Trial Outcomes & Findings for Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study (NCT NCT05896748)
NCT ID: NCT05896748
Last Updated: 2024-11-26
Results Overview
Blood samples were collected at indicated time points for PK analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
94 participants
Primary outcome timeframe
At screening Week-4; Day 1, Week 4, Week 8 for SC injections; and Week 12 for Return to IM gluteal injection
Results posted on
2024-11-26
Participant Flow
The sub-study Safety population, which included all enrolled participants who received at least 1 subcutaneous (SC) injection, was used to present the baseline characteristics and outcome measures. Participant flow was presented for the overall group, adverse events were presented phase wise and outcome measures were presented for the overall group or treatment wise (per dose or per overall treatment received).
Participant milestones
| Measure |
Cabotegravir Long Acting (CAB LA) 400 Milligrams (mg) + Rilpivirine Long Acting (RPV) LA 600 mg
Participants received an intramuscular (IM) injection of CAB LA 400 mg and RPV LA 600 mg on week -4 during the Screening phase. Participants then received a sub-cutaneous (SC) injection of CAB LA 400 mg + RPV LA 600 mg on Day 1 of Week 1, Week 4 and Week 8 (once in every 4 weeks (Q4W)) for a total of 12 weeks during the SC abdominal Injection Phase. 4 weeks later, participants returned to the clinic for an IM gluteal injection (at Week 12) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W at Week 16.
|
|---|---|
|
Screening Phase (Week -4 up to Day 1)
STARTED
|
94
|
|
Screening Phase (Week -4 up to Day 1)
COMPLETED
|
93
|
|
Screening Phase (Week -4 up to Day 1)
NOT COMPLETED
|
1
|
|
SC Injection Phase (Day 1 up to Week 12)
STARTED
|
93
|
|
SC Injection Phase (Day 1 up to Week 12)
COMPLETED
|
87
|
|
SC Injection Phase (Day 1 up to Week 12)
NOT COMPLETED
|
6
|
|
Return to IM Glu Inj Phase(Week12-Week20
STARTED
|
87
|
|
Return to IM Glu Inj Phase(Week12-Week20
COMPLETED
|
86
|
|
Return to IM Glu Inj Phase(Week12-Week20
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Cabotegravir Long Acting (CAB LA) 400 Milligrams (mg) + Rilpivirine Long Acting (RPV) LA 600 mg
Participants received an intramuscular (IM) injection of CAB LA 400 mg and RPV LA 600 mg on week -4 during the Screening phase. Participants then received a sub-cutaneous (SC) injection of CAB LA 400 mg + RPV LA 600 mg on Day 1 of Week 1, Week 4 and Week 8 (once in every 4 weeks (Q4W)) for a total of 12 weeks during the SC abdominal Injection Phase. 4 weeks later, participants returned to the clinic for an IM gluteal injection (at Week 12) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W at Week 16.
|
|---|---|
|
Screening Phase (Week -4 up to Day 1)
Passed away due to unknown reasons
|
1
|
|
SC Injection Phase (Day 1 up to Week 12)
Adverse Event
|
2
|
|
SC Injection Phase (Day 1 up to Week 12)
Protocol Violation
|
1
|
|
SC Injection Phase (Day 1 up to Week 12)
Withdrawal by Subject
|
3
|
|
Return to IM Glu Inj Phase(Week12-Week20
Protocol Violation
|
1
|
Baseline Characteristics
Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study
Baseline characteristics by cohort
| Measure |
Cabotegravir Long Acting (CAB LA) 400 Milligrams (mg) + Rilpivirine Long Acting (RPV) LA 600 mg
n=93 Participants
Participants received an intramuscular (IM) injection of CAB LA 400 mg and RPV LA 600 mg on week -4 during the Screening phase. Participants then received a sub-cutaneous (SC) injection of CAB LA 400 mg + RPV LA 600 mg on Day 1 of Week 1, Week 4 and Week 8 (once in every 4 weeks (Q4W)) for a total of 12 weeks during the SC abdominal Injection Phase. 4 weeks later, participants returned to the clinic for an IM gluteal injection (at Week 12) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W at Week 16.
