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HIV InfectionsPhase 1NCT06786520

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 study testing CAB LA and CAB ULA in people with HIV Infections, run by ViiV Healthcare at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
CAB LA and CAB ULA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
3 sitesUnited States
Study dates
17 Jan 2025to 8 Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Oak Brook, Illinois, 60532

Other trials in United States

About this study

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

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.

Read the detailed description

The participants in the study will receive CAB LA in the CAB LA phase and CAB ULA in the CAB ULA phase.

Conditions
HIV Infections
Being tested
CAB LA, CAB ULA
Keywords
Cabotegravir (CAB), Ultra Long Acting (ULA), Long Acting (LA), Pharmacokinetics, Safety, Tolerability, Healthy Adult
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB LADrug

    CAB LA injection will be administered

  • CAB ULADrug

    CAB ULA injection will be administered

Study groups in NCT06786520
Study groupRoleWhat they receive
CAB GroupExperimentalParticipants will receive the CAB LA Q2M regimen up to Month 9 then will receive the CAB ULA Q4M regimen up to Month 23.
Receives: Drug: CAB LA; Drug: CAB ULA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At Month 23 compared to Month 9

Secondary outcomes (6)

  1. Plasma concentration of CAB at each assessment timepoint following CAB ULA injections

    Measured: Up to Month 23

  2. Number of participants with adverse events (AEs) (including Injection Site Reactions [ISRs]) as per severity

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.

    Measured: Up to Month 32

  3. Number of participants with laboratory abnormalities

    Measured: Up to Month 32

  4. Number of participants with changes in laboratory parameters over time

    Measured: Up to Month 32

  5. Number of participants with ISRs by grade

    Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening

    Measured: Up to Month 32

  6. Duration (Days) of ISRs by grade

    Severity of ISRs is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.

    Measured: Up to Month 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start17 Jan 2025
  3. Primary completion9 Mar 2027 (estimated)
  4. Study completion8 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06786520
Sponsor's protocol ID
223369
Status last verified
Jun 2025
First submitted
15 Jan 2025
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CAB LA and CAB ULA in people with HIV Infections, run by ViiV Healthcare at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: At Month 23 compared to Month 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06786520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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