Trial Outcomes & Findings for A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants (NCT NCT05896761)
NCT ID: NCT05896761
Last Updated: 2023-09-18
Results Overview
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)
Results posted on
2023-09-18
Participant Flow
This is a sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting (LA) in Human Immunodeficiency Viruses (HIV)-infected participants currently enrolled in the Antiretroviral Therapy as Long- Acting Suppression every 2 Months (ATLAS2M \[A2M\]) study (NCT03299049).
A total of 118 participants were enrolled in the study.
Participant milestones
| Measure |
CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W)
Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at 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.
|
|---|---|---|
|
Thigh Injection Phase (Up to Week 16)
STARTED
|
54
|
64
|
|
Thigh Injection Phase (Up to Week 16)
COMPLETED
|
51
|
61
|
|
Thigh Injection Phase (Up to Week 16)
NOT COMPLETED
|
3
|
3
|
|
Return to Glu Inj Phase (Weeks 16 to 24)
STARTED
|
51
|
61
|
|
Return to Glu Inj Phase (Weeks 16 to 24)
COMPLETED
|
51
|
61
|
|
Return to Glu Inj Phase (Weeks 16 to 24)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W)
Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at 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.
|
|---|---|---|
|
Thigh Injection Phase (Up to Week 16)
Adverse Event
|
1
|
0
|
|
Thigh Injection Phase (Up to Week 16)
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants
Baseline characteristics by cohort
| Measure |
CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W)
n=54 Participants
Participants received an intramuscular (IM) injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 8 weeks later to receive first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the Return to Gluteal (Glu) Injection (Inj) Phase and subsequent gluteal injection occurred after Q8W.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W)
n=64 Participants
Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks during Thigh Injection Phase. Participants then returned to the clinic 4 weeks later received first IM gluteal injection (at 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.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.6 Years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
46.6 Years
STANDARD_DEVIATION 10.60 • n=7 Participants
|
47.5 Years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN - JAPANESE HERITAGE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
43 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)Population: Sub-study pharmacokinetic (PK) parameter Population included all participants who received at least one CAB and/or RPV thigh injection and had at least one evaluable PK parameter estimate during the sub-study. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=40 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=36 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=40 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W
|
1.67 Micrograms per milliliter
Geometric Coefficient of Variation 69.3
|
1.61 Micrograms per milliliter
Geometric Coefficient of Variation 55.5
|
1.81 Micrograms per milliliter
Geometric Coefficient of Variation 51.6
|
PRIMARY outcome
Timeframe: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=40 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=36 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=40 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W
|
103 Nanograms per milliliter
Geometric Coefficient of Variation 49.7
|
117 Nanograms per milliliter
Geometric Coefficient of Variation 54.1
|
104 Nanograms per milliliter
Geometric Coefficient of Variation 41.5
|
PRIMARY outcome
Timeframe: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=50 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=54 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W
|
4.52 Micrograms per milliliter
Geometric Coefficient of Variation 37.7
|
3.70 Micrograms per milliliter
Geometric Coefficient of Variation 40.8
|
3.36 Micrograms per milliliter
Geometric Coefficient of Variation 41.4
|
PRIMARY outcome
Timeframe: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=51 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=54 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W
|
184 Nanograms per milliliter
Geometric Coefficient of Variation 33.9
|
172 Nanograms per milliliter
Geometric Coefficient of Variation 47.4
|
146 Nanograms per milliliter
Geometric Coefficient of Variation 56.5
|
PRIMARY outcome
Timeframe: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=48 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=38 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=47 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q8W
|
4038 Hour*microgram/milliliter
Geometric Coefficient of Variation 34.6
|
3384 Hour*microgram/milliliter
Geometric Coefficient of Variation 36.6
|
3344 Hour*microgram/milliliter
Geometric Coefficient of Variation 32.9
|
PRIMARY outcome
Timeframe: Weeks -8,-7,-4 and Pre-dose on Day 1(Pre-Thigh Gluteal Injection);2 Hours post-dose on Day 1,Pre-dose on Week 8,Weeks 1 and 4 post-dose(First Thigh Injection);2 Hours post-dose on Week 8 and Weeks 9, 12 post-dose,Pre-dose on Week 16(Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=48 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=39 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=47 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q8W
|
179483 Hour*nanogram/milliliter
Geometric Coefficient of Variation 33.8
|
190641 Hour*nanogram/milliliter
Geometric Coefficient of Variation 50.4
|
162046 Hour*nanogram/milliliter
Geometric Coefficient of Variation 36.7
|
PRIMARY outcome
