Who is eligible for clinical trial NCT06786520?

Participants must meet the protocol's inclusion criteria for HIV Infections. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06786520 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-06-16

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)

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

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: ViiV Healthcare

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (24 items).

Location: GSK Investigational Site — Mobile, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

GSK Investigational Site — Mobile, Alabama
GSK Investigational Site — Coral Gables, Florida
GSK Investigational Site — Oak Brook, Illinois

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All HIV Infections clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