|
|---|---|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
63 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
De-identified
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At screening Week-4; Day 1, Week 4, Week 8 for SC injections; and Week 12 for Return to IM gluteal injectionPopulation: Analysis was performed on sub-study Pharmacokinetic (PK) parameter set for CAB LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Ctau parameter estimated during the sub-study period.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=81 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=74 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
n=84 Participants
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
n=78 Participants
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
n=85 Participants
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA
|
2.759 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 36.64
|
2.670 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 37.02
|
2.607 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 39.00
|
2.632 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 38.87
|
2.797 microgram per milliliter (µg/mL)
Geometric Coefficient of Variation 36.18
|
PRIMARY outcome
Timeframe: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injectionPopulation: Analysis was performed on sub-study PK parameter set for RPV LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Ctau parameter estimated during the sub-study period.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=80 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=75 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
n=84 Participants
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
n=77 Participants
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
n=84 Participants
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA
|
137.021 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38.51
|
138.611 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.43
|
135.620 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.55
|
128.590 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39.71
|
139.879 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43.06
|
PRIMARY outcome
Timeframe: At screening week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injectionPopulation: Analysis was performed on sub-study PK parameter set for CAB LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Cmax parameter estimated during the sub-study period.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=90 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=92 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
n=89 Participants
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
n=86 Participants
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
n=85 Participants
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA
|
3.545 µg/mL
Geometric Coefficient of Variation 34.77
|
3.316 µg/mL
Geometric Coefficient of Variation 35.22
|
3.165 µg/mL
Geometric Coefficient of Variation 36.77
|
3.215 µg/mL
Geometric Coefficient of Variation 34.56
|
3.529 µg/mL
Geometric Coefficient of Variation 37.05
|
PRIMARY outcome
Timeframe: At screening Week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injectionPopulation: Analysis was performed on sub-study PK parameter set for RPV LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Cmax parameter estimated during the sub-study period.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=89 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=92 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
n=89 Participants
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
n=86 Participants
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
n=84 Participants
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA
|
162.287 ng/mL
Geometric Coefficient of Variation 35.73
|
152.614 ng/mL
Geometric Coefficient of Variation 36.56
|
148.051 ng/mL
Geometric Coefficient of Variation 35.27
|
149.145 ng/mL
Geometric Coefficient of Variation 36.91
|
154.659 ng/mL
Geometric Coefficient of Variation 36.38
|
PRIMARY outcome
Timeframe: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12, for Return to IM gluteal injectionPopulation: Analysis was performed on sub-study PK parameter set for CAB LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable AUC\[0-tau\] parameter estimated during the sub-study period.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=80 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=73 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
n=82 Participants
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
n=78 Participants
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
n=85 Participants
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA
|
2051.172 hour microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 34.31
|
1997.801 hour microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 33.94
|
1943.596 hour microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 35.25
|
1943.787 hour microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 35.53
|
2155.520 hour microgram per milliliter (h*µg/mL)
Geometric Coefficient of Variation 32.71
|
PRIMARY outcome
Timeframe: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injectionPopulation: Analysis was performed on sub-study PK parameter set for RPV LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable AUC\[0-tau\] parameter estimated during the sub-study period.
Blood samples were collected at indicated time points for PK analysis.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=78 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=73 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
n=83 Participants
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
n=77 Participants
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
n=83 Participants
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA
|
98003.488 h*µg/mL
Geometric Coefficient of Variation 34.31
|
98801.696 h*µg/mL
Geometric Coefficient of Variation 35.32
|
95743.414 h*µg/mL
Geometric Coefficient of Variation 34.56
|
93248.069 h*µg/mL
Geometric Coefficient of Variation 34.85
|
100006.767 h*µg/mL
Geometric Coefficient of Variation 34.78
|
SECONDARY outcome
Timeframe: From Day 1 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
Severity of ISRs was analyzed using division of acquired immunodeficiency syndrome (DAIDS) grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase
Severe or Grade 3 ISRs
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase
ISRs
|
85 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase
Mild or Grade 1 ISRs
|
43 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase
Moderate or Grade 2 ISRs
|
36 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase
Potentially Life-Threatening or Grade 4 ISRs
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase
Death or Grade 5 ISRs
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AESI was analyzed using DAIDS grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. AESI assessed were Depression, Anxiety, Impact on creatinine, Hyperglycaemia.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Mild or Grade 1 Anxiety