Timeframe: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=53 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=52 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=52 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W
|
3.34 Micrograms per milliliter
Geometric Coefficient of Variation 34.6
|
3.00 Micrograms per milliliter
Geometric Coefficient of Variation 37.8
|
2.94 Micrograms per milliliter
Geometric Coefficient of Variation 38.9
|
PRIMARY outcome
Timeframe: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=53 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=52 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=52 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W
|
170 Nanograms per milliliter
Geometric Coefficient of Variation 35.2
|
171 Nanograms per milliliter
Geometric Coefficient of Variation 39.8
|
162 Nanograms per milliliter
Geometric Coefficient of Variation 37.6
|
PRIMARY outcome
Timeframe: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=61 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=59 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=63 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W
|
4.65 Micrograms per milliliter
Geometric Coefficient of Variation 38.3
|
4.09 Micrograms per milliliter
Geometric Coefficient of Variation 35.6
|
3.95 Micrograms per milliliter
Geometric Coefficient of Variation 35.8
|
PRIMARY outcome
Timeframe: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=62 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=59 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=63 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W
|
210 Nanograms per milliliter
Geometric Coefficient of Variation 34.9
|
205 Nanograms per milliliter
Geometric Coefficient of Variation 34.8
|
197 Nanograms per milliliter
Geometric Coefficient of Variation 33.8
|
PRIMARY outcome
Timeframe: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=55 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=58 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of CAB LA Following Administration of CAB LA + RPV LA Q4W
|
2558 Hours*micrograms per milliliter
Geometric Coefficient of Variation 34.4
|
2379 Hours*micrograms per milliliter
Geometric Coefficient of Variation 34.8
|
2275 Hours*micrograms per milliliter
Geometric Coefficient of Variation 35.1
|
PRIMARY outcome
Timeframe: Weeks -4 and -3, Pre-dose on Day 1 (Pre-Thigh Gluteal Injection); 2 Hours post-dose on Day 1, Week 1 post-dose, Pre-dose on Week 4 (First Thigh Injection); 2 Hours post-dose on Week 12, Week 13 post-dose and Pre-dose on Week 16 (Last Thigh Injection)Population: Sub-study PK parameter Population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for PK analysis.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=55 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=55 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
n=58 Participants
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Area Under the Concentration Curve From 0 Hours to the Time of Next Dosing (AUC [0-tau]) of RPV LA Following Administration of CAB LA + RPV LA Q4W
|
120963 Hour*nanogram per milliliter
Geometric Coefficient of Variation 32.6
|
123197 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33.6
|
115202 Hour*nanogram per milliliter
Geometric Coefficient of Variation 33.9
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Safety Population included all randomized participants who received at least one CAB and/or RPV thigh injection. Only those participants with data available at specified time points were analyzed.
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. Data for number of participants with maximum grade or intensity for overall ISRs were reported.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=38 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=45 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
Mild or Grade 1
|
18 Participants
|
27 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
Moderate or Grade 2
|
16 Participants
|
12 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
Severe or Grade 3
|
4 Participants
|
6 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
Potentially Life-Threatening or Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
Death or Grade 5
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Safety Population. Only those participants with data available at specified time points were analyzed.
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. Data for number of participants with common AESI based on maximum severity were reported.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=38 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=45 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
Mild or Grade 1
|
18 Participants
|
27 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
Moderate or Grade 2
|
16 Participants
|
12 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
Severe or Grade 3
|
4 Participants
|
6 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
Potentially Life-Threatening or Grade 4
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
Death or Grade 5
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Safety Population
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. Number of participants who discontinued treatment due to ISRs and AESIs is presented.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=64 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase
Discontinuations due to AESI
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase
Discontinuations due to ISR
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16Population: Sub-study Intent-to-treat Exposed Population included all randomized participants who received at least one CAB and/or RPV thigh injection.
