Human Immunodeficiency Virus Type 1 (HIV-1)
Conditions
Keywords
Antiretroviral agent, Rilpivirine, Cabotegravir, FLAIR, Human immunodeficiency virus
Brief summary
This study will assess the pharmacokinetics, safety, tolerability, maintenance of virological suppression and patient reported outcomes for participants receiving CAB and RPV LA injections following SC administration in the anterior abdominal wall SC tissue compared with IM administration in the gluteus medius muscle in adult participants living with HIV-1 infection in the FLAIR study (NCT02938520).
Interventions
It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.
It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
Sponsors
Janssen Pharmaceuticals
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Capable of giving signed informed consent (FLAIR and Sub-study specific informed consent) * Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 12 months while on the FLAIR study. Any disruptions in dosing during FLAIR must be discussed with the Medical Monitor for a final determination of eligibility into the sub-study. * Plasma HIV-1 RNA \<50 c/mL at Sub-Study Screening. * History of Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) vaccination (or booster dosing) is allowed prior to sub study screening and will be allowed during the conduct of the sub-study as long as the vaccine (or boosters) are not administered within 14 days of virologic load (VL) assessments. * HIV-1 infected antiretroviral therapy (ART)-naive men or women aged 18 years or greater at the time of signing the informed consent. * HIV-1 infection as documented by Screening plasma HIV-1 RNA \>=1000 cubic (c)/mL * Antiretroviral-naive (less than or equal to (\<=10) days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary * Female Participants: A female participant is eligible to participate if she is not pregnant at Screening and first day of Induction Phase (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] 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: * Documented tubal ligation; * Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; * Hysterectomy; 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, and 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. * All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (example \[e.g.,\] male condom) and on the risk of HIV transmission to an uninfected partner. * In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* More than 1 plasma HIV-1 RNA measurement 50 c/mL to \<200 c/mL (virologic blip) within 24 weeks prior to sub-study Screening visit that was investigated and found NOT to be associated with alternative causes including recent vaccinations received within 4 weeks of the viral blip or NOT associated with intercurrent illness that developed within 2-4 weeks of the viral blip. * All viral blips that occurred within 24 weeks prior to screening should be discussed with the Medical Monitor to assess whether such a participant can enroll into the sub-study. * Any Suspected Virologic Failure (HIV-RNA 200 c/mL) as defined during FLAIR study. * Participants planning to require oral bridging during participation in the FLAIR sub study. * The participant has a tattoo or any dermatological condition overlying the abdominal or gluteal regions which may interfere with interpretation of injection site reactions. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication. * Any woman of childbearing potential who is pregnant at screening will be excluded from entering the sub-study. * Any women of childbearing potential who gets pregnant while on the sub-study will have to be withdrawn from the sub-study but will be allowed to transition back to the parent FLAIR study if a pregnancy specific Informed Consent Form (ICF) is signed, and commercial access is not available at the time of pregnancy * Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study. * Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current cluster of differentiation 4+ (CD4+) cell count \<200 cells/ cubic millimeter (mm\^3) are not exclusionary. * Participants with known moderate to severe hepatic impairment. * Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. * Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrollment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrollment. * Participant who, in the investigator's judgment, poses a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. * Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: * Participants positive for HBsAg are excluded; * Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. * Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment prior to Week 48 of the Maintenance Phase must be excluded. HCV treatment on study may be permitted post Week 48, following consultation with the Medical Monitor. Participants with HCV co-infection will be allowed entry into Phase 3 studies if: * Liver enzymes meet entry criteria; * HCV Disease has undergone appropriate work-up, HCV is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. * In the event that recent biopsy or imaging data is not available or is inconclusive, the Fib-4 score will be used to verify eligibility. * A Fib-4 score \> 3.25 is exclusionary; * Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 Score Formula: (Age \* AST)/ (Platelets \* \[square root of ALT\]). * Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). * History of liver cirrhosis with or without hepatitis viral co-infection. * Ongoing or clinically relevant pancreatitis. * All participants will be screened for syphilis (rapid plasma reagin \[RPR\]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrollment. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the participant unable to receive study medication. * History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. * Current or anticipated need for chronic anti-coagulation. * ALT \>=3 times upper limit normal (ULN). * Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. * Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP). * Treatment with any of the following agents within 28 days of Screening: * radiation therapy; * cytotoxic chemotherapeutic agents; * tuberculosis (TB) therapy, with the exception of treatment of latent TB with isoniazid; * Immunomodulators that alter immune responses (such as chronic systemic corticosteroids, interleukins, or interferons). * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP. * Use of medications which are associated with Torsades de Pointes * Any evidence of primary resistance to non-nuclease reverse transcriptase inhibitors (NNRTIs) (except for K103N which is allowed), or any known resistance to Integrase inhibitors from historical resistance test results. * Participants who are human leukocyte antigen (HLA)-B\*5701 positive and are unable to use an NRTI backbone that does not contain abacavir (participants who are HLA-B\*5701 positive may be enrolled if they use a nuclease reverse transcriptase inhibitors (NRTI) backbone that does not contain abacavir; HLA-B\*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not possible). * Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening Phase to verify a result. * Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant's participation in the study of an investigational compound. * Participant has estimated creatinine clearance \<50 mL/minute (min)/1.73 meter square (m\^2) via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. * Participants who are currently participating in or anticipate to be selected for any other interventional study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA | At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injection | Blood samples were collected at indicated time points for PK analysis. |
| Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA | At screening Week-4; Day 1, Week 4, Week 8 for SC injections; and Week 12 for Return to IM gluteal injection | Blood samples were collected at indicated time points for PK analysis. |
| Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA | At screening week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injection | Blood samples were collected at indicated time points for PK analysis. |
| Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA | At screening Week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injection | Blood samples were collected at indicated time points for PK analysis. |
| Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA | At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12, for Return to IM gluteal injection | Blood samples were collected at indicated time points for PK analysis. |
| AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA | At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injection | Blood samples were collected at indicated time points for PK analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | Baseline (screening Week -4), and CFB at Week 12 | — |
| Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | Blood samples were collected as assessed by protocol, at specific time points for the analysis of hematology parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
| Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase | Baseline (Day 1) and at Weeks 4, 8, 12 | — |
| Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase | Baseline (Day 1) and at Weeks 4, 8, 12 | — |
| Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) of >=200 c/mL - SC Injection Phase | From Day 1 Up to Week 12 | Plasma samples were collected for quantitative analysis of HIV-1 RNA. CVF was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL. |
| Number of Participants With Treatment Emergent Phenotypic Resistance - SC Injection Phase | From Day 1 Up to Week 12 | 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 Treatment Emergent Genotypic Resistance - SC Injection Phase | From Day 1 Up to Week 12 | 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 Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Week -3 (Baseline) | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= no pain to 10= extreme pain. NRS questionnaire included the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC 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 the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Week 9 | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= no pain to 10= extreme pain. NRS questionnaire included the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Week 13 | A numeric rating scale was used to assess the level of pain experienced following injections with CAB + RPV. The scale contains one item and the response scale is ranging from 0= no pain to 10= extreme pain. NRS questionnaire included the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score -Screening/IM Gluteal Injection Phase | Week -3 (Baseline) | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction. |
| HIVTSQs Total Score -SC Injection Phase | At Week 9 | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction. |
| HIVTSQs Total Score -Return to IM Gluteal Injection Phase | At Week 17 | HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction. |
| Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | From Day 1 Up to Week 12 | 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. |
| Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Baseline (Week -3) and up to Week 17 | HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment. |
| Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Week 9 and Week 17 | HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment. |
| HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | From Week -4 up to Week 9 | HIVTSQc is a 12-item questionnaire to measure treatment satisfaction in HIV participants. Individual items were rated as +3 (much more satisfied) to -3(much less satisfied). Higher the score, greater the improvement in satisfaction with each aspect of treatment and lower the score, greater the deterioration in satisfaction with each aspect of treatment. Data was reported for each treatment satisfaction item based on the following items:Item 1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item 5=convenience in finding treatment,Item 6=flexibility in finding treatment,Item 7=understanding HIV,Item 8=extent to which the treatment fits in with lifestyle,Item 9=recommendation of present treatment to someone else,Item 10=continuation with present form of treatment,Item 11=easy or difficult treatment,Item 12=amount of discomfort/pain involved with present form of treatment. |
| HIVTSQc Total Score at Indicated Time Points -SC Injection Phase | From Week -4 up to Week 9 | 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. |
| Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase | At Week -3 (Baseline) | The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | At Week 1 and Week 9 | The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase | At Week 13 | The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Change from Baseline (Week -3) at Week 1 and Week 9 | The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Change from Baseline (Week -3) at Week 13 | The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV). |
| Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase | Up to Week 9 | A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The Preference questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated Which injection site do you prefer. The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference. |
| Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase | Up to Week 17 | A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The Preference questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated Which injection site do you prefer. The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference. |
| Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Baseline (Week -3) and up to Week 9 | HIVTSQs is a 12-item questionnaire and individual item scores on HIVTSQs scale are rated as 6 (very satisfied) to 0 (very dissatisfied). Higher scores represent greater satisfaction. Data was reported for each treatment satisfaction item based on the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment. |
| Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | From Day 1 Up to Week 12 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Severity of AESI was analyzed using DAIDS grading scale. The severity is categorized into grades as following: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Death. Higher grade indicates more severe condition. AESI assessed were Depression, Anxiety, Impact on creatinine, Hyperglycaemia. |
| Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase | From Day 1 Up to Week 12 | — |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase | From Week -4 Up to Week 12 | SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. |
| Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | Blood samples were collected as assessed by protocol, at specific time points for the analysis of clinical chemistry parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value. |
| Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12 | — |
Countries
Canada, Japan, South Africa, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
The sub-study Safety population, which included all enrolled participants who received at least 1 subcutaneous (SC) injection, was used to present the baseline characteristics and outcome measures. Participant flow was presented for the overall group, adverse events were presented phase wise and outcome measures were presented for the overall group or treatment wise (per dose or per overall treatment received).
Participants by arm
| Arm | Count |
|---|---|
| Cabotegravir Long Acting (CAB LA) 400 Milligrams (mg) + Rilpivirine Long Acting (RPV) LA 600 mg Participants received an intramuscular (IM) injection of CAB LA 400 mg and RPV LA 600 mg on week -4 during the Screening phase. Participants then received a sub-cutaneous (SC) injection of CAB LA 400 mg + RPV LA 600 mg on Day 1 of Week 1, Week 4 and Week 8 (once in every 4 weeks (Q4W)) for a total of 12 weeks during the SC abdominal Injection Phase. 4 weeks later, participants returned to the clinic for an IM gluteal injection (at Week 12) of CAB LA 400 mg + RPV LA 600 mg during the Return to Gluteal Injection Phase and subsequent gluteal injection occurred after Q4W at Week 16. | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Return to IM Glu Inj Phase(Week12-Week20 | Protocol Violation | 1 |
| SC Injection Phase (Day 1 up to Week 12) | Adverse Event | 2 |
| SC Injection Phase (Day 1 up to Week 12) | Protocol Violation | 1 |
| SC Injection Phase (Day 1 up to Week 12) | Withdrawal by Subject | 3 |
| Screening Phase (Week -4 up to Day 1) | Passed away due to unknown reasons | 1 |
Baseline characteristics
| Characteristic | Cabotegravir Long Acting (CAB LA) 400 Milligrams (mg) + Rilpivirine Long Acting (RPV) LA 600 mg |
|---|---|
| Age, Continuous | 42.8 Years STANDARD_DEVIATION 9.43 |
| Race/Ethnicity, Customized Black or African American | 19 Participants |
| Race/Ethnicity, Customized De-identified | 11 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 63 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 94 | 0 / 93 | 0 / 93 |
| other Total, other adverse events | 33 / 94 | 85 / 93 | 38 / 93 |
| serious Total, serious adverse events | 1 / 94 | 0 / 93 | 0 / 93 |
Outcome results
Primary
Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA
Blood samples were collected at indicated time points for PK analysis.