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Moderate or Grade 2 Anxiety
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Severe or Grade 3 Anxiety
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Potentially Life-Threatening or Grade 4 Anxiety
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Death or Grade 5 Anxiety
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Any Impact on Creatinine
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Mild or Grade 1 Impact on Creatinine
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Moderate or Grade 2 Impact on Creatinine
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Severe or Grade 3 Impact on Creatinine
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Potentially Life-Threatening or Grade 4 Impact on Creatinine
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Death or Grade 5 Impact on Creatinine
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Any Hyperglycaemia
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Mild or Grade 1 Hyperglycaemia
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Moderate or Grade 2 Hyperglycaemia
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Severe or Grade 3 Hyperglycaemia
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Potentially Life-Threatening or Grade 4 Hyperglycaemia
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Death or Grade 5 Hyperglycaemia
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Any Depression
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Mild or Grade 1 Depression
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Moderate or Grade 2 Depression
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Severe or Grade 3 Depression
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Potentially Life-Threatening or Grade 4 Depression
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Death or Grade 5 Depression
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase
Any Anxiety
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase
Discontinuations due to ISR
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase
Discontinuations due to AESI
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week -4 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase
Any AEs
|
90 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase
Any SAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected as assessed by protocol, at specific time points for the analysis of clinical chemistry parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALT, Baseline (screening Week -4)
|
21.6 International units per liter (IU/L)
Standard Deviation 10.38
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALT, CFB at Week 4
|
1.2 International units per liter (IU/L)
Standard Deviation 8.09
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALT, CFB at Week 8
|
-0.4 International units per liter (IU/L)
Standard Deviation 5.94
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALT, CFB at Week 12
|
-0.7 International units per liter (IU/L)
Standard Deviation 7.32
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALP, Baseline (screening Week -4)
|
62.3 International units per liter (IU/L)
Standard Deviation 14.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALP, CFB at Week 4
|
-0.1 International units per liter (IU/L)
Standard Deviation 7.51
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALP, CFB at Week 8
|
0.7 International units per liter (IU/L)
Standard Deviation 6.66
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
ALP, CFB at Week 12
|
-0.4 International units per liter (IU/L)
Standard Deviation 6.29
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
AST, Baseline (screening Week -4)
|
20.1 International units per liter (IU/L)
Standard Deviation 6.27
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
AST, CFB at Week 4
|
2.2 International units per liter (IU/L)
Standard Deviation 12.33
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
AST, CFB at Week 8
|
0.1 International units per liter (IU/L)
Standard Deviation 5.52
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
AST, CFB at Week 12
|
-0.2 International units per liter (IU/L)
Standard Deviation 5.46
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
Creatine phosphokinase, Baseline (screening Week -4)
|
166.8 International units per liter (IU/L)
Standard Deviation 163.38
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
Creatine phosphokinase, CFB at Week 4
|
47.7 International units per liter (IU/L)
Standard Deviation 340.57
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
Creatine phosphokinase, CFB at Week 8
|
3.3 International units per liter (IU/L)
Standard Deviation 206.30
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
Creatine phosphokinase, CFB at Week 12
|
-0.9 International units per liter (IU/L)
Standard Deviation 162.90
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Creatinine, Baseline (screening Week -4)
|
86.23 Micromoles per liter (umol/L)
Standard Deviation 14.551
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Creatinine, CFB at Week 4
|
-1.84 Micromoles per liter (umol/L)
Standard Deviation 5.811
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Creatinine, CFB at Week 8
|
-1.55 Micromoles per liter (umol/L)
Standard Deviation 8.224
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Creatinine, CFB at Week 12
|
-0.35 Micromoles per liter (umol/L)
Standard Deviation 7.206
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Total Bilirubin, Baseline (screening Week -4)
|
9.2 Micromoles per liter (umol/L)
Standard Deviation 4.01
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Total Bilirubin, CFB at Week 4
|
0.5 Micromoles per liter (umol/L)
Standard Deviation 3.52
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Total Bilirubin, CFB at Week 8
|
-0.5 Micromoles per liter (umol/L)
Standard Deviation 3.64
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Total Bilirubin, CFB at Week 12
|
-1.2 Micromoles per liter (umol/L)
Standard Deviation 3.21
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Phosphate, CFB at Week 4
|
-0.002 Millimoles per liter (mmol/L)
Standard Deviation 0.1836
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Glucose, Baseline (screening Week -4)
|
5.14 Millimoles per liter (mmol/L)
Standard Deviation 0.808
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Glucose, CFB at Week 12
|
-0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.571
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Potassium, Baseline (screening Week -4)
|
4.19 Millimoles per liter (mmol/L)
Standard Deviation 0.304
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Potassium, CFB at Week 4
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.389
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Potassium, CFB at Week 8
|
0.03 Millimoles per liter (mmol/L)
Standard Deviation 0.307
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Potassium, CFB at Week 12
|
-0.04 Millimoles per liter (mmol/L)
Standard Deviation 0.346
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Sodium, Baseline (screening Week -4)
|
139.8 Millimoles per liter (mmol/L)
Standard Deviation 1.81
