HIV InfectionsPhase 1NCT06970223
A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV
A Phase 1 study testing Cabotegravir long-acting and Lenacapavir long-acting in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes. 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?
- Cabotegravir long-acting and Lenacapavir long-acting
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 10 Jul 2026
- 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
- Participants are eligible to be included in the study only if all the following criteria apply:
- At the time of obtaining informed consent, 18 years of age.
- Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive).
- Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring.
- A participant with a significant clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility.
- Male or female at birth (transgender individuals are not excluded but LEN may interfere with gender affirming hormones including increasing thrombotic risk. This should be discussed with Medical Monitor).
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- All participants are expected to use barrier methods for HIV/STI prevention and should be counselled accordingly at all visits.
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Participants assigned female at birth are eligible to participate if they are not pregnant or breast/chest-feeding, and at least 1 of the following conditions applies:
- Is not a person of childbearing potential (POCBP) OR
- Is a POCBP and using a contraceptive method that is highly effective, with a failure rate of <1%. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- A POCBP must have a negative highly sensitive pregnancy test (urine and/or serum as required) within the 21 days before the dose of study intervention.
- Must be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. The investigator may contact the ViiV healthcare (VH) medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
- Suspected or known active, serious infection(s).
- Abnormal blood pressure as determined by the investigator.
- History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which is considered cured with minimal risk of recurrence. Participants under evaluation for possible malignancy are not eligible.
- Breast cancer within the past 10 years
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- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The participant has an underlying skin disease or disorder (i.e., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that would interfere with assessment of injection sites.
- Current or anticipated need for chronic anti-coagulation.
- Participants considered to have insufficient musculature to allow safe intramuscular (e.g., gluteus medius, vastus lateralis) or sufficient subcutaneous thickness to allow subcutaneous administration in the opinion of the investigator.
- Any Positive Treponeme Specific Serologic testing (positive T. Pallidum antibody immunoassay + Rapid plasma reagin [RPR] or positive T. Pallidum antibody immunoassay + Treponema pallidum particle agglutination [TPPA]) is exclusionary.
- Presence of HBsAg, or positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study treatment.
- Have a history of osteoporosis or bone fragility fractures.
- Participants who, in the investigator's judgment, poses a significant suicidality risk. Participant's history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.
- Any preexisting physical or mental condition which, in the opinion of the Investigator or the Medical Monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
- Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
- Treatment with any of the following agents within 60 days of screening: radiation therapy, cytotoxic chemotherapeutic agents, any systemic immune suppressant.
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing.
- Use of glucocorticoids (through any route).
- Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.
- Current enrolment or past participation in another investigational study in which an investigational intervention (e.g., drug, human blood product, monoclonal antibody, vaccine, invasive device) was administered within 1 month, 5 half-lives or twice the duration of the biological effect of the test agent prior to screening (whichever is longer).
- Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
- Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 triglycerides or lipid abnormalities. A single repeat test is allowed during the screening period to verify a result.
- ALT greater than or equal to (>=) 1.5x ULN. A single repeat test is allowed within a single Screening period to determine eligibility.
- Total bilirubin >=1.5x ULN (isolated total bilirubin greater than [>] 1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than [<] 35%). A single repeat test is allowed within a single screening period to determine eligibility.
- Creatinine clearance (eGFR) of <60 mL/min/1.73 m2 via CKD-EPI method.
- Positive HIV antibody/antigen test (HIV-1, HIV-2) at screening or enrolment. Participants will be advised regarding safer sex. In the event a participant acquires HIV during the study they will be required to withdraw from the study and will be referred urgently to an HIV treatment center for further management.
- Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting surgery or percutaneous transluminal coronary angioplasty or any clinically significant cardiac disease.
- Grade 3 or Grade 4 proteinuria or glycosuria at screening that is unexplained or not clinically manageable.
- Participant is unlikely to adhere to the study procedures, keep appointments, is planning to relocate during the study, or remain on study through to its conclusion.
- Alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).
- Participant has an implant/enhancement (including fillers) at the area of proposed injection; or tattoo or other dermatological condition overlying the area for IM or SC injection (e.g., gluteus medius, vastus lateralis or anterior abdominal wall) or any other area which may significantly interfere with interpretation of injection site reactions.