Time frame: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12, for Return to IM gluteal injection
Population: Analysis was performed on sub-study PK parameter set for CAB LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable AUC\[0-tau\] parameter estimated during the sub-study period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 2051.172 hour microgram per milliliter (h*µg/mL) | Geometric Coefficient of Variation 34.31 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 1997.801 hour microgram per milliliter (h*µg/mL) | Geometric Coefficient of Variation 33.94 |
| CAB+RPV Second SC Injection | Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 1943.596 hour microgram per milliliter (h*µg/mL) | Geometric Coefficient of Variation 35.25 |
| CAB+RPV Last SC Injection | Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 1943.787 hour microgram per milliliter (h*µg/mL) | Geometric Coefficient of Variation 35.53 |
| CAB+RPV Return to Intramuscular (IM) Gluteal Injection | Area Under the Plasma Concentration-time Curve From 0 Through the End of Dosing Interval (AUC[0-tau]) of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 2155.520 hour microgram per milliliter (h*µg/mL) | Geometric Coefficient of Variation 32.71 |
Comparison: To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB90% CI: [0.906, 0.983]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB90% CI: [0.895, 0.995]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within CAB90% CI: [0.876, 0.994]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the IM gluteal injections for AUC\[0-tau\] within CAB90% CI: [0.979, 1.105]Mixed effect analysisofcovariance(ANCOVA
Primary
AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA
Blood samples were collected at indicated time points for PK analysis.
Time frame: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injection
Population: Analysis was performed on sub-study PK parameter set for RPV LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable AUC\[0-tau\] parameter estimated during the sub-study period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 98003.488 h*µg/mL | Geometric Coefficient of Variation 34.31 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 98801.696 h*µg/mL | Geometric Coefficient of Variation 35.32 |
| CAB+RPV Second SC Injection | AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 95743.414 h*µg/mL | Geometric Coefficient of Variation 34.56 |
| CAB+RPV Last SC Injection | AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 93248.069 h*µg/mL | Geometric Coefficient of Variation 34.85 |
| CAB+RPV Return to Intramuscular (IM) Gluteal Injection | AUC[0-tau] of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 100006.767 h*µg/mL | Geometric Coefficient of Variation 34.78 |
Comparison: To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV90% CI: [0.932, 1.002]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV90% CI: [0.922, 0.989]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for AUC\[0-tau\] within RPV90% CI: [0.907, 0.991]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the IM gluteal injections for AUC\[0-tau\] within RPV90% CI: [0.972, 1.058]Mixed effect analysisofcovariance(ANCOVA
Primary
Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA
Blood samples were collected at indicated time points for PK analysis.
Time frame: At screening Week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injection
Population: Analysis was performed on sub-study PK parameter set for RPV LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Cmax parameter estimated during the sub-study period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 162.287 ng/mL | Geometric Coefficient of Variation 35.73 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 152.614 ng/mL | Geometric Coefficient of Variation 36.56 |
| CAB+RPV Second SC Injection | Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 148.051 ng/mL | Geometric Coefficient of Variation 35.27 |
| CAB+RPV Last SC Injection | Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 149.145 ng/mL | Geometric Coefficient of Variation 36.91 |
| CAB+RPV Return to Intramuscular (IM) Gluteal Injection | Cmax One Week Post Dose of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 154.659 ng/mL | Geometric Coefficient of Variation 36.38 |
Comparison: To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV90% CI: [0.895, 0.982]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV90% CI: [0.876, 0.963]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Cmax within RPV90% CI: [0.861, 0.952]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the IM gluteal injections for Cmax within RPV90% CI: [0.891, 0.986]Mixed effect analysisofcovariance(ANCOVA
Primary
Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA
Blood samples were collected at indicated time points for PK analysis.
Time frame: At screening Week-4; Day 1, Week 4, Week 8 for SC injections; and Week 12 for Return to IM gluteal injection
Population: Analysis was performed on sub-study Pharmacokinetic (PK) parameter set for CAB LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Ctau parameter estimated during the sub-study period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA | 2.759 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 36.64 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA | 2.670 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 37.02 |
| CAB+RPV Second SC Injection | Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA | 2.607 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 39 |
| CAB+RPV Last SC Injection | Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA | 2.632 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 38.87 |
| CAB+RPV Return to Intramuscular (IM) Gluteal Injection | Concentrations at the End of the Dosing Interval (Ctau) of CAB LA 400 mg Following Administration CAB LA + RPV LA | 2.797 microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 36.18 |
Comparison: To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB90% CI: [0.901, 0.998]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB90% CI: [0.877, 0.995]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Ctau within CAB90% CI: [0.872, 1]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the IM gluteal injections for Ctau within CAB90% CI: [0.943, 1.059]Mixed effect analysisofcovariance(ANCOVA
Primary
Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA
Blood samples were collected at indicated time points for PK analysis.
Time frame: At screening Week-4; Day 1, Week 4, Week 8 for SC abdominal injections; and Week 12 for Return to IM gluteal injection
Population: Analysis was performed on sub-study PK parameter set for RPV LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Ctau parameter estimated during the sub-study period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 137.021 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 38.51 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 138.611 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 36.43 |
| CAB+RPV Second SC Injection | Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 135.620 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 35.55 |
| CAB+RPV Last SC Injection | Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 128.590 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 39.71 |
| CAB+RPV Return to Intramuscular (IM) Gluteal Injection | Ctau of RPV LA 600 mg Following Administration of CAB LA + RPV LA | 139.879 Nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43.06 |
Comparison: To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV90% CI: [0.952, 1.056]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV90% CI: [0.921, 1.002]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Ctau within RPV90% CI: [0.885, 0.973]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the IM gluteal injections for Ctau within RPV90% CI: [0.955, 1.053]Mixed effect analysisofcovariance(ANCOVA
Primary
Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA
Blood samples were collected at indicated time points for PK analysis.
