Human Immunodeficiency Virus Type 1 (HIV-1)
Conditions
Keywords
Cabotegravir, Efficacy, Human immunodeficiency virus, Pharmacokinetic, Rilpivirine, Safety, Tolerability
Brief summary
This sub-study will assess the pharmacokinetics (PK), safety, tolerability, virologic efficacy and health outcomes of CAB (GSK1265744) and RPV long acting (LA) in HIV-infected adult participants currently enrolled in the Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS2M \[A2M\]) study (NCT03299049).
Interventions
CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 milligrams per milliliter (mg/mL) of GSK1265744 as free acid for administration by IM injection. CAB LA injectable suspension is to be stored at up to 30 degree Celsius and should not be frozen.
RPV LA injectable suspension is a sterile white suspension containing 300 mg/mL of RPV as the free base for administration by IM injection. RPV LA injectable suspension should be kept in the outer package and stored at 2-8 degree Celsius and should not be frozen. RPV LA should also be protected from light.
Sponsors
Janssen Research & Development, LLC
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Sub-study specific Inclusion Criteria: * Capable of giving sub-study specific informed consent. * Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 152 weeks while on the ATLAS2-M study. Any disruptions in dosing during ATLAS2-M must be discussed with the Medical Monitor for a final determination of eligibility into the sub-study. * Plasma HIV-1 RNA \<50 copies/mL at Sub-Study Screening. Inclusion criteria detailed for the ATLAS-2M main study apply to the sub-study: * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin \[hCG\] test) not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: * Pre-menopausal females with one of the following: i. Documented tubal ligation ii. Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion iii. Hysterectomy iv. Documented Bilateral Oophorectomy * Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, for at least 30 days after discontinuation of all oral study medications, and for at least 52 weeks after discontinuation of CAB LA and RPV LA. * The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception.
Exclusion criteria
Sub-study specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W | 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) | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis. |
| Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W | 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) | Blood samples were collected for PK analysis. |
| Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W | 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) | Blood samples were collected for PK analysis. |
| Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W | 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) | Blood samples were collected for PK analysis. |
| 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 | 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) | Blood samples were collected for PK analysis. |
| 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 | 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) | Blood samples were collected for PK analysis. |
| Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W | 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) | Blood samples were collected for PK analysis. |
| Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W | 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) | Blood samples were collected for PK analysis. |
| Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W | 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) | Blood samples were collected for PK analysis. |
| Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W | 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) | Blood samples were collected for PK analysis. |
| 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 | 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) | Blood samples were collected for PK analysis. |
| 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 | 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) | Blood samples were collected for PK analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase | Baseline (Day 1) and Week 16 | 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. |
| 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 | Study Week 24 | 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. |
| 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 | Study Week 20 | 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. |
| Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Baseline (Day 1) and up to Week 16 | 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. |
| 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 | Study Week 16 and Study Week 24 | 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. |
| Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Up to Week 16 | 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. |
| HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase | Up to Week 16 | 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. |
| HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Up to Week 16 | 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). |
| Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm | Up to Study Week 24 | 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. |
| Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm | Up to Study Week 20 | 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. |
| 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 | Study Week 16 and Study Week 20 | 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. |
| Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Up to Week 16 | 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. |
| Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase | Up to Week 16 | 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. |
| 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) and at Weeks 4, 8, 12, 16 | 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. |
| 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) and at Weeks 4, 8, 12, 16 | 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. |
| Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase | Up to Week 16 | 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. |
| Number of Participants With Treatment Emergent Genotypic Resistance - Thigh Injection Phase | Up to Week 16 | 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. |
| Number of Participants With Treatment Emergent Phenotypic Resistance - Thigh Injection Phase | Up to Week 16 | 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. |
| Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Day 1 | 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. |
| 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 | Week 8 | 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. |
| 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 | Week 12 | 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. |
| Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Study Week 16 | 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. |
Countries
Argentina, Canada, Germany, Italy, Spain, Sweden, United States
Participant flow
Recruitment details
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).