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Sodium, CFB at Week 4
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 1.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Sodium, CFB at Week 8
|
0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.11
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Sodium, CFB at Week 12
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 1.91
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Blood Urea Nitrogen, Baseline (screening Week -4)
|
5.33 Millimoles per liter (mmol/L)
Standard Deviation 1.639
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Blood Urea Nitrogen, CFB at Week 4
|
0.13 Millimoles per liter (mmol/L)
Standard Deviation 1.206
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Blood Urea Nitrogen, CFB at Week 8
|
0.22 Millimoles per liter (mmol/L)
Standard Deviation 1.417
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Blood Urea Nitrogen, CFB at Week 12
|
-0.04 Millimoles per liter (mmol/L)
Standard Deviation 1.368
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Carbon Dioxide, Baseline (screening Week -4)
|
23.6 Millimoles per liter (mmol/L)
Standard Deviation 2.04
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Carbon Dioxide, CFB at Week 4
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.09
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Carbon Dioxide, CFB at Week 8
|
-0.6 Millimoles per liter (mmol/L)
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Carbon Dioxide, CFB at Week 12
|
-0.5 Millimoles per liter (mmol/L)
Standard Deviation 1.83
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Chloride, Baseline (screening Week -4)
|
103.7 Millimoles per liter (mmol/L)
Standard Deviation 2.15
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Chloride, CFB at Week 4
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.55
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Chloride, CFB at Week 8
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.36
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Chloride, CFB at Week 12
|
0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.38
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Phosphate, Baseline (screening Week -4)
|
1.103 Millimoles per liter (mmol/L)
Standard Deviation 0.1651
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Phosphate, CFB at Week 8
|
0.023 Millimoles per liter (mmol/L)
Standard Deviation 0.1731
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Phosphate, CFB at Week 12
|
-0.015 Millimoles per liter (mmol/L)
Standard Deviation 0.1570
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin
Baseline (screening Week -4)
|
43.1 Grams per liter (g/L)
Standard Deviation 2.66
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin
CFB at Week 4
|
0.4 Grams per liter (g/L)
Standard Deviation 2.56
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin
CFB at Week 8
|
0.8 Grams per liter (g/L)
Standard Deviation 2.20
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin
CFB at Week 12
|
-0.1 Grams per liter (g/L)
Standard Deviation 2.11
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase
Baseline (screening Week -4)
|
29.4 Units per liter (U/L)
Standard Deviation 17.69
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase
CFB at Week 4
|
0.3 Units per liter (U/L)
Standard Deviation 10.97
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase
CFB at Week 8
|
5.6 Units per liter (U/L)
Standard Deviation 25.61
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase
CFB at Week 12
|
1.4 Units per liter (U/L)
Standard Deviation 11.66
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance
Baseline (screening Week -4)
|
93.9 Milliliter per minute (mL/min)
Standard Deviation 15.15
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance
CFB at Week 4
|
1.9 Milliliter per minute (mL/min)
Standard Deviation 6.95
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance
CFB at Week 8
|
1.8 Milliliter per minute (mL/min)
Standard Deviation 9.37
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance
CFB at Week 12
|
0.4 Milliliter per minute (mL/min)
Standard Deviation 8.06
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=84 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
Total Cholesterol, Baseline (screening Week -4)
|
4.855 mmol/L
Standard Deviation 0.9604
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
Total Cholesterol, CFB at Week 12
|
-0.073 mmol/L
Standard Deviation 0.6056
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
HDL Cholesterol, Baseline (screening Week -4)
|
1.373 mmol/L
Standard Deviation 0.3764
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
HDL Cholesterol, CFB at Week 12
|
-0.050 mmol/L
Standard Deviation 0.1646
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
LDL Cholesterol, Baseline (screening Week -4)
|
2.899 mmol/L
Standard Deviation 0.8464
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
LDL Cholesterol, CFB at Week 12
|
-0.040 mmol/L
Standard Deviation 0.4786
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
Triglycerides, Baseline (screening Week -4)
|
1.299 mmol/L
Standard Deviation 0.8672
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
Triglycerides, CFB at Week 12
|
0.005 mmol/L
Standard Deviation 0.5692
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected as assessed by protocol, at specific time points for the analysis of hematology parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Basophils, Baseline (screening Week -4)
|
0.048 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0264
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Basophils, CFB at Week 4
|
0.000 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0274
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Basophils, CFB at Week 8
|
-0.003 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0309
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Basophils, CFB at Week 12
|
-0.002 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0343
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Eosinophils, Baseline (screening Week -4)
|
0.193 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1648
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Eosinophils, CFB at Week 4
|
0.006 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1193
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Eosinophils, CFB at Week 8
|
-0.033 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.0981
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Eosinophils, CFB at Week 12
|
-0.006 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1198
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Leukocytes, Baseline (screening Week -4)
|
6.12 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.901
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Leukocytes, CFB at Week 4
|
0.09 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.524
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Leukocytes, CFB at Week 8
|
-0.24 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.364
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Leukocytes, CFB at Week 12
|
-0.11 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.210
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Lymphocytes, Baseline (screening Week -4)