Time frame: At screening week -3; Week 1, Week 5, Week 9 for SC abdominal injections; and Week 13 for Return to IM gluteal injection
Population: Analysis was performed on sub-study PK parameter set for CAB LA, which included all participants who received at least one CAB and/or RPV SC injection and had evaluable Cmax parameter estimated during the sub-study period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 3.545 µg/mL | Geometric Coefficient of Variation 34.77 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 3.316 µg/mL | Geometric Coefficient of Variation 35.22 |
| CAB+RPV Second SC Injection | Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 3.165 µg/mL | Geometric Coefficient of Variation 36.77 |
| CAB+RPV Last SC Injection | Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 3.215 µg/mL | Geometric Coefficient of Variation 34.56 |
| CAB+RPV Return to Intramuscular (IM) Gluteal Injection | Maximum Plasma Concentration (Cmax) One Week Post Dose of CAB LA 400 mg Following Administration of CAB LA + RPV LA | 3.529 µg/mL | Geometric Coefficient of Variation 37.05 |
Comparison: To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB90% CI: [0.897, 0.99]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB90% CI: [0.86, 0.965]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the abdominal SC injection with gluteal IM injection for Cmax within CAB90% CI: [0.857, 0.966]Mixed effect analysisofcovariance(ANCOVA
Comparison: To compare the IM gluteal injections for Cmax within CAB90% CI: [0.938, 1.074]Mixed effect analysisofcovariance(ANCOVA
Secondary
Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin | Baseline (screening Week -4) | 43.1 Grams per liter (g/L) | Standard Deviation 2.66 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin | CFB at Week 4 | 0.4 Grams per liter (g/L) | Standard Deviation 2.56 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin | CFB at Week 8 | 0.8 Grams per liter (g/L) | Standard Deviation 2.2 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameter Following Administration of SC Injection: Albumin | CFB at Week 12 | -0.1 Grams per liter (g/L) | Standard Deviation 2.11 |
Secondary
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase
Blood samples were collected as assessed by protocol, at specific time points for the analysis of clinical chemistry parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALT, Baseline (screening Week -4) | 21.6 International units per liter (IU/L) | Standard Deviation 10.38 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALT, CFB at Week 4 | 1.2 International units per liter (IU/L) | Standard Deviation 8.09 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALT, CFB at Week 8 | -0.4 International units per liter (IU/L) | Standard Deviation 5.94 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALT, CFB at Week 12 | -0.7 International units per liter (IU/L) | Standard Deviation 7.32 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALP, Baseline (screening Week -4) | 62.3 International units per liter (IU/L) | Standard Deviation 14.72 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALP, CFB at Week 4 | -0.1 International units per liter (IU/L) | Standard Deviation 7.51 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALP, CFB at Week 8 | 0.7 International units per liter (IU/L) | Standard Deviation 6.66 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | ALP, CFB at Week 12 | -0.4 International units per liter (IU/L) | Standard Deviation 6.29 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | AST, Baseline (screening Week -4) | 20.1 International units per liter (IU/L) | Standard Deviation 6.27 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | AST, CFB at Week 4 | 2.2 International units per liter (IU/L) | Standard Deviation 12.33 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | AST, CFB at Week 8 | 0.1 International units per liter (IU/L) | Standard Deviation 5.52 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | AST, CFB at Week 12 | -0.2 International units per liter (IU/L) | Standard Deviation 5.46 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | Creatine phosphokinase, Baseline (screening Week -4) | 166.8 International units per liter (IU/L) | Standard Deviation 163.38 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | Creatine phosphokinase, CFB at Week 4 | 47.7 International units per liter (IU/L) | Standard Deviation 340.57 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | Creatine phosphokinase, CFB at Week 8 | 3.3 International units per liter (IU/L) | Standard Deviation 206.3 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Creatine Phosphokinase | Creatine phosphokinase, CFB at Week 12 | -0.9 International units per liter (IU/L) | Standard Deviation 162.9 |
Secondary
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance | Baseline (screening Week -4) | 93.9 Milliliter per minute (mL/min) | Standard Deviation 15.15 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance | CFB at Week 4 | 1.9 Milliliter per minute (mL/min) | Standard Deviation 6.95 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance | CFB at Week 8 | 1.8 Milliliter per minute (mL/min) | Standard Deviation 9.37 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine Clearance | CFB at Week 12 | 0.4 Milliliter per minute (mL/min) | Standard Deviation 8.06 |
Secondary
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Creatinine, Baseline (screening Week -4) | 86.23 Micromoles per liter (umol/L) | Standard Deviation 14.551 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Creatinine, CFB at Week 4 | -1.84 Micromoles per liter (umol/L) | Standard Deviation 5.811 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Creatinine, CFB at Week 8 | -1.55 Micromoles per liter (umol/L) | Standard Deviation 8.224 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Creatinine, CFB at Week 12 | -0.35 Micromoles per liter (umol/L) | Standard Deviation 7.206 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Total Bilirubin, Baseline (screening Week -4) | 9.2 Micromoles per liter (umol/L) | Standard Deviation 4.01 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Total Bilirubin, CFB at Week 4 | 0.5 Micromoles per liter (umol/L) | Standard Deviation 3.52 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Total Bilirubin, CFB at Week 8 | -0.5 Micromoles per liter (umol/L) | Standard Deviation 3.64 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Creatinine, Total Bilirubin | Total Bilirubin, CFB at Week 12 | -1.2 Micromoles per liter (umol/L) | Standard Deviation 3.21 |
Secondary