Percentage of participants with plasma HIV-1 RNA \< 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=64 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase
Baseline (Day 1)
|
100 Percentage of participants
Interval 93.0 to 100.0
|
98 Percentage of participants
Interval 95.0 to 100.0
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase
Week 4
|
100 Percentage of participants
Interval 93.0 to 100.0
|
98 Percentage of participants
Interval 95.0 to 100.0
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase
Week 8
|
96 Percentage of participants
Interval 91.0 to 100.0
|
97 Percentage of participants
Interval 93.0 to 100.0
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase
Week 12
|
94 Percentage of participants
Interval 88.0 to 100.0
|
95 Percentage of participants
Interval 90.0 to 100.0
|
—
|
|
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (Copies/mL) Using the Food and Drug (FDA) Snapshot Algorithm-Thigh Injection Phase
Week 16
|
94 Percentage of participants
Interval 88.0 to 100.0
|
95 Percentage of participants
Interval 90.0 to 100.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16Population: Sub-study Intent-to-Treat Exposed Population
Percentage of participants with plasma HIV 1 RNA \>= 50 copies/mL was obtained using the FDA snapshot algorithm. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Percentage values are rounded off.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=64 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase
Baseline (Day 1)
|
0 Percentage of participants
Interval 0.0 to 6.6
|
1.6 Percentage of participants
Interval 0.0 to 4.6
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase
Week 4
|
0 Percentage of participants
Interval 0.0 to 6.6
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase
Week 8
|
0 Percentage of participants
Interval 0.0 to 6.6
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase
Week 12
|
0 Percentage of participants
Interval 0.0 to 6.6
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
|
Percentage of Participants With Plasma HIV RNA Greater Than or Equal to (>=)50 Copies/mL Over Time as Per the FDA Snapshot Algorithm- Thigh Injection Phase
Week 16
|
0 Percentage of participants
Interval 0.0 to 6.6
|
0 Percentage of participants
Interval 0.0 to 5.6
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Intent-to-treat Exposed Population
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 copies/mL after prior suppression to \<200 copies/mL. Percentage of participants with protocol-defined CVF were reported.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=64 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Confirmed Virologic Failure Population comprised of all participants who received at least one CAB and/or RPV thigh injection who met Confirmed Virologic Failure (CVF) criteria in the sub-study. Only participants with CVF were included in the analysis.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Confirmed Virologic Failure Population. Only participants with CVF were included in the analysis.
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
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: Sub-study Intent-to-Treat Exposed Population
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 two questions regarding the maximum level of pain experienced with the most recent injections.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=64 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 0
|
14 Participants
|
21 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 8
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 9
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 10
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 1
|
13 Participants
|
16 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 2
|
7 Participants
|
6 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 3
|
6 Participants
|
7 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 4
|
5 Participants
|
4 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 5
|
4 Participants
|
4 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 6
|
3 Participants
|
2 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
Score 7
|
0 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points were 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 two questions regarding the maximum level of pain experienced with the most recent injections.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 0
|
15 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 4
|
1 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 5
|
3 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 6
|
2 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 7
|
2 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 1
|
11 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 2
|
9 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 3
|
5 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 8
|
1 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 9
|
1 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q8W Arm on Week 8- Thigh Injection Phase
Score 10
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points were 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 two questions regarding the maximum level of pain experienced with the most recent injections.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=61 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 1
|
12 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 3
|
4 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 6
|
1 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 7
|
1 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 9
|
2 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 10
|
1 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 0
|
20 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 2
|
7 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 4
|
9 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 5
|
4 Participants
|
—
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) for CAB LA + RPV LA Q4W Arm on Week 12- Thigh Injection Phase
