A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

Running, not enrolling · Phase 2

Conditions studied: HIV Infections

In brief

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.

Key facts

Study ID: NCT06741397
Run by: ViiV Healthcare
People needed: 229
Starts: 2024-12-20
Expected to finish: 2029-01-10
Last updated by the study team: 2025-11-18

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

At the time of obtaining informed consent, adolescent and adult participants weighing at least 35 kg.
Participants must have a nonreactive HIV test at Screening (rapid test, nonrapid HIV immunoassay, and HIV RNA) and enrollment (a rapid test, nonrapid HIV immunoassay, and HIV RNA).
Participants who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months.
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 at the time of screening.
No alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).
Participants who have received oral PrEP are eligible, but they must discontinue oral PrEP within 10 days of Day 1 visit.
Male or female at birth, (transgender individuals are not excluded). Contraceptive use should align with local regulations. Participants assigned female at birth must not be pregnant or breastfeeding and must either not be of childbearing potential (POCBP) or use highly effective contraception. A POCBP must have a negative pregnancy test within 30 days before dosing.
Participants must be >=16 years old, of legal age to consent to sexual intercourse, and capable of giving written informed consent. Adolescents must provide written informed assent/consent and/or obtain parental/guardian consent if not of legal age, as per site SOPs and IRB/EC policies.

You may not qualify if…

One or more reactive or positive HIV test results at Screening or Enrollment, even if HIV infection was not confirmed.
Participants who are breastfeeding or plan to become pregnant or breastfeed during the study.
Alanine aminotransferase (ALT) >=3 times the upper limit of normal (ULN).
Evidence of active Hepatitis B virus (HBV) infection.
Participants positive for HBsAg or HBV DNA are excluded.
Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
History of clinically relevant hepatitis within last 6 months.
Known history of liver cirrhosis with or without viral hepatitis co-infection.
Participants with Hepatitis C virus (HCV) co-infection will be allowed entry into this study if:
Liver enzymes meet entry criteria.
HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the primary endpoint (e.g., Month 13).
In the event that recent biopsy or imaging data is not available or inconclusive, the Fibrosis 4 (Fib-4) score will be used to verify eligibility:
i. Fib-4 score greater than (>) 3.25 is exclusionary. ii. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 score Formula: (Age x AST) / (Platelets x (sqr [ ALT]) It is approved by the Medical Monitor.
Estimated glomerular filtration rate of <30 mL/min/1.73 m\^2 via CKD-EPIcr_R (2021) method.
Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 [triglycerides or lipid abnormalities].
Participants determined by the Investigator to have a high risk of seizures, A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment.
Participant is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from the Medical Monitor is granted.
Presence of any history of allergy/sensitivity to any of the study drug.
Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator.
Participant has an implant/enhancement (including fillers) at the area of proposed injection (e.g., gluteus medius); or tattoo or other dermatological condition overlying the area for IM (e.g., gluteus medius) or any other area which may significantly interfere with interpretation of injection site reactions.
Current or anticipated need for chronic anti-coagulants or active coagulopathy (primary or iatrogenic) which would contraindicate IM injection.
Ongoing or clinically relevant pancreatitis.
Clinically significant cardiovascular disease or history of clinically significant cardiovascular disease.

Where it is running

GSK Investigational Site — Birmingham, Alabama, United States
GSK Investigational Site — Los Angeles, California, United States
GSK Investigational Site — Los Angeles, California, United States
GSK Investigational Site — Los Angeles, California, United States
GSK Investigational Site — Los Angeles, California, United States
GSK Investigational Site — Palm Springs, California, United States
GSK Investigational Site — Doral, Florida, United States
GSK Investigational Site — Ft. Pierce, Florida, United States
GSK Investigational Site — Orlando, Florida, United States
GSK Investigational Site — West Palm Beach, Florida, United States
GSK Investigational Site — Chicago, Illinois, United States
GSK Investigational Site — New Orleans, Louisiana, United States
GSK Investigational Site — Springfield, Massachusetts, United States
GSK Investigational Site — Berkley, Michigan, United States
GSK Investigational Site — Kansas City, Missouri, United States
GSK Investigational Site — Las Vegas, Nevada, United States
GSK Investigational Site — New York, New York, United States
GSK Investigational Site — Valhalla, New York, United States
GSK Investigational Site — Greensboro, North Carolina, United States
GSK Investigational Site — Cincinnati, Ohio, United States
GSK Investigational Site — Columbus, Ohio, United States
GSK Investigational Site — Pittsburgh, Pennsylvania, United States
GSK Investigational Site — Dallas, Texas, United States
GSK Investigational Site — Fort Worth, Texas, United States
GSK Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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