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Glucose, Baseline (screening Week -4) | 5.14 Millimoles per liter (mmol/L) | Standard Deviation 0.808 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Glucose, CFB at Week 12 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.571 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Potassium, Baseline (screening Week -4) | 4.19 Millimoles per liter (mmol/L) | Standard Deviation 0.304 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Potassium, CFB at Week 4 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.389 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Potassium, CFB at Week 8 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.307 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Potassium, CFB at Week 12 | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.346 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Sodium, Baseline (screening Week -4) | 139.8 Millimoles per liter (mmol/L) | Standard Deviation 1.81 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Sodium, CFB at Week 4 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.72 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Sodium, CFB at Week 8 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Sodium, CFB at Week 12 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 1.91 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Blood Urea Nitrogen, Baseline (screening Week -4) | 5.33 Millimoles per liter (mmol/L) | Standard Deviation 1.639 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Blood Urea Nitrogen, CFB at Week 4 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 1.206 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Blood Urea Nitrogen, CFB at Week 8 | 0.22 Millimoles per liter (mmol/L) | Standard Deviation 1.417 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Blood Urea Nitrogen, CFB at Week 12 | -0.04 Millimoles per liter (mmol/L) | Standard Deviation 1.368 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Carbon Dioxide, Baseline (screening Week -4) | 23.6 Millimoles per liter (mmol/L) | Standard Deviation 2.04 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Carbon Dioxide, CFB at Week 4 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.09 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Carbon Dioxide, CFB at Week 8 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 1.87 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Carbon Dioxide, CFB at Week 12 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 1.83 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Chloride, Baseline (screening Week -4) | 103.7 Millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Chloride, CFB at Week 4 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Chloride, CFB at Week 8 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Chloride, CFB at Week 12 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Phosphate, Baseline (screening Week -4) | 1.103 Millimoles per liter (mmol/L) | Standard Deviation 0.1651 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Phosphate, CFB at Week 4 | -0.002 Millimoles per liter (mmol/L) | Standard Deviation 0.1836 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Phosphate, CFB at Week 8 | 0.023 Millimoles per liter (mmol/L) | Standard Deviation 0.1731 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Glucose, Potassium, Sodium, Blood Urea Nitrogen, Carbon Dioxide, Chloride, Phosphate | Phosphate, CFB at Week 12 | -0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.157 |
Secondary
Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase | Baseline (screening Week -4) | 29.4 Units per liter (U/L) | Standard Deviation 17.69 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase | CFB at Week 4 | 0.3 Units per liter (U/L) | Standard Deviation 10.97 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase | CFB at Week 8 | 5.6 Units per liter (U/L) | Standard Deviation 25.61 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Chemistry Parameters Following Administration of SC Injection: Lipase | CFB at Week 12 | 1.4 Units per liter (U/L) | Standard Deviation 11.66 |
Secondary
Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides
Time frame: Baseline (screening Week -4), and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | Total Cholesterol, Baseline (screening Week -4) | 4.855 mmol/L | Standard Deviation 0.9604 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | Total Cholesterol, CFB at Week 12 | -0.073 mmol/L | Standard Deviation 0.6056 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | HDL Cholesterol, Baseline (screening Week -4) | 1.373 mmol/L | Standard Deviation 0.3764 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | HDL Cholesterol, CFB at Week 12 | -0.050 mmol/L | Standard Deviation 0.1646 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | LDL Cholesterol, Baseline (screening Week -4) | 2.899 mmol/L | Standard Deviation 0.8464 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | LDL Cholesterol, CFB at Week 12 | -0.040 mmol/L | Standard Deviation 0.4786 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | Triglycerides, Baseline (screening Week -4) | 1.299 mmol/L | Standard Deviation 0.8672 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Fasting Lipid Panels Following Administration of SC Injection: Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglycerides | Triglycerides, CFB at Week 12 | 0.005 mmol/L | Standard Deviation 0.5692 |
Secondary
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit | Baseline (screening Week -4) | 0.4268 Proportion of red blood cells in blood ( | Standard Deviation 0.03402 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit | CFB at Week 4 | 0.0008 Proportion of red blood cells in blood ( | Standard Deviation 0.02308 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit | CFB at Week 8 | 0.0014 Proportion of red blood cells in blood ( | Standard Deviation 0.02243 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hematocrit | CFB at Week 12 | -0.0023 Proportion of red blood cells in blood ( | Standard Deviation 0.02584 |
Secondary
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin | Baseline (screening Week -4) | 142.9 Grams per liter (g/L) | Standard Deviation 12.14 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin | CFB at Week 4 | 0.3 Grams per liter (g/L) | Standard Deviation 7.02 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin | CFB at Week 8 | -0.9 Grams per liter (g/L) | Standard Deviation 6.87 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Hemoglobin | CFB at Week 12 | -2.4 Grams per liter (g/L) | Standard Deviation 7.43 |
Secondary
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume | Baseline (screening Week -4) | 90.2 Femtoliters (fL) | Standard Deviation 4.49 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume | CFB at Week 4 | -0.4 Femtoliters (fL) | Standard Deviation 1.74 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume | CFB at Week 8 | 0.2 Femtoliters (fL) | Standard Deviation 2.04 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Mean Corpuscular Volume | CFB at Week 12 | 0.5 Femtoliters (fL) | Standard Deviation 2.51 |
Secondary
Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count | Baseline (screening Week -4) | 4.74 Trillion cells per liter (10^12/L) | Standard Deviation 0.398 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count | CFB at Week 4 | 0.03 Trillion cells per liter (10^12/L) | Standard Deviation 0.244 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count | CFB at Week 8 | 0.01 Trillion cells per liter (10^12/L) | Standard Deviation 0.248 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameter Following Administration of SC Injection: Red Blood Cell (RBC) Count | CFB at Week 12 | -0.04 Trillion cells per liter (10^12/L) | Standard Deviation 0.265 |
Secondary
Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count
Blood samples were collected as assessed by protocol, at specific time points for the analysis of hematology parameters. Change from Baseline value is presented and was calculated as post-dose visit value minus Baseline value.