Pre-assignment details
A total of 118 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 64 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 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
| Characteristic | CAB LA 400 mg + RPV LA 600 mg (Q4W) | Total | CAB LA 600 Milligrams (mg) + RPV LA 900 mg (Q8W) |
|---|---|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 10.6 | 47.5 Years STANDARD_DEVIATION 11.53 | 48.6 Years STANDARD_DEVIATION 12.56 |
| Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized ASIAN - JAPANESE HERITAGE | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 7 Participants | 18 Participants | 11 Participants |
| Race/Ethnicity, Customized MULTIPLE | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE | 54 Participants | 97 Participants | 43 Participants |
| Sex: Female, Male Female | 26 Participants | 45 Participants | 19 Participants |
| Sex: Female, Male Male | 38 Participants | 73 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 64 | 0 / 51 | 0 / 61 |
| other Total, other adverse events | 38 / 54 | 46 / 64 | 6 / 51 | 11 / 61 |
| serious Total, serious adverse events | 0 / 54 | 0 / 64 | 1 / 51 | 0 / 61 |
Outcome results
Primary
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
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 | 2379 Hours*micrograms per milliliter | Geometric Coefficient of Variation 34.8 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | 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 | 2275 Hours*micrograms per milliliter | Geometric Coefficient of Variation 35.1 |
90% CI: [1.08, 1.19]
90% CI: [0.97, 1.11]
Primary
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
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 | 3384 Hour*microgram/milliliter | Geometric Coefficient of Variation 36.6 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | 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 | 3344 Hour*microgram/milliliter | Geometric Coefficient of Variation 32.9 |
90% CI: [1.13, 1.3]
90% CI: [1, 1.2]
Primary
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
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 | 123197 Hour*nanogram per milliliter | Geometric Coefficient of Variation 33.6 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | 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 | 115202 Hour*nanogram per milliliter | Geometric Coefficient of Variation 33.9 |
90% CI: [1.02, 1.11]
90% CI: [1.01, 1.11]
Primary
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
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 | 190641 Hour*nanogram/milliliter | Geometric Coefficient of Variation 50.4 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | 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 | 162046 Hour*nanogram/milliliter | Geometric Coefficient of Variation 36.7 |
90% CI: [1.07, 1.23]
90% CI: [1.2, 1.38]
Primary
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W | 3.00 Micrograms per milliliter | Geometric Coefficient of Variation 37.8 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q4W | 2.94 Micrograms per milliliter | Geometric Coefficient of Variation 38.9 |
90% CI: [1.08, 1.25]
90% CI: [0.89, 1.09]
Primary
Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W | 1.61 Micrograms per milliliter | Geometric Coefficient of Variation 55.5 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Concentration at End of Dosing Interval (Ctau) of CAB LA Following Administration of CAB LA + RPV LA Q8W | 1.81 Micrograms per milliliter | Geometric Coefficient of Variation 51.6 |
90% CI: [0.831, 1.03]
90% CI: [0.816, 1.06]
Primary
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W | 171 Nanograms per milliliter | Geometric Coefficient of Variation 39.8 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q4W | 162 Nanograms per milliliter | Geometric Coefficient of Variation 37.6 |
90% CI: [0.991, 1.13]
90% CI: [0.974, 1.12]
Primary
Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W | 117 Nanograms per milliliter | Geometric Coefficient of Variation 54.1 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Concentration at End of Dosing Interval (Ctau) of RPV LA Following Administration of CAB LA + RPV LA Q8W | 104 Nanograms per milliliter | Geometric Coefficient of Variation 41.5 |
90% CI: [0.966, 1.17]
90% CI: [1.07, 1.29]
Primary
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W | 4.09 Micrograms per milliliter | Geometric Coefficient of Variation 35.6 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q4W | 3.95 Micrograms per milliliter | Geometric Coefficient of Variation 35.8 |
90% CI: [1.11, 1.25]
90% CI: [0.989, 1.14]
Primary
Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W | 3.70 Micrograms per milliliter | Geometric Coefficient of Variation 40.8 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Maximum Plasma Concentration (Cmax) of CAB LA Following Administration of CAB LA + RPV LA Q8W | 3.36 Micrograms per milliliter | Geometric Coefficient of Variation 41.4 |
90% CI: [1.22, 1.49]
90% CI: [0.975, 1.24]
Primary
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W | 205 Nanograms per milliliter | Geometric Coefficient of Variation 34.8 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q4W | 197 Nanograms per milliliter | Geometric Coefficient of Variation 33.8 |
90% CI: [1.03, 1.12]
90% CI: [0.997, 1.08]
Primary
Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W
Blood samples were collected for PK analysis.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W | 172 Nanograms per milliliter | Geometric Coefficient of Variation 47.4 |
| CAB+RPV Q8W Pre-Thigh Gluteal Injection | Maximum Plasma Concentration (Cmax) of RPV LA Following Administration of CAB LA + RPV LA Q8W | 146 Nanograms per milliliter | Geometric Coefficient of Variation 56.5 |
90% CI: [1.12, 1.4]
90% CI: [1.09, 1.28]
Secondary
Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase
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.