|
2.076 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.6398
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Lymphocytes, CFB at Week 4
|
0.046 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.4427
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Lymphocytes, CFB at Week 8
|
-0.066 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.4864
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Lymphocytes, CFB at Week 12
|
-0.064 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.4890
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Monocytes, Baseline (screening Week -4)
|
0.470 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1897
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Monocytes, CFB at Week 4
|
-0.006 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1204
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Monocytes, CFB at Week 8
|
-0.053 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1284
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Monocytes, CFB at Week 12
|
-0.044 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.1448
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Neutrophils, Baseline (screening Week -4)
|
3.328 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.3927
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Neutrophils, CFB at Week 4
|
0.054 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.3913
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Neutrophils, CFB at Week 8
|
-0.093 Giga cells per Liter (10^9 cells/L)
Standard Deviation 1.0953
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Neutrophils, CFB at Week 12
|
0.012 Giga cells per Liter (10^9 cells/L)
Standard Deviation 0.9941
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Platelet Count, Baseline (screening Week -4)
|
256.2 Giga cells per Liter (10^9 cells/L)
Standard Deviation 70.85
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Platelet Count, CFB at Week 4
|
-0.8 Giga cells per Liter (10^9 cells/L)
Standard Deviation 33.28
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Platelet Count, CFB at Week 8
|
-3.5 Giga cells per Liter (10^9 cells/L)
Standard Deviation 30.93
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Platelet Count, CFB at Week 12
|
1.0 Giga cells per Liter (10^9 cells/L)
Standard Deviation 36.35
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count
Baseline (screening Week -4)
|
4.74 Trillion cells per liter (10^12/L)
Standard Deviation 0.398
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count
CFB at Week 4
|
0.03 Trillion cells per liter (10^12/L)
Standard Deviation 0.244
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count
CFB at Week 8
|
0.01 Trillion cells per liter (10^12/L)
Standard Deviation 0.248
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count
CFB at Week 12
|
-0.04 Trillion cells per liter (10^12/L)
Standard Deviation 0.265
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin
CFB at Week 4
|
0.3 Grams per liter (g/L)
Standard Deviation 7.02
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin
CFB at Week 8
|
-0.9 Grams per liter (g/L)
Standard Deviation 6.87
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin
CFB at Week 12
|
-2.4 Grams per liter (g/L)
Standard Deviation 7.43
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin
Baseline (screening Week -4)
|
142.9 Grams per liter (g/L)
Standard Deviation 12.14
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit
Baseline (screening Week -4)
|
0.4268 Proportion of red blood cells in blood (
Standard Deviation 0.03402
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit
CFB at Week 4
|
0.0008 Proportion of red blood cells in blood (
Standard Deviation 0.02308
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit
CFB at Week 8
|
0.0014 Proportion of red blood cells in blood (
Standard Deviation 0.02243
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit
CFB at Week 12
|
-0.0023 Proportion of red blood cells in blood (
Standard Deviation 0.02584
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume
Baseline (screening Week -4)
|
90.2 Femtoliters (fL)
Standard Deviation 4.49
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume
CFB at Week 4
|
-0.4 Femtoliters (fL)
Standard Deviation 1.74
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume
CFB at Week 8
|
0.2 Femtoliters (fL)
Standard Deviation 2.04
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume
CFB at Week 12
|
0.5 Femtoliters (fL)
Standard Deviation 2.51
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase
Baseline (Day 1)
|
100 Percentage of participants
Interval 96.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase
Week 4
|
100 Percentage of participants
Interval 96.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase
Week 8
|
99 Percentage of participants
Interval 97.0 to 100.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase
Week 12
|
90 Percentage of participants
Interval 84.0 to 96.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase
Baseline (Day 1)
|
0 Percentage of participants
Interval 0.0 to 3.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase
Week 4
|
0 Percentage of participants
Interval 0.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase
Week 8
|
1.1 Percentage of participants
Interval 0.0 to 3.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase
Week 12
|
2.2 Percentage of participants
Interval 0.0 to 5.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
Plasma samples were collected for quantitative analysis of HIV-1 RNA. CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) of >=200 c/mL - SC Injection Phase
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with treatment emergent phenotypic resistance were reported.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Phenotypic Resistance - SC Injection Phase
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 Up to Week 12Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
Plasma samples were collected for drug resistance testing. Number of participants who met CVF criteria (two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL) with treatment emergent genotypic resistance were reported.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Genotypic Resistance - SC Injection Phase
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week -3 (Baseline)Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=92 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=92 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 0
|
37 Participants
|
27 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 1
|
21 Participants
|
16 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 2
|
11 Participants
|
18 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 3
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 4
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 5
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 6
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 7
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 8
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 9
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase
Individual item score 10
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received.
