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

A Phase 1 Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Switching to Cabotegravir Ultra Long-acting From Cabotegravir Long-acting in Healthy Adult Volunteers

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Drug: CAB LA; Drug: CAB ULA

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • GSK Investigational Site
  • Illinois
    • Oak Brook, Illinois, United States, 60532
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult participants greater than or equal to (>=) 18 years old, weighing at least 35 kg.
• Participants who are overtly healthy as determined by medical evaluation.
• Assigned male sex at birth or assigned female sex at birth. Participants assigned female sex at birth are eligible to participate if they are of non-childbearing potential, or if they are of childbearing potential and are not pregnant (confirmed by 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 of offering and administering CAB under the protocol at the site.
• Has the required qualifications according to their role and delegated the appropriate responsibilities by site Principal investigator (PI).
• Be able to understand and comply with protocol requirements, instructions, and restrictions.

Exclusion Criteria:

• Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, neurological, or psychiatric disorders capable of significantly altering drug pharmacokinetics, interfering with the participant's ability to comply with the dosing schedule and/or protocol evaluations, 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 epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• History of ongoing or clinically relevant seizure disorder within the previous 2 years.
• Participants who pose a significant suicidality risk.
• History or presence of sensitivity to any of the study medications, study procedure-related medications, their components or drugs of their class, or an allergy that contraindicates participation.
• Participant has an implant/enhancement (including fillers) at the area of proposed injection; or tattoo or other dermatological condition overlying any area which may significantly 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 exclusionary laboratory 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 with non-reactive results using appropriate HIV tests.
• Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
• Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
• Positive hepatitis C RNA test result at screening or within 3 months prior to first dose 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 investigational product was received within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.
• Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
• Positive pre-study drug/alcohol screen.
• History of or on-going high-risk behaviours that put the participant at increased risk for HIV infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAB Group; Participants will receive the CAB LA Q2M regimen up to Month 9 then will receive the CAB ULA Q4M regimen up to Month 23.	Drug: CAB LA; CAB LA injection will be administered; Drug: CAB ULA; CAB ULA injection will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma concentration of CAB at the end of the CAB LA phase compared to plasma concentration of CAB at the end of the CAB ULA phase	At Month 23 compared to Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of CAB at each assessment timepoint following CAB ULA injections		Up to Month 23
Number of participants with adverse events (AEs) (including Injection Site Reactions [ISRs]) as per severity	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.	Up to Month 32
Number of participants with laboratory abnormalities		Up to Month 32
Number of participants with changes in laboratory parameters over time		Up to Month 32
Number of participants with ISRs by grade	Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening	Up to Month 32
Duration (Days) of ISRs by grade	Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.	Up to Month 32

Collaborators and Investigators

• Sponsor: ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): November 8, 2027

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Tolerability; Healthy Adult; Cabotegravir (CAB); Ultra Long Acting (ULA); Long Acting (LA)
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections
• Other Study ID Numbers: 223369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No