Score 8
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Week 16Population: Sub-study Intent-to-Treat Exposed Population. 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 two questions regarding the maximum level of pain experienced with the most recent injections.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=61 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 2
|
10 Participants
|
6 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 3
|
6 Participants
|
8 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 9
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 0
|
14 Participants
|
22 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 1
|
8 Participants
|
11 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 4
|
5 Participants
|
3 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 5
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 6
|
5 Participants
|
5 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 7
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 8
|
0 Participants
|
3 Participants
|
—
|
|
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
Score 10
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Week 16Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 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 indicate dissatisfaction. Baseline was the latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=54 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=64 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase
Baseline (Day 1)
|
63.85 Scores on a scale
Standard Deviation 3.378
|
64.03 Scores on a scale
Standard Deviation 3.376
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase
Week 16
|
61.69 Scores on a scale
Standard Deviation 6.912
|
61.74 Scores on a scale
Standard Deviation 8.786
|
—
|
SECONDARY outcome
Timeframe: Study Week 24Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm -Return to Gluteal Injection Phase
|
63.78 Scores on a scale
Standard Deviation 3.743
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Week 20Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire comprises 1-12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicate dissatisfaction.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=61 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm -Return to Gluteal Injection Phase
|
63.25 Scores on a scale
Standard Deviation 4.911
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and up to Week 16Population: Sub-study Intent-to-Treat Exposed Population. 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(Item1=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,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Baseline was latest pre-treatment assessment with a non-missing value, including those from unscheduled visits.Change from Baseline was calculated by subtracting Baseline value from post-dose visit value.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=61 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 3
|
-0.7 Scores on a scale
Standard Deviation 1.32
|
-0.2 Scores on a scale
Standard Deviation 0.92
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 6
|
0.0 Scores on a scale
Standard Deviation 0.88
|
-0.3 Scores on a scale
Standard Deviation 0.86
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 8
|
-0.1 Scores on a scale
Standard Deviation 0.95
|
-0.1 Scores on a scale
Standard Deviation 0.84
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 12
|
-0.7 Scores on a scale
Standard Deviation 1.87
|
-0.5 Scores on a scale
Standard Deviation 1.29
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 1
|
-0.3 Scores on a scale
Standard Deviation 1.37
|
-0.3 Scores on a scale
Standard Deviation 1.09
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 2
|
-0.1 Scores on a scale
Standard Deviation 0.27
|
0.0 Scores on a scale
Standard Deviation 0.38
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 4
|
-0.2 Scores on a scale
Standard Deviation 0.81
|
-0.2 Scores on a scale
Standard Deviation 0.96
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 5
|
-0.1 Scores on a scale
Standard Deviation 0.63
|
-0.2 Scores on a scale
Standard Deviation 0.87
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 7
|
-0.1 Scores on a scale
Standard Deviation 0.73
|
-0.1 Scores on a scale
Standard Deviation 0.64
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 9
|
-0.2 Scores on a scale
Standard Deviation 0.92
|
-0.1 Scores on a scale
Standard Deviation 0.83
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 10
|
-0.3 Scores on a scale
Standard Deviation 1.11
|
-0.3 Scores on a scale
Standard Deviation 1.12
|
—
|
|
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 11
|
-0.1 Scores on a scale
Standard Deviation 0.83
|
-0.4 Scores on a scale
Standard Deviation 1.02
|
—
|
SECONDARY outcome
Timeframe: Study Week 16 and Study Week 24Population: Sub-study intent-to-treat exposed Population. 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 with each aspect of treatment. Data was reported for each treatment satisfaction item based on (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). Change from Study Week 16 to Study Week 24 was calculated by subtracting the Study Week 16 value from the Study Week 24 value.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 11
|
0.1 Scores on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 12
|
0.7 Scores on a scale
Standard Deviation 1.47
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 1
|
0.3 Scores on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 2
|
0.0 Scores on a scale
Standard Deviation 0.34
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 3
|
0.5 Scores on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 4
|
0.2 Scores on a scale
Standard Deviation 0.80
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 5
|
0.1 Scores on a scale
Standard Deviation 0.59
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 6
|
0.3 Scores on a scale
Standard Deviation 0.56