A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=93 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 0
|
16 Participants
|
22 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 1
|
13 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 2
|
16 Participants
|
10 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 3
|
8 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 4
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 5
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 6
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 7
|
10 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 8
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 9
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase
Individual Item Score 10
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=87 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 9
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 0
|
21 Participants
|
19 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 1
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 2
|
19 Participants
|
15 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 3
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 4
|
9 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 5
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 6
|
4 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 7
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 8
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase
Individual Item Score 10
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 13Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= "no pain" to 10= "extreme pain". NRS questionnaire included the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=87 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 0
|
40 Participants
|
41 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 1
|
21 Participants
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 2
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 3
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 4
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 5
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 6
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 7
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 8
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 9
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase
Individual Item Score 10
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week -3 (Baseline)Population: Analysis was presented only for participants in Screening/IM Gluteal Injection Phase that completed the HIVTSQs questionnaire.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score -Screening/IM Gluteal Injection Phase
|
62.15 Scores on a scale
Standard Deviation 5.258
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQs questionnaire.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
HIVTSQs Total Score -SC Injection Phase
|
51.99 Scores on a scale
Standard Deviation 14.765
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 17Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the HIVTSQs questionnaire.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=86 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
HIVTSQs Total Score -Return to IM Gluteal Injection Phase
|
62.71 Scores on a scale
Standard Deviation 4.217
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week -3) and up to Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQs questionnaire. Only those participants with data available at specified time points have been analyzed.
HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 1
|
-1.2 Scores on a scale
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 2
|
-0.2 Scores on a scale
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 3
|
-1.5 Scores on a scale
Standard Deviation 1.93
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 4
|
-1.1 Scores on a scale
Standard Deviation 1.67
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 5
|
-1.2 Scores on a scale
Standard Deviation 1.88
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 6
|
-0.8 Scores on a scale
Standard Deviation 1.83
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 7
|
-0.2 Scores on a scale
Standard Deviation 0.93
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 8
|
-0.8 Scores on a scale
Standard Deviation 1.59
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 9
|
-1.1 Scores on a scale
Standard Deviation 1.68
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 10
|
-1.4 Scores on a scale
Standard Deviation 1.97
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 11
|
-1.0 Scores on a scale
Standard Deviation 1.47
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase
Item 12
|
-1.3 Scores on a scale
Standard Deviation 1.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week -3) and up to Week 17Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the HIVTSQs questionnaire. Only those participants with data available at specified time points have been analyzed.
HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=86 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 1
|
0.1 Scores on a scale
Standard Deviation 0.43
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 2
|
-0.1 Scores on a scale
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 3
|
0.1 Scores on a scale
Standard Deviation 0.72
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 4
|
0.0 Scores on a scale
Standard Deviation 0.63
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 5
|
0.0 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 6
|
0.0 Scores on a scale
Standard Deviation 0.95
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 7
|
0.1 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 8
|
0.0 Scores on a scale
Standard Deviation 0.55
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 9
|
0.0 Scores on a scale
Standard Deviation 0.32
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 10
|
0.1 Scores on a scale
Standard Deviation 0.57
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 11
|
0.0 Scores on a scale
Standard Deviation 0.58
|
—
|
—
|
—
|
—
|
|
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 12
|
0.2 Scores on a scale
Standard Deviation 0.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 9 and Week 17Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the HIVTSQs questionnaire. Only those participants with data available at specified time points have been analyzed.
HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=86 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 1
|
1.3 Scores on a scale
Standard Deviation 1.77
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 2
|
0.2 Scores on a scale
Standard Deviation 0.77
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 3
|
1.6 Scores on a scale
Standard Deviation 1.85
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 4
|
1.1 Scores on a scale
Standard Deviation 1.60
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 5
|
1.2 Scores on a scale
Standard Deviation 1.78
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 6
|
0.8 Scores on a scale
Standard Deviation 1.41
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 7
|
0.2 Scores on a scale
Standard Deviation 0.83
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 8
|
0.8 Scores on a scale
Standard Deviation 1.40
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 9
|
1.0 Scores on a scale
Standard Deviation 1.68
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 10
|
1.5 Scores on a scale
Standard Deviation 1.97
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 11
|
1.0 Scores on a scale
Standard Deviation 1.39
|
—
|
—
|
—
|
—
|
|
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Item 12
|
1.5 Scores on a scale
Standard Deviation 1.88
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week -4 up to Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQc questionnaire. Only those participants with data available at specified time points have been analyzed.
