A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Cabotegravir Ultra Long-acting (CAB ULA) Following Switch From Cabotegravir Long-acting (CAB LA) in Healthy Adults

Last updated: February 17, 2025
Sponsor: ViiV Healthcare
Overall Status: Active - Recruiting

Phase

1

Condition

Hiv Infections

Treatment

CAB ULA

CAB LA

Clinical Study ID

NCT06786520
223369
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will assess the pharmacokinetics (PK), safety, and tolerability of CAB ULA administered every 4 months (Q4M) following administration of CAB LA every 2 months (Q2M), in healthy adult volunteers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants greater than or equal to (>=) 18 years old, weighing at least 35kg.

  • Participants who are overtly healthy as determined by medical evaluation.

  • Assigned male sex at birth or assigned female sex at birth. Participants assignedfemale sex at birth are eligible to participate if they are of non-childbearingpotential, or if they are of childbearing potential and are not pregnant (confirmedby test), not breastfeeding, and are using a highly effective contraceptive method.

  • Capable of giving written informed consent.

Healthcare staff will be eligible for inclusion in this study if:

  • They are site employees responsible for administrative or clinical aspects ofoffering and administering CAB under the protocol at the site.

  • Has the required qualifications according to their role and delegated theappropriate responsibilities by site Principal investigator (PI).

  • Be able to understand and comply with protocol requirements, instructions, andrestrictions.

Exclusion

Exclusion Criteria:

  • Presence or history of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, haematological, neurological, or psychiatric disorderscapable of significantly altering drug pharmacokinetics, interfering with theparticipant's ability to comply with the dosing schedule and/or protocolevaluations, or compromising participant safety.

  • Current or anticipated need for chronic anti-coagulants.

  • Any malignancy within the past 5 years except for basal cell or squamous epithelialcarcinomas of the skin that have been resected with no evidence of metastaticdisease for 3 years.

  • History of ongoing or clinically relevant seizure disorder within the previous 2years.

  • Participants who pose a significant suicidality risk.

  • History or presence of sensitivity to any of the study medications, studyprocedure-related medications, their components or drugs of their class, or anallergy that contraindicates participation.

  • Participant has an implant/enhancement (including fillers) at the area of proposedinjection; or tattoo or other dermatological condition overlying any area which maysignificantly interfere with interpretation of injection site reactions.

  • Inflammatory skin conditions that compromise the safety of injections.

  • Any acute laboratory abnormality that should preclude participation or exclusionarylaboratory value.

  • Human immunodeficiency virus (HIV-1 or HIV-2) infection.

  • Reactive or positive HIV test.

  • Signs and symptoms suggestive of acute HIV infection- that is not ruled out withnon-reactive results using appropriate HIV tests.

  • Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 monthsprior to first dose of study intervention.

  • Positive hepatitis C antibody test result at screening or within 3 months prior tofirst dose of study intervention.

  • Positive hepatitis C RNA test result at screening or within 3 months prior to firstdose of study intervention.

  • One or more exclusionary values for a screening ECG.

  • Participants receiving any protocol-prohibited medication.

  • Use of CAB LA for PrEP within 1 year.

  • Concurrent participation in another clinical study in which an investigationalproduct was received within 30 days, 5 half-lives or twice the duration of thebiological effect of the investigational product (whichever is longer).

  • Participation in the study would result in loss of blood or blood products in excessof 500 mL within 56 days.

  • Exposure to more than 4 new chemical entities within 12 months prior to the firstdosing day.

  • Positive pre-study drug/alcohol screen.

  • History of or on-going high-risk behaviours that put the participant at increasedrisk for HIV infection.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: CAB ULA
Phase: 1
Study Start date:
January 17, 2025
Estimated Completion Date:
February 29, 2028

Study Description

The participants in the study will receive CAB LA in the CAB LA phase and CAB ULA in the CAB ULA phase.

Connect with a study center

  • GSK Investigational Site

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • GSK Investigational Site

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • GSK Investigational Site

    Oak Brook, Illinois 60532
    United States

    Active - Recruiting

  • GSK Investigational Site

    Oakbrook, Illinois 60532
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.