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NCT06786520Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 19 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
69 (actual)
First submitted
15 Jan 2025
Start date
17 Jan 2025
Primary completion date
9 Mar 2027
Lead sponsor
ViiV Healthcare
Diseases
HIV
NCT number
NCT06786520

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 69
  • From 17 Jan 2025 to the primary completion date, 9 Mar 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of ongoing or clinically relevant seizure disorder within the previous 2 years.
  • 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.
  • 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).
  • Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
  • Positive pre-study drug/alcohol screen.

Other illness

  • 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.
  • 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 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.
  • History of or on-going high-risk behaviours that put the participant at increased risk for HIV infection.

Lab values

  • Any acute laboratory abnormality that should preclude participation or exclusionary laboratory value.

Other

  • Current or anticipated need for chronic anti-coagulants.
  • Participants who pose a significant suicidality risk.
  • One or more exclusionary values for a screening ECG.
  • Use of CAB LA for PrEP within 1 year.
  • Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
Coral GablesUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
MobileUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
Oak BrookUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.