Time frame: Baseline (screening Week -4), Change from baseline (CFB) at Week 4, CFB at Week 8, and CFB at Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Basophils, Baseline (screening Week -4) | 0.048 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0264 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Basophils, CFB at Week 4 | 0.000 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0274 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Basophils, CFB at Week 8 | -0.003 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0309 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Basophils, CFB at Week 12 | -0.002 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0343 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Eosinophils, Baseline (screening Week -4) | 0.193 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1648 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Eosinophils, CFB at Week 4 | 0.006 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1193 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Eosinophils, CFB at Week 8 | -0.033 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.0981 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Eosinophils, CFB at Week 12 | -0.006 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1198 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Leukocytes, Baseline (screening Week -4) | 6.12 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.901 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Leukocytes, CFB at Week 4 | 0.09 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.524 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Leukocytes, CFB at Week 8 | -0.24 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.364 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Leukocytes, CFB at Week 12 | -0.11 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.21 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Lymphocytes, Baseline (screening Week -4) | 2.076 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.6398 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Lymphocytes, CFB at Week 4 | 0.046 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4427 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Lymphocytes, CFB at Week 8 | -0.066 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.4864 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Lymphocytes, CFB at Week 12 | -0.064 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.489 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Monocytes, Baseline (screening Week -4) | 0.470 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1897 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Monocytes, CFB at Week 4 | -0.006 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1204 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Monocytes, CFB at Week 8 | -0.053 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1284 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Monocytes, CFB at Week 12 | -0.044 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.1448 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Neutrophils, Baseline (screening Week -4) | 3.328 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.3927 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Neutrophils, CFB at Week 4 | 0.054 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.3913 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Neutrophils, CFB at Week 8 | -0.093 Giga cells per Liter (10^9 cells/L) | Standard Deviation 1.0953 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Neutrophils, CFB at Week 12 | 0.012 Giga cells per Liter (10^9 cells/L) | Standard Deviation 0.9941 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Platelet Count, Baseline (screening Week -4) | 256.2 Giga cells per Liter (10^9 cells/L) | Standard Deviation 70.85 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Platelet Count, CFB at Week 4 | -0.8 Giga cells per Liter (10^9 cells/L) | Standard Deviation 33.28 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Platelet Count, CFB at Week 8 | -3.5 Giga cells per Liter (10^9 cells/L) | Standard Deviation 30.93 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in Hematology Parameters Following Administration of SC Injection: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelet Count | Platelet Count, CFB at Week 12 | 1.0 Giga cells per Liter (10^9 cells/L) | Standard Deviation 36.35 |
Secondary
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM 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 the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.
Time frame: Baseline (Week -3) and up to Week 17
Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the HIVTSQs questionnaire. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 1 | 0.1 Scores on a scale | Standard Deviation 0.43 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 2 | -0.1 Scores on a scale | Standard Deviation 0.35 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 3 | 0.1 Scores on a scale | Standard Deviation 0.72 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 4 | 0.0 Scores on a scale | Standard Deviation 0.63 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 5 | 0.0 Scores on a scale | Standard Deviation 0.55 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 6 | 0.0 Scores on a scale | Standard Deviation 0.95 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 7 | 0.1 Scores on a scale | Standard Deviation 0.55 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 8 | 0.0 Scores on a scale | Standard Deviation 0.55 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 9 | 0.0 Scores on a scale | Standard Deviation 0.32 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 10 | 0.1 Scores on a scale | Standard Deviation 0.57 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 11 | 0.0 Scores on a scale | Standard Deviation 0.58 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 12 | 0.2 Scores on a scale | Standard Deviation 0.79 |
Secondary
Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC 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 the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.
Time frame: Baseline (Week -3) and up to Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQs questionnaire. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 1 | -1.2 Scores on a scale | Standard Deviation 1.85 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 2 | -0.2 Scores on a scale | Standard Deviation 0.79 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 3 | -1.5 Scores on a scale | Standard Deviation 1.93 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 4 | -1.1 Scores on a scale | Standard Deviation 1.67 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 5 | -1.2 Scores on a scale | Standard Deviation 1.88 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 6 | -0.8 Scores on a scale | Standard Deviation 1.83 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 7 | -0.2 Scores on a scale | Standard Deviation 0.93 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 8 | -0.8 Scores on a scale | Standard Deviation 1.59 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 9 | -1.1 Scores on a scale | Standard Deviation 1.68 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 10 | -1.4 Scores on a scale | Standard Deviation 1.97 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 11 | -1.0 Scores on a scale | Standard Deviation 1.47 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline in HIVTSQs Individual Item Scores at Indicated Time Points -SC Injection Phase | Item 12 | -1.3 Scores on a scale | Standard Deviation 1.79 |
Secondary
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: Change from Baseline (Week -3) at Week 13
Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Bother of ISRs | -0.17 Scores on a scale | Standard Deviation 0.369 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Acceptance | -0.12 Scores on a scale | Standard Deviation 0.719 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Bother of ISRs | -0.24 Scores on a scale | Standard Deviation 0.537 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Acceptance | -0.22 Scores on a scale | Standard Deviation 0.888 |
Secondary
Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: Change from Baseline (Week -3) at Week 1 and Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Change from Baseline at Week 1 | 0.79 Scores on a scale | Standard Deviation 0.843 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Change from Baseline at Week 9 | 0.70 Scores on a scale | Standard Deviation 0.931 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Change from Baseline at Week 1 | 1.09 Scores on a scale | Standard Deviation 1.1 |
| CAB+RPV Screening Gluteal Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Change from Baseline at Week 9 | 0.86 Scores on a scale | Standard Deviation 1.145 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Change from Baseline at Week 9 | 0.44 Scores on a scale | Standard Deviation 1.103 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Change from Baseline at Week 1 | 0.41 Scores on a scale | Standard Deviation 0.909 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Change from Baseline at Week 1 | 0.58 Scores on a scale | Standard Deviation 1.177 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Change From Baseline to the PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Change from Baseline at Week 9 | 0.41 Scores on a scale | Standard Deviation 0.877 |
Secondary
Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM 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 the following items: Item 1=satisfaction with current treatment, Item 2=level of HIV control based on treatment, Item 3=any side effects of present treatment, Item 4=demands made by current treatment, Item 5=convenience in finding treatment, Item 6=flexibility in finding treatment, Item 7=understanding HIV, Item 8=extent to which the treatment fits in with lifestyle, Item 9=recommendation of present treatment to someone else, Item 10=continuation with present form of treatment, Item 11=easy or difficult treatment, Item 12=amount of discomfort/pain involved with present form of treatment.
