A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tol… (NCT06970223) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
United States65 participantsStarted 2025-04-22
Plain-language summary
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. At the time of obtaining informed consent, 18 years of age.
✓. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive).
✓. Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring.
Exclusion criteria
✕. Male or female at birth (transgender individuals are not excluded but LEN may interfere with gender affirming hormones including increasing thrombotic risk. This should be discussed with Medical Monitor).
✕. All participants are expected to use barrier methods for HIV/STI prevention and should be counselled accordingly at all visits.
✕. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
✕. Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest-feeding, and at least 1 of the following conditions applies:
✕. A POCBP must have a negative highly sensitive pregnancy test (urine and/or serum as required) within the 21 days before the dose of study intervention.
✕0. Must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
✕. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. The investigator may contact the ViiV healthcare (VH) medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
What they're measuring
1
Percentage of participants reporting very acceptable or totally acceptable local reactions
Timeframe: 7 days after each injection (injections administered on Day 1 and Day 15)