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

NCT06786520 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 223369
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

HIV Infections

Keywords

Cabotegravir (CAB); Ultra Long Acting (ULA); Long Acting (LA); Pharmacokinetics; Safety; Tolerability; Healthy Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  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

  Up to Month 32

Study Arms (1)

CAB Group

EXPERIMENTAL

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; Drug: CAB ULA

Interventions

CAB LA DRUG

CAB LA injection will be administered

CAB Group

CAB ULA DRUG

CAB ULA injection will be administered

CAB Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Participants receiving any protocol-prohibited medication.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (3)

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Oak Brook, Illinois, 60532, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): March 9, 2027
• Study Completion (Estimated): November 8, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (3)