Time frame: Week 9 and Week 17
Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the HIVTSQs questionnaire. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 1 | 1.3 Scores on a scale | Standard Deviation 1.77 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 2 | 0.2 Scores on a scale | Standard Deviation 0.77 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 3 | 1.6 Scores on a scale | Standard Deviation 1.85 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 4 | 1.1 Scores on a scale | Standard Deviation 1.6 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 5 | 1.2 Scores on a scale | Standard Deviation 1.78 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 6 | 0.8 Scores on a scale | Standard Deviation 1.41 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 7 | 0.2 Scores on a scale | Standard Deviation 0.83 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 8 | 0.8 Scores on a scale | Standard Deviation 1.4 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 9 | 1.0 Scores on a scale | Standard Deviation 1.68 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 10 | 1.5 Scores on a scale | Standard Deviation 1.97 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 11 | 1.0 Scores on a scale | Standard Deviation 1.39 |
| CAB+RPV Screening Gluteal Injection | Change From Study Week 9 to Study Week 17 in HIVTSQs Individual Item Scores at Indicated Time Points - Return to IM Gluteal Injection Phase | Item 12 | 1.5 Scores on a scale | Standard Deviation 1.88 |
Secondary
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC 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 the following items:Item 1=satisfaction with current treatment,Item2=level of HIV control based on treatment,Item3=any side effects of present treatment,Item4=demands made by current treatment,Item 5=convenience in finding treatment,Item 6=flexibility in finding treatment,Item 7=understanding HIV,Item 8=extent to which the treatment fits in with lifestyle,Item 9=recommendation of present treatment to someone else,Item 10=continuation with present form of treatment,Item 11=easy or difficult treatment,Item 12=amount of discomfort/pain involved with present form of treatment.
Time frame: From Week -4 up to Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQc questionnaire. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 1 | 0.7 Scores on a scale | Standard Deviation 2.14 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 2 | 1.8 Scores on a scale | Standard Deviation 1.4 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 3 | 0.5 Scores on a scale | Standard Deviation 2.04 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 4 | 1.2 Scores on a scale | Standard Deviation 1.75 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 5 | 1.0 Scores on a scale | Standard Deviation 2.06 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 6 | 1.3 Scores on a scale | Standard Deviation 1.76 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 7 | 2.0 Scores on a scale | Standard Deviation 1.32 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 8 | 1.4 Scores on a scale | Standard Deviation 1.77 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 9 | 1.3 Scores on a scale | Standard Deviation 1.92 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 10 | 0.9 Scores on a scale | Standard Deviation 2.11 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 11 | 1.2 Scores on a scale | Standard Deviation 1.77 |
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQc) Individual Item Score at Indicated Time Points -SC Injection Phase | Item 12 | 0.5 Scores on a scale | Standard Deviation 2.18 |
Secondary
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score -Screening/IM Gluteal Injection Phase
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.
Time frame: Week -3 (Baseline)
Population: Analysis was presented only for participants in Screening/IM Gluteal Injection Phase that completed the HIVTSQs questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQs) Total Score -Screening/IM Gluteal Injection Phase | 62.15 Scores on a scale | Standard Deviation 5.258 |
Secondary
HIVTSQc Total Score at Indicated Time Points -SC 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: From Week -4 up to Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQc questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | HIVTSQc Total Score at Indicated Time Points -SC Injection Phase | 13.4 Scores on a scale | Standard Deviation 17.79 |
Secondary
HIVTSQs Total Score -Return to IM Gluteal Injection Phase
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.
Time frame: At Week 17
Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the HIVTSQs questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | HIVTSQs Total Score -Return to IM Gluteal Injection Phase | 62.71 Scores on a scale | Standard Deviation 4.217 |
Secondary
HIVTSQs Total Score -SC Injection Phase
HIVTSQ is a self-completion measure specifically designed to measure treatment satisfaction in HIV participants. HIVTSQs questionnaire includes 12 questions and the total treatment satisfaction score is computed with items 1-11 and summed to produce a total score with a possible range of 0 to 66. Higher scores indicate a greater satisfaction and a lower score indicates dissatisfaction.
Time frame: At Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the HIVTSQs questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | HIVTSQs Total Score -SC Injection Phase | 51.99 Scores on a scale | Standard Deviation 14.765 |
Secondary
Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase
Time frame: From Day 1 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase | Discontinuations due to AESI | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants Who Discontinue Treatment Due to ISRs and AESIs - SC Injection Phase | Discontinuations due to ISR | 5 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase
SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs.
Time frame: From Week -4 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase | Any AEs | 90 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From the Last IM Gluteal Injection in Screening Phase to the End of the SC Injection Phase | Any SAEs | 0 Participants |
Secondary
Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC 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. AESI assessed were Depression, Anxiety, Impact on creatinine, Hyperglycaemia.
Time frame: From Day 1 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Severe or Grade 3 Anxiety | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Any Depression | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Mild or Grade 1 Depression | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Moderate or Grade 2 Depression | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Severe or Grade 3 Depression | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Potentially Life-Threatening or Grade 4 Depression | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Death or Grade 5 Depression | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Any Anxiety | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Mild or Grade 1 Anxiety | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Moderate or Grade 2 Anxiety | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Potentially Life-Threatening or Grade 4 Anxiety | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Death or Grade 5 Anxiety | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Any Impact on Creatinine | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Mild or Grade 1 Impact on Creatinine | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Moderate or Grade 2 Impact on Creatinine | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Severe or Grade 3 Impact on Creatinine | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Potentially Life-Threatening or Grade 4 Impact on Creatinine | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Death or Grade 5 Impact on Creatinine | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Any Hyperglycaemia | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Mild or Grade 1 Hyperglycaemia | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Moderate or Grade 2 Hyperglycaemia | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Severe or Grade 3 Hyperglycaemia | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Potentially Life-Threatening or Grade 4 Hyperglycaemia | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Adverse Events of Special Interest (AESI) Based on Maximum Severity Grade - SC Injection Phase | Death or Grade 5 Hyperglycaemia | 0 Participants |
Secondary
Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC 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.