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 7
|
0.0 Scores on a scale
Standard Deviation 0.40
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 8
|
0.2 Scores on a scale
Standard Deviation 0.86
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 9
|
0.2 Scores on a scale
Standard Deviation 0.88
|
—
|
—
|
|
Change From Study Week 16 to Study Week 24 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q8W Arm- Return to Gluteal Injection
Item 10
|
0.2 Scores on a scale
Standard Deviation 1.14
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Week 16 and Study Week 20Population: Sub-study Intent-To-Treat Exposed Population. 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(Item1=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,Item5=convenience in finding treatment,Item6=flexibility in finding treatment,Item7=understanding HIV,Item8=extent to which the treatment fits in with lifestyle, Item9=recommendation of present treatment to someone else,Item10=continuation with present form of treatment,Item11=easy or difficult treatment,Item12=amount of discomfort/pain involved with present form of treatment).Change from Study Week 16 to Study Week 20 was calculated by subtracting the Study Week 16 value from the Study Week 20 value.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=61 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 1
|
0.2 Scores on a scale
Standard Deviation 0.73
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 7
|
0.0 Scores on a scale
Standard Deviation 0.64
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 10
|
0.2 Scores on a scale
Standard Deviation 0.80
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 2
|
0.1 Scores on a scale
Standard Deviation 0.31
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 3
|
0.3 Scores on a scale
Standard Deviation 0.85
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 4
|
0.1 Scores on a scale
Standard Deviation 0.60
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 5
|
0.1 Scores on a scale
Standard Deviation 0.69
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 6
|
0.1 Scores on a scale
Standard Deviation 0.73
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 8
|
0.0 Scores on a scale
Standard Deviation 0.52
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 9
|
0.1 Scores on a scale
Standard Deviation 0.69
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 11
|
0.3 Scores on a scale
Standard Deviation 0.79
|
—
|
—
|
|
Change From Study Week 16 to Study Week 20 in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points for CAB LA + RPV LA Q4W Arm- Return to Gluteal Injection Phase
Item 12
|
0.4 Scores on a scale
Standard Deviation 1.02
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
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 Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=61 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase
|
17.8 Scores on a scale
Standard Deviation 16.02
|
19.7 Scores on a scale
Standard Deviation 15.45
|
—
|
SECONDARY outcome
Timeframe: Up to Week 16Population: Sub-study Intent-To-Treat exposed Population. 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 (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 Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
n=61 Participants
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 2
|
1.8 Scores on a scale
Standard Deviation 1.42
|
1.9 Scores on a scale
Standard Deviation 1.42
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 11
|
1.6 Scores on a scale
Standard Deviation 1.69
|
1.7 Scores on a scale
Standard Deviation 1.65
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 12
|
1.0 Scores on a scale
Standard Deviation 2.14
|
1.4 Scores on a scale
Standard Deviation 1.74
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 1
|
1.5 Scores on a scale
Standard Deviation 1.84
|
1.7 Scores on a scale
Standard Deviation 1.71
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 3
|
1.3 Scores on a scale
Standard Deviation 1.92
|
1.5 Scores on a scale
Standard Deviation 1.70
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 4
|
1.5 Scores on a scale
Standard Deviation 1.74
|
1.8 Scores on a scale
Standard Deviation 1.48
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 5
|
1.7 Scores on a scale
Standard Deviation 1.53
|
1.6 Scores on a scale
Standard Deviation 1.66
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 6
|
1.6 Scores on a scale
Standard Deviation 1.37
|
1.7 Scores on a scale
Standard Deviation 1.50
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 7
|
1.7 Scores on a scale
Standard Deviation 1.44
|
2.0 Scores on a scale
Standard Deviation 1.35
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 8
|
1.7 Scores on a scale
Standard Deviation 1.55
|
2.0 Scores on a scale
Standard Deviation 1.47
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 9
|
1.7 Scores on a scale
Standard Deviation 1.80
|
2.0 Scores on a scale
Standard Deviation 1.57
|
—
|
|
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
Item 10
|
1.5 Scores on a scale
Standard Deviation 2.00
|
1.9 Scores on a scale
Standard Deviation 1.71
|
—
|
SECONDARY outcome
Timeframe: Up to Study Week 24Population: Sub-study Intent-To-Treat Exposed Population. 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 thigh 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 Injections in the buttock, Injections in the thigh and No preference.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=51 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm
Injections in the buttock
|
29 Participants
|
—
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm
Injections in the thigh
|
17 Participants
|
—
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm
No preference
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Study Week 20Population: Sub-study Intent-To-Treat Exposed Population. 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 thigh 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 Injections in the buttock, Injections in the thigh, Other and No preference.