Time frame: Baseline (Day 1) and up to Week 16
Population: Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 11 | -0.4 Scores on a scale | Standard Deviation 1.02 |
| CAB+RPV Q8W Last Thigh Injection | 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 1.09 |
| CAB+RPV Q8W Last Thigh Injection | 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 0.64 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 2 | 0.0 Scores on a scale | Standard Deviation 0.38 |
| CAB+RPV Q8W Last Thigh Injection | 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 1.12 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 3 | -0.2 Scores on a scale | Standard Deviation 0.92 |
| CAB+RPV Q8W Last Thigh Injection | 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 0.84 |
| CAB+RPV Q8W Last Thigh Injection | 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 0.96 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 12 | -0.5 Scores on a scale | Standard Deviation 1.29 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 5 | -0.2 Scores on a scale | Standard Deviation 0.87 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 9 | -0.1 Scores on a scale | Standard Deviation 0.83 |
| CAB+RPV Q8W Last Thigh Injection | Change From Baseline in HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 6 | -0.3 Scores on a scale | Standard Deviation 0.86 |
Secondary
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
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.
Time frame: Study Week 16 and Study Week 20
Population: Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 0.6 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 0.8 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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
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
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.
Time frame: Study Week 16 and Study Week 24
Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 0.8 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 0.4 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
Secondary
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase
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).
Time frame: Up to Week 16
Population: Sub-study Intent-To-Treat exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 1.8 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 11 | 1.7 Scores on a scale | Standard Deviation 1.65 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 1 | 1.7 Scores on a scale | Standard Deviation 1.71 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 7 | 2.0 Scores on a scale | Standard Deviation 1.35 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 2 | 1.9 Scores on a scale | Standard Deviation 1.42 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 10 | 1.9 Scores on a scale | Standard Deviation 1.71 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 3 | 1.5 Scores on a scale | Standard Deviation 1.7 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 8 | 2.0 Scores on a scale | Standard Deviation 1.47 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 4 | 1.8 Scores on a scale | Standard Deviation 1.48 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 12 | 1.4 Scores on a scale | Standard Deviation 1.74 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 5 | 1.6 Scores on a scale | Standard Deviation 1.66 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 9 | 2.0 Scores on a scale | Standard Deviation 1.57 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points- Thigh Injection Phase | Item 6 | 1.7 Scores on a scale | Standard Deviation 1.5 |
Secondary
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Total Score at Indicated Time Points- Thigh Injection Phase | 19.7 Scores on a scale | Standard Deviation 15.45 |
Secondary
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
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.
Time frame: Study Week 20
Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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
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
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.
Time frame: Study Week 24
Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase
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.
