ACTIVE_NOT_RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-17

Study Completion:2027-11-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06786520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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.

Contacts and Locations

Study Locations (Sites)

GSK Investigational Site

Mobile, Alabama, 36608

United States

GSK Investigational Site

Coral Gables, Florida, 33134

United States

GSK Investigational Site

Oak Brook, Illinois, 60532

United States

Collaborators and Investigators

Sponsor: ViiV Healthcare

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17

Study Completion Date2027-11-08

Study Record Updates

Study Start Date2025-01-17

Study Completion Date2027-11-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

HIV Infections