Evaluating a new long-acting HIV treatment 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 tests a new long-acting HIV treatment to see if it is safe and works well for healthy adults who have already tried a different version of the treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ViiV Healthcare (Industry-sponsored)
• Locations: 3 sites (Mobile, Alabama and 2 other locations)
• Trial ID: NCT06786520 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics, safety, and tolerability of Cabotegravir Ultra Long-acting (CAB ULA) administered every four months after participants have received Cabotegravir Long-acting (CAB LA) every two months. Healthy adult volunteers will first receive CAB LA and then switch to CAB ULA to assess how well the body processes the new formulation. The study aims to determine if the longer dosing interval of CAB ULA is safe and well-tolerated compared to CAB LA.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 and older who meet specific health criteria and are capable of providing informed consent.

Not a fit: Patients who are not healthy or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more convenient long-term treatment option for HIV, reducing the frequency of dosing.

How similar studies have performed: Other studies have shown promise with long-acting formulations for HIV treatment, making this approach a continuation of successful strategies in the field.

Eligibility criteria

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.

Where this trial is running

Mobile, Alabama and 2 other locations

• GSK Investigational Site — Mobile, Alabama, United States (Recruiting)
• GSK Investigational Site — Coral Gables, Florida, United States (Recruiting)
• GSK Investigational Site — Oak Brook, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions HIV Infections; Cabotegravir; Ultra Long Acting; Long Acting; Pharmacokinetics; Safety; Tolerability; Healthy Adult