Time frame: Baseline (Day 1) and Week 16
Population: Sub-study intent-to-treat exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase | Baseline (Day 1) | 64.03 Scores on a scale | Standard Deviation 3.376 |
| CAB+RPV Q8W Last Thigh Injection | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score at Indicated Time Points-Thigh Injection Phase | Week 16 | 61.74 Scores on a scale | Standard Deviation 8.786 |
Secondary
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: Sub-study Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase | Discontinuations due to AESI | 1 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase | Discontinuations due to ISR | 1 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase | Discontinuations due to AESI | 0 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs-Thigh Injection Phase | Discontinuations due to ISR | 0 Participants |
Secondary
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: Sub-study Safety Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Moderate or Grade 2 | 16 Participants |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Severe or Grade 3 | 4 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Death or Grade 5 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Mild or Grade 1 | 18 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Death or Grade 5 | 0 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Mild or Grade 1 | 27 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Moderate or Grade 2 | 12 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade- Thigh Injection Phase | Severe or Grade 3 | 6 Participants |
| CAB+RPV Q8W Last Thigh Injection | 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 |
Secondary
Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Moderate or Grade 2 | 16 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Potentially Life-Threatening or Grade 4 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Severe or Grade 3 | 4 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Death or Grade 5 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Mild or Grade 1 | 18 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Death or Grade 5 | 0 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Mild or Grade 1 | 27 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Moderate or Grade 2 | 12 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Severe or Grade 3 | 6 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Injection Site Reactions (ISRs) by Maximum Severity Grade - Thigh Injection Phase | Potentially Life-Threatening or Grade 4 | 0 Participants |
Secondary
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
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.
Time frame: Week 12
Population: Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
Secondary
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
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.
Time frame: Week 8
Population: Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase
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.
Time frame: Day 1
Population: Sub-study Intent-to-Treat Exposed Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 3 | 6 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 6 | 3 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 2 | 7 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 7 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 4 | 5 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 8 | 1 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 1 | 13 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 9 | 1 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 5 | 4 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 10 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 0 | 14 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 10 | 1 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 0 | 21 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 1 | 16 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 2 | 6 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 3 | 7 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 4 | 4 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 5 | 4 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 6 | 2 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 7 | 3 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 8 | 0 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS) on Day 1-Thigh Injection Phase | Score 9 | 0 Participants |
Secondary
Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase
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.
Time frame: Study Week 16
Population: Sub-study Intent-to-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 3 | 6 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 6 | 5 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 2 | 10 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 7 | 1 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 4 | 5 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 8 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 1 | 8 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 9 | 1 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 5 | 1 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 10 | 0 Participants |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 0 | 14 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 10 | 0 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 0 | 22 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 1 | 11 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 2 | 6 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 3 | 8 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 4 | 3 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 5 | 2 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 6 | 5 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 7 | 0 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 8 | 3 Participants |
| CAB+RPV Q8W Last Thigh Injection | Number of Participants With Post-injection Pain Using Numerical Rating Scale (NRS)- Return to Gluteal Injection Phase | Score 9 | 1 Participants |
Secondary
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm
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.
Time frame: Up to Study Week 20
Population: Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q4W Arm | No preference | 5 Participants |
Secondary
Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm
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.
Time frame: Up to Study Week 24
Population: Sub-study Intent-To-Treat Exposed Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | Number of Participants With Their Treatment Preference as Assessed Using Preference Questionnaire for CAB LA + RPV LA Q8W Arm | No preference | 5 Participants |
Secondary
Number of Participants With Treatment Emergent Genotypic Resistance - Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: 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.
Secondary
Number of Participants With Treatment Emergent Phenotypic Resistance - Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: Sub-study Confirmed Virologic Failure Population. Only participants with CVF were included in the analysis.
Secondary
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
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.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16
Population: Sub-study Intent-to-treat Exposed Population included all randomized participants who received at least one CAB and/or RPV thigh injection.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 | 95 Percentage of participants |
| CAB+RPV Q8W Last Thigh Injection | 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) | 98 Percentage of participants |
| CAB+RPV Q8W Last Thigh Injection | 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 | 98 Percentage of participants |
| CAB+RPV Q8W Last Thigh Injection | 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 | 97 Percentage of participants |
| CAB+RPV Q8W Last Thigh Injection | 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 | 95 Percentage of participants |
Secondary
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
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.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16
Population: Sub-study Intent-to-Treat Exposed Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W First Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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) | 1.6 Percentage of participants |
| CAB+RPV Q8W Last Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 |
| CAB+RPV Q8W Last Thigh Injection | 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 |
Secondary
Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase
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.
Time frame: Up to Week 16
Population: Sub-study Intent-to-treat Exposed Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB+RPV Q8W First Thigh Injection | Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase | 0 Percentage of participants |
| CAB+RPV Q8W Last Thigh Injection | Percentage of Participants With Protocol-defined Confirmed Virologic Failure (CVF)- Thigh Injection Phase | 0 Percentage of participants |