HIVTSQc is a 12-item questionnaire to measure treatment satisfaction in HIV participants. Individual items were rated as +3 (much more satisfied) to -3(much less satisfied). Higher the score, greater the improvement in satisfaction with each aspect of treatment and lower the score, greater the deterioration in satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on the following items:Item 1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item 5=convenience in finding treatment,Item 6=flexibility in finding treatment,Item 7=understanding HIV,Item 8=extent to which the treatment fits in with lifestyle,Item 9=recommendation of present treatment to someone else,Item 10=continuation with present form of treatment,Item 11=easy or difficult treatment,Item 12=amount of discomfort/pain involved with present form of treatment.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 1
|
0.7 Scores on a scale
Standard Deviation 2.14
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 2
|
1.8 Scores on a scale
Standard Deviation 1.40
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 3
|
0.5 Scores on a scale
Standard Deviation 2.04
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 4
|
1.2 Scores on a scale
Standard Deviation 1.75
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 5
|
1.0 Scores on a scale
Standard Deviation 2.06
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 6
|
1.3 Scores on a scale
Standard Deviation 1.76
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 7
|
2.0 Scores on a scale
Standard Deviation 1.32
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 8
|
1.4 Scores on a scale
Standard Deviation 1.77
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 9
|
1.3 Scores on a scale
Standard Deviation 1.92
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 10
|
0.9 Scores on a scale
Standard Deviation 2.11
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 11
|
1.2 Scores on a scale
Standard Deviation 1.77
|
—
|
—
|
—
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase
Item 12
|
0.5 Scores on a scale
Standard Deviation 2.18
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Week -4 up to Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQc questionnaire.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. Total treatment satisfaction change score is computed using items 1 to 11 and are summed to produce a score with a possible range of -33 to 33. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
HIVTSQc Total Score at Indicated Time Points -SC Injection Phase
|
13.4 Scores on a scale
Standard Deviation 17.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week -3 (Baseline)Population: Analysis was presented only for participants in Screening/IM Gluteal Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received.
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=93 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase
Bother of ISRs
|
1.44 Scores on a scale
Standard Deviation 0.484
|
1.53 Scores on a scale
Standard Deviation 0.568
|
—
|
—
|
—
|
|
Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase
Acceptance
|
1.51 Scores on a scale
Standard Deviation 0.676
|
1.71 Scores on a scale
Standard Deviation 0.781
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 1 and Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=93 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Bother of ISRs, Week 1
|
2.23 Scores on a scale
Standard Deviation 0.918
|
1.95 Scores on a scale
Standard Deviation 0.913
|
—
|
—
|
—
|
|
PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Bother of ISRs, Week 9
|
2.10 Scores on a scale
Standard Deviation 0.964
|
1.93 Scores on a scale
Standard Deviation 0.891
|
—
|
—
|
—
|
|
PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Acceptance, Week 1
|
2.60 Scores on a scale
Standard Deviation 1.173
|
2.28 Scores on a scale
Standard Deviation 1.167
|
—
|
—
|
—
|
|
PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Acceptance, Week 9
|
2.30 Scores on a scale
Standard Deviation 1.206
|
2.12 Scores on a scale
Standard Deviation 1.156
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Week 13Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=87 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase
Bother of ISRs
|
1.23 Scores on a scale
Standard Deviation 0.358
|
1.28 Scores on a scale
Standard Deviation 0.377
|
—
|
—
|
—
|
|
PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase
Acceptance
|
1.32 Scores on a scale
Standard Deviation 0.570
|
1.46 Scores on a scale
Standard Deviation 0.679
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline (Week -3) at Week 1 and Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=93 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=93 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Bother of ISRs, Change from Baseline at Week 1
|
0.79 Scores on a scale
Standard Deviation 0.843
|
0.41 Scores on a scale
Standard Deviation 0.909
|
—
|
—
|
—
|
|
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Bother of ISRs, Change from Baseline at Week 9
|
0.70 Scores on a scale
Standard Deviation 0.931
|
0.41 Scores on a scale
Standard Deviation 0.877
|
—
|
—
|
—
|
|
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Acceptance, Change from Baseline at Week 1
|
1.09 Scores on a scale
Standard Deviation 1.100
|
0.58 Scores on a scale
Standard Deviation 1.177
|
—
|
—
|
—
|
|
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
Acceptance, Change from Baseline at Week 9
|
0.86 Scores on a scale
Standard Deviation 1.145
|
0.44 Scores on a scale
Standard Deviation 1.103
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from Baseline (Week -3) at Week 13Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
n=87 Participants
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Bother of ISRs
|
-0.17 Scores on a scale
Standard Deviation 0.369
|
-0.24 Scores on a scale
Standard Deviation 0.537
|
—
|
—
|
—
|
|
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
Acceptance
|
-0.12 Scores on a scale
Standard Deviation 0.719
|
-0.22 Scores on a scale
Standard Deviation 0.888
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 9Population: Analysis was presented only for participants in SC Injection Phase that completed the Preference questionnaire. Only those participants with data available at specified time points have been analyzed.
A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=85 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase
Intramuscular Injections in the buttock
|
50 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase
Subcutaneous Injections in the Abdomen
|
29 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase
No preference
|
6 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 17Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the Preference questionnaire. Only those participants with data available at specified time points have been analyzed.
A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The "Preference" questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated "Which injection site do you prefer". The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference.
