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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
65
A single CAB LA injection administered intramuscularly.
Two LEN LA injections administered subcutaneously.
GSK Investigational Site
Long Beach, California, United States
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".
Time frame: 7 days after each injection (injections administered on Day 1 and Day 15)
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".
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
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.
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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
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.
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
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.
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
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.
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
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
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
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.
Time frame: 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).
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
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.
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
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.
Time frame: Up to 6 months post any injection compared to Baseline (Day 1)