Outcome measures
| Measure |
CAB+RPV Q8W First Thigh Injection
n=61 Participants
Participants received a first IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 during Thigh Injection Phase.
|
CAB+RPV Q8W Last Thigh Injection
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Week 8 during Thigh Injection Phase.
|
CAB+RPV Q8W Pre-Thigh Gluteal Injection
Participants received an IM gluteal injections of CAB LA 600 mg and RPV LA 900 mg at Week -8 during Pre-Thigh Gluteal Injection Phase.
|
|---|---|---|---|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm
Injections in the thigh
|
17 Participants
|
—
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm
Injections in the buttock
|
39 Participants
|
—
|
—
|
|
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm
No preference
|
5 Participants
|
—
|
—
|
Adverse Events
CAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection Phase
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
CAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection Phase
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
CAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection Phase
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
CAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection Phase
n=54 participants at risk
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection Phase
n=64 participants at risk
Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks Thigh Injection Phase
|
CAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection Phase
n=51 participants at risk
Participants received first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q8W.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase
n=61 participants at risk
Participants received first IM gluteal injection (at 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.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/54 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/64 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
2.0%
1/51 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
Other adverse events
| Measure |
CAB LA 600 mg + RPV LA 900 mg Q8W-Thigh Injection Phase
n=54 participants at risk
Participants received an IM injection of CAB LA 600 mg on one lateral thigh and RPV LA 900 mg into the opposite lateral thigh on Day 1 in every 8 weeks (Q8W) for a total of 16 weeks during Thigh Injection Phase.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W) -Thigh Injection Phase
n=64 participants at risk
Participants received an IM injection of CAB LA 400 mg on one lateral thigh and RPV LA 600 mg into the opposite lateral thigh on Day 1 in every 4 weeks (Q4W) for a total of 16 weeks Thigh Injection Phase
|
CAB LA 600 mg + RPV LA 900 mg Q8W- Gluteal Injection Phase
n=51 participants at risk
Participants received first IM gluteal injection (at Week 16) of CAB LA 600 mg + RPV LA 900 mg during the return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q8W.
|
CAB LA 400 mg + RPV LA 600 mg (Q4W) - Gluteal Injection Phase
n=61 participants at risk
Participants received first IM gluteal injection (at 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
|
70.4%
38/54 • Number of events 110 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
67.2%
43/64 • Number of events 163 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
5.9%
3/51 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
14.8%
9/61 • Number of events 17 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
General disorders
Injection site discomfort
|
5.6%
3/54 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
7.8%
5/64 • Number of events 8 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
General disorders
Injection site swelling
|
3.7%
2/54 • Number of events 2 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
7.8%
5/64 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
General disorders
Fatigue
|
7.4%
4/54 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
1.6%
1/64 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
General disorders
Pyrexia
|
5.6%
3/54 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
1.6%
1/64 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
Infections and infestations
COVID-19
|
11.1%
6/54 • Number of events 6 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
7.8%
5/64 • Number of events 5 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
5.9%
3/51 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
4.9%
3/61 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
Nervous system disorders
Headache
|
5.6%
3/54 • Number of events 4 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
1.6%
1/64 • Number of events 1 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
3/54 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/64 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
3/54 • Number of events 3 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/64 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/51 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. AEs were presented phase-wise.
|
0.00%
0/61 • All-cause mortality, non-serious adverse events (non-SAEs) and serious adverse events (SAEs) were collected up to 16 weeks during Thigh Injection Phase and from Week 16 to Week 24 during Return to Gluteal Injection Phase
All-cause mortality, Non-SAEs and SAEs were reported for the sub-study Safety Population which included all randomized participants who received at least one CAB and/or RPV thigh injection. 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