HIV Infections
Conditions
Keywords
Long-acting, Tolerability, Acceptability, Injection site reactions, Cabotegravir, Lenacapavir, Healthy adults
Brief 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.
Interventions
A single CAB LA injection administered intramuscularly.
Two LEN LA injections administered subcutaneously.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Masking description
Open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants are eligible to be included in the study only if all the following criteria apply: 1. At the time of obtaining informed consent, 18 years of age. 2. Body weight 50 kg and BMI within the range 18 to 32 kg/m2 (inclusive). 3. 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. 4. 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. 5. 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). 6. All participants are expected to use barrier methods for HIV/STI prevention and should be counselled accordingly at all visits. 7. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 8. 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. 9. 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. 10. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting very acceptable or totally acceptable local reactions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean injection site reaction scores, over time, post-injection, at days 8 and 22 | At Day 8 and Day 22 (7 days after each injection visit) | 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. |
| Median injection site reaction scores, over time, post-injection, at days 8 and 22 | At Day 8 and Day 22 (7 days after each injection visit) | 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. |
| Mean injection site reaction scores, over time, post-injection, at days 43 and 190 | At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection) | 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. |
| Median injection site reaction scores, over time, post-injection, at days 43 and 190 | At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection) | 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. |
| Change in the intensity of post-injection site pain assessed over time | At days 1, 2, 5 and 8 for the first injection and days 15, 16, 19, and 22 for the second injection | 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 |
| Percentage of participants with ISRs overall and by severity | Up to 6 months post any injection | 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. |
| Percentage of participants reporting very acceptable or totally acceptable local reactions at days 43 and 190 | At Day 43 (28 days after second injection) and Day 190 (26 weeks after second injection) | 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. |
| Mean duration of ISRs | Up to 6 months post any injection | — |
| Median duration of ISRs | Up to 6 months post any injection | — |
| Percentage of participants with adverse events (AEs) overall and by severity | Up to 6 months post a single dose of CAB LA and LEN LA sequentially administered | 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. |
| Number of participants with laboratory abnormalities | Up to 6 months post any injection | — |
| Number of participants with change in laboratory parameters over time | Up to 6 months post any injection compared to Baseline (Day 1) | — |
| Maximum change in toxicity grade from baseline in laboratory values | Up to 6 months post any injection compared to Baseline (Day 1) | 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. |
| Percentage of participants with specific ISRs of interest | Up to 6 months post any injection | 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). |
Countries
United States
Outcome results
None listed