Time frame: From Day 1 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | ISRs | 85 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | Mild or Grade 1 ISRs | 43 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | Moderate or Grade 2 ISRs | 36 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | Severe or Grade 3 ISRs | 6 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | Potentially Life-Threatening or Grade 4 ISRs | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Injection Site Reactions (ISRs) and by Maximum Severity - SC Injection Phase | Death or Grade 5 ISRs | 0 Participants |
Secondary
Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM 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 the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: Week 13
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 3 | 7 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 6 | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 2 | 10 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 7 | 2 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 4 | 3 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 8 | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 1 | 21 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 9 | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 5 | 3 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 10 | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 0 | 40 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 10 | 0 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 0 | 41 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 1 | 13 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 2 | 12 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 3 | 9 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 4 | 3 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 5 | 5 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 6 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 7 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 8 | 0 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 13- Return to IM Gluteal Injection Phase | Individual Item Score 9 | 0 Participants |
Secondary
Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC 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 the questions regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: Week 9
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 3 | 9 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 6 | 4 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 2 | 19 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 7 | 3 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 4 | 9 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 8 | 5 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 1 | 9 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 9 | 4 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 5 | 4 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 10 | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 0 | 21 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 10 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 0 | 19 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 1 | 11 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 2 | 15 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 3 | 13 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 4 | 6 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 5 | 7 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 6 | 9 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 7 | 3 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 8 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using NRS on Week 9- SC Injection Phase | Individual Item Score 9 | 0 Participants |
Secondary
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC 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 the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: Day 1
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 3 | 8 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 6 | 3 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 2 | 16 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 7 | 10 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 4 | 6 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 8 | 6 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 1 | 13 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 9 | 7 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 5 | 6 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 10 | 2 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 0 | 16 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 10 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 0 | 22 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 1 | 19 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 2 | 10 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 3 | 13 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 4 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 5 | 7 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 6 | 4 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 7 | 7 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 8 | 5 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week 1 - SC Injection Phase | Individual Item Score 9 | 2 Participants |
Secondary
Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM 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 the question regarding the maximum level of pain experienced with the most recent injections. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: Week -3 (Baseline)
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 3 | 7 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 6 | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 2 | 11 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 7 | 6 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 4 | 5 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 8 | 3 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 1 | 21 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 9 | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 5 | 1 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 10 | 0 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 0 | 37 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 10 | 2 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 0 | 27 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 1 | 16 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 2 | 18 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 3 | 9 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 4 | 5 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 5 | 6 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 6 | 3 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 7 | 4 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 8 | 1 Participants |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Number of Participants With Post-injection Pain Assessment Using Numeric Rating Scale (NRS) on Week-3 - Screening/IM Gluteal Injection Phase | Individual item score 9 | 1 Participants |
Secondary
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase
A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The Preference questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated Which injection site do you prefer. The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference.
Time frame: Up to Week 17
Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the Preference questionnaire. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase | Intramuscular Injections in the buttock | 61 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase | Subcutaneous Injections in the Abdomen | 21 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 17 - Return to IM Gluteal Injection Phase | No preference | 5 Participants |
Secondary
Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase
A preference questionnaire was used to assess participant's preference for the subcutaneous injections compared with the gluteal injections. The Preference questionnaire included a single item question evaluating preference of HIV treatment. Participants were required to provide their response to Question, which stated Which injection site do you prefer. The responses included Intramuscular Injections in the buttock, Subcutaneous Injections in the Abdomen and No preference.
Time frame: Up to Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the Preference questionnaire. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase | Intramuscular Injections in the buttock | 50 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase | Subcutaneous Injections in the Abdomen | 29 Participants |
| CAB+RPV Screening Gluteal Injection | Number of Participants With Their Treatment Preference Assessed Using Preference Questionnaire on Week 9 - SC Injection Phase | No preference | 6 Participants |
Secondary
Number of Participants With Treatment Emergent Genotypic Resistance - SC 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: From Day 1 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Treatment Emergent Genotypic Resistance - SC Injection Phase | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Phenotypic Resistance - SC 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: From Day 1 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB+RPV Screening Gluteal Injection | Number of Participants With Treatment Emergent Phenotypic Resistance - SC Injection Phase | 0 Participants |
Secondary
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase | Baseline (Day 1) | 100 Percentage of participants |
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase | Week 4 | 100 Percentage of participants |
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase | Week 8 | 99 Percentage of participants |
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (c/mL) Using the Food and Drug Administration (FDA) Snapshot Algorithm - SC Injection Phase | Week 12 | 90 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase | Baseline (Day 1) | 0 Percentage of participants |
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase | Week 4 | 0 Percentage of participants |
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase | Week 8 | 1.1 Percentage of participants |
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Plasma HIV RNA Greater Than Equal to (>=) 50 c/mL as Per FDA Snapshot Algorithm - SC Injection Phase | Week 12 | 2.2 Percentage of participants |
Secondary
Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) of >=200 c/mL - SC 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 c/mL after prior suppression to \<200 c/mL.
Time frame: From Day 1 Up to Week 12
Population: Analysis was performed on sub-study safety set, which included all enrolled participants who received at least one CAB and/or RPV SC injection.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB+RPV Screening Gluteal Injection | Percentage of Participants With Protocol Defined Confirmed Virologic Failure (CVF) of >=200 c/mL - SC Injection Phase | 0 Percentage of participants |
Secondary
Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: At Week -3 (Baseline)
Population: Analysis was presented only for participants in Screening/IM Gluteal Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