Trial locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Long Beach, California, 90815
About this study
Official title: Phase 1, Open-Label, Randomised Crossover Study Assessing the Tolerability and Acceptability of Long Acting Cabotegravir Intramuscular and Lenacapavir Subcutaneous Injections Over Time in Healthy Adults Without HIV
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
- Conditions
- HIV Infections
- Being tested
- Cabotegravir long-acting, Lenacapavir long-acting
- Keywords
- Long-acting, Tolerability, Acceptability, Injection site reactions, Cabotegravir, Lenacapavir, Healthy adults
- Medical subject headings
- HIV Infections, Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir long-actingDrug
Also called Cabotegravir
A single CAB LA injection administered intramuscularly.
Lenacapavir long-actingDrug
Two LEN LA injections administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| CAB LA/LEN LA Group | Experimental | Participants receive the CAB LA injection at Day 1 followed by the LEN LA injections at Day 15. Receives: Drug: Cabotegravir long-acting; Drug: Lenacapavir long-acting |
| LEN LA/CAB LA Group | Experimental | Participants receive the LEN LA injections at Day 1 followed by the CAB LA injection at Day 15. Receives: Drug: Cabotegravir long-acting; Drug: Lenacapavir long-acting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting very acceptable or totally acceptable local reactions
The analysis is performed using the 21-item perception of injection (PIN) questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain.
"Acceptance of ISR" is reported in this outcome measure for 2 scores: "very acceptable ISR: and "totally acceptable ISR".
Measured: 7 days after each injection (injections administered on Day 1 and Day 15)
Secondary outcomes (14)
Percentage of participants reporting very acceptable or totally acceptable local reactions at days 43 and 190
The analysis is performed using the 21-item PIN questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain.
"Acceptance of ISR" is reported in this outcome measure for 2 scores: "very acceptable ISR: and "totally acceptable ISR".
Measured: At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)
Mean injection site reaction scores, over time, post-injection, at days 8 and 22
The analysis is performed using the 21-item PIN questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain.
Measured: At Day 8 and Day 22 (7 days after each injection visit)
Median injection site reaction scores, over time, post-injection, at days 8 and 22
The analysis is performed using the 21-item PIN questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain.
Measured: At Day 8 and Day 22 (7 days after each injection visit)
Mean injection site reaction scores, over time, post-injection, at days 43 and 190
The analysis is performed using the 21-item PIN questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain.
Measured: At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)
Median injection site reaction scores, over time, post-injection, at days 43 and 190
The analysis is performed using the 21-item PIN questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain.
Measured: At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)
Change in the intensity of post-injection site pain assessed over time
The analysis is performed using the numerical rating scale (NRS), which is a visual analogue scale that assesses the maximum level of pain experienced with injections ranging from 0 (no pain) to 10 (extreme pain). An NRS related to each injection is self-administered electronically at the clinic visits at the same timepoints after each injection
Measured: At days 1, 2, 5 and 8 for the first injection and days 15, 16, 19, and 22 for the second injection
Percentage of participants with ISRs overall and by severity
The ISRs severity is graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
Measured: Up to 6 months post any injection
Percentage of participants with specific ISRs of interest
The ISRs of interest are nodules (maximum diameter and visibility over time), pigmentation changes (assessed surface area, distinction of hyperpigmentation vs hypopigmentation), and induration/ swelling (visibility over time).
Measured: Up to 6 months post any injection
Mean duration of ISRs
Measured: Up to 6 months post any injection
Median duration of ISRs
Measured: Up to 6 months post any injection
Percentage of participants with adverse events (AEs) overall and by 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. The AEs severity is graded using the DAIDS criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
Measured: Up to 6 months post a single dose of CAB LA and LEN LA sequentially administered
Number of participants with laboratory abnormalities
Measured: Up to 6 months post any injection
Number of participants with change in laboratory parameters over time
Measured: Up to 6 months post any injection compared to Baseline (Day 1)
Maximum change in toxicity grade from baseline in laboratory values
Toxicity is graded using the DAIDS criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening. A higher grade indicates greater severity.
Measured: Up to 6 months post any injection compared to Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start22 Apr 2025
- Primary completion15 Jul 2025
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970223
- Sponsor's protocol ID
- 223616
- Status last verified
- Nov 2025
- First submitted
- 11 Apr 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomised Crossover Study Assessing the Tolerability and Acceptability of Long Acting Cabotegravir Intramuscular and Lenacapavir Subcutaneous Injections Over Time in Healthy Adults Without HIV
- ClinicalTrials.gov ID
- NCT06970223
- Acronym / sponsor ID
- 223616
- Conditions
- HIV Infections
- Keywords
- Long-acting, Tolerability, Acceptability, Injection site reactions, Cabotegravir, Lenacapavir, Healthy adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAB LA/LEN LA Group | Experimental | Drug: Cabotegravir long-acting, Drug: Lenacapavir long-actingParticipants receive the CAB LA injection at Day 1 followed by the LEN LA injections at Day 15. |
| LEN LA/CAB LA Group | Experimental | Drug: Cabotegravir long-acting, Drug: Lenacapavir long-actingParticipants receive the LEN LA injections at Day 1 followed by the CAB LA injection at Day 15. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants are eligible to be included in the study only if all the following criteria apply:
- At the time of obtaining informed consent, 18 years of age.
- Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive).
- Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring.
- A participant with a significant clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included if the investigator determines and documents that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility.
Key exclusion criteria (32 listed)
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. The investigator may contact the ViiV healthcare (VH) medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
- Suspected or known active, serious infection(s).
- Abnormal blood pressure as determined by the investigator.
- History of any malignancy within the past 5 years. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which is considered cured with minimal risk of recurrence. Participants under evaluation for possible malignancy are not eligible.
- Breast cancer within the past 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir long-actingAlso: CabotegravirA single CAB LA injection administered intramuscularly. | Drug | CAB LA/LEN LA Group, LEN LA/CAB LA Group |
| Lenacapavir long-actingTwo LEN LA injections administered subcutaneously. | Drug | CAB LA/LEN LA Group, LEN LA/CAB LA Group |
Primary outcome
Percentage of participants reporting very acceptable or totally acceptable local reactions
Time frame: 7 days after each injection (injections administered on Day 1 and Day 15)
The analysis is performed using the 21-item perception of injection (PIN) questionnaire which includes 21 items grouped into 4 multi-item domains: 'Acceptance of ISR' scale score (2 items); 'Bother from ISR' scale score (6 items); 'Leg movement' scale score (4 items); 'Sleep' scale score (4 items); and 5 standalone items: pain during injection; anxiety before injection; anxiety after injection; willingness to be injected in the future; and overall satisfaction with mode of administration. Participant responses are scored on a 5-point Likert scale, where 1 represents the least favorable perception of injection and 5 the most favorable, with domain scores calculated as the mean of all items in that domain. "Acceptance of ISR" is reported in this outcome measure for 2 scores: "very acceptable ISR: and "totally acceptable ISR".
14 secondary outcomes
Percentage of participants reporting very acceptable or totally acceptable local reactions at days 43 and 190
Time frame: At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)
Mean injection site reaction scores, over time, post-injection, at days 8 and 22
Time frame: At Day 8 and Day 22 (7 days after each injection visit)
Median injection site reaction scores, over time, post-injection, at days 8 and 22
Time frame: At Day 8 and Day 22 (7 days after each injection visit)
Mean injection site reaction scores, over time, post-injection, at days 43 and 190
Time frame: At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)
Median injection site reaction scores, over time, post-injection, at days 43 and 190
Time frame: At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection)
Change in the intensity of post-injection site pain assessed over time
Time frame: At days 1, 2, 5 and 8 for the first injection and days 15, 16, 19, and 22 for the second injection
Percentage of participants with ISRs overall and by severity
Time frame: Up to 6 months post any injection
Percentage of participants with specific ISRs of interest
Time frame: Up to 6 months post any injection
Mean duration of ISRs
Time frame: Up to 6 months post any injection
Median duration of ISRs
Time frame: Up to 6 months post any injection
Percentage of participants with adverse events (AEs) overall and by severity
Time frame: Up to 6 months post a single dose of CAB LA and LEN LA sequentially administered
Number of participants with laboratory abnormalities
Time frame: Up to 6 months post any injection
Number of participants with change in laboratory parameters over time
Time frame: Up to 6 months post any injection compared to Baseline (Day 1)
Maximum change in toxicity grade from baseline in laboratory values
Time frame: Up to 6 months post any injection compared to Baseline (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cabotegravir long-acting and Lenacapavir long-acting in people with HIV Infections, run by ViiV Healthcare at 1 site 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 13 inclusion and 32 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Percentage of participants reporting very acceptable or totally acceptable local reactions (time frame: 7 days after each injection (injections administered on Day 1 and Day 15)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.