Outcome measures
| Measure |
CAB+RPV Screening Gluteal Injection
n=87 Participants
Participants received an IM gluteal injections of CAB LA 400 mg and RPV LA 600 mg at Week -4 during Screening/IM Gluteal Injection Phase.
|
CAB+RPV First Sub-Cutaneous (SC) Injection
Participants received a first SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 during SC abdominal injection phase.
|
CAB+RPV Second SC Injection
Participants received a second SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 4 during SC abdominal injection phase.
|
CAB+RPV Last SC Injection
Participants received a last SC injection of CAB LA 400 mg and RPV LA 600 mg on Week 8 during SC abdominal injection phase.
|
CAB+RPV Return to Intramuscular (IM) Gluteal Injection
Participants received an IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg on Week 12 and Week 16 during Return to IM gluteal injection phase
|
|---|---|---|---|---|---|
|
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase
Intramuscular Injections in the buttock
|
61 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase
Subcutaneous Injections in the Abdomen
|
21 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase
No preference
|
5 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
CAB LA 400 mg + RPV LA 600 mg - Screening Phase
Serious events: 1 serious events
Other events: 33 other events
Deaths: 1 deaths
CAB LA 400 mg + RPV LA 600 mg - SC Injection Phase
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
CAB LA 400 mg + RPV LA 600 mg - Return to IM Gluteal Injection Phase
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAB LA 400 mg + RPV LA 600 mg - Screening Phase
n=94 participants at risk
Participants received a single IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg prior to the administration of SC injection on Week -4 during the Screening Phase.
|
CAB LA 400 mg + RPV LA 600 mg - SC Injection Phase
n=93 participants at risk
Participants received a SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 in every 4 weeks (Q4W) for a total of 12 weeks during the SC abdominal Injection Phase.
|
CAB LA 400 mg + RPV LA 600 mg - Return to IM Gluteal Injection Phase
n=93 participants at risk
Participants received first IM gluteal injection (at Week 12 and week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W.
|
|---|---|---|---|
|
General disorders
Passed away due to unknown reasons
|
1.1%
1/94 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
0.00%
0/93 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
0.00%
0/93 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
Other adverse events
| Measure |
CAB LA 400 mg + RPV LA 600 mg - Screening Phase
n=94 participants at risk
Participants received a single IM gluteal injection of CAB LA 400 mg and RPV LA 600 mg prior to the administration of SC injection on Week -4 during the Screening Phase.
|
CAB LA 400 mg + RPV LA 600 mg - SC Injection Phase
n=93 participants at risk
Participants received a SC injection of CAB LA 400 mg and RPV LA 600 mg on Day 1 in every 4 weeks (Q4W) for a total of 12 weeks during the SC abdominal Injection Phase.
|
CAB LA 400 mg + RPV LA 600 mg - Return to IM Gluteal Injection Phase
n=93 participants at risk
Participants received first IM gluteal injection (at Week 12 and week 16) of CAB LA 400 mg + RPV LA 600 mg during the return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W.
|
|---|---|---|---|
|
General disorders
Injection site pain
|
30.9%
29/94 • Number of events 55 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
74.2%
69/93 • Number of events 260 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
32.3%
30/93 • Number of events 59 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site nodule
|
3.2%
3/94 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
64.5%
60/93 • Number of events 183 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
9.7%
9/93 • Number of events 13 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site erythema
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
51.6%
48/93 • Number of events 142 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
1.1%
1/93 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site swelling
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
31.2%
29/93 • Number of events 66 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
1.1%
1/93 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site induration
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
25.8%
24/93 • Number of events 66 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
2.2%
2/93 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site pruritus
|
2.1%
2/94 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
20.4%
19/93 • Number of events 40 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
1.1%
1/93 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site warmth
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
11.8%
11/93 • Number of events 22 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
0.00%
0/93 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site haematoma
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
7.5%
7/93 • Number of events 12 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
1.1%
1/93 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site bruising
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
6.5%
6/93 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
1.1%
1/93 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
General disorders
Injection site discolouration
|
0.00%
0/94 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
6.5%
6/93 • Number of events 7 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
0.00%
0/93 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
2/94 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
5.4%
5/93 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
2.2%
2/93 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected from Week -4 for screening/Gluteal injection phase, from day 1 up to 12 weeks for SC Injection Phase and from Week 12 to Week 20 for Return to IM Gluteal Injection Phase.
All-cause mortality, Non-SAEs and SAEs were reported based on the sub-study Enrolled population for the CAB LA 400 mg + RPV LA 600 mg -Screening Phase group, and based on Safety population for CAB LA 400 mg +RPV LA 600 mg - SC Injection Phase and CAB LA 400 mg +RPV LA 600 mg -Return to IM Gluteal Injection Phase groups. AEs were presented phase-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER