who have surgically placed or injected implants or fillers in the buttocks area
• People who had any reactive or positive HIV test result at screening or enrollment, even if a full HIV diagnosis was not confirmed
• People who currently have a known HIV-positive sexual partner
• People who are showing symptoms that may suggest they are in the early stages of HIV infection at the time of screening or enrollment
• People with a known or suspected allergy to CAB-LA
• People who have certain abnormal laboratory (blood or other test) results at the start of the study, at a level defined as Grade 2 or higher by a standard medical grading scale (confirm with trial site)
• People who have significant rectal symptoms or conditions, including unhealed injuries, active infection or inflammation in that area, inflammatory bowel disease, symptomatic haemorrhoids, or painful conditions in the anal or rectal area
• People who, within the past 2 months, have had symptoms or a confirmed diagnosis of an active rectal or genital infection that requires treatment — including chlamydia, gonorrhoea, syphilis, active herpes lesions, chancroid, genital sores or ulcers, or genital warts — or a symptomatic urinary tract infection (note: having a positive herpes blood test without active sores is not an automatic exclusion; and people found to have a treatable STI other than HIV may be able to rescreen after treatment)
• People with a history of significant gastrointestinal (digestive tract) bleeding
• People with a clinically significant heart condition, including a history of irregular heartbeat with symptoms, reduced blood flow to the heart, or other serious cardiac disease
• People currently taking blood-thinning medications such as warfarin, heparin, or other anticoagulants, or who regularly take high-dose aspirin (more than 81 mg daily), anti-inflammatory pain medications, or the blood thinner Pradaxa®
• People who have used immune-modifying medications (taken by mouth or applied to the rectal area) within 4 weeks before joining the study, or who plan to use them at any point during the study
• People who have used products applied rectally or vaginally that contain the ingredient N-9, or any experimental products, within 4 weeks before joining the study, or who plan to use them during the study
• People with any other health condition or prior treatment that, in the opinion of the study doctor, would make participation unsafe, unsuitable, or difficult to complete
• People with a neocervix will not be asked to provide cervical tissue samples, even if otherwise eligible to participate (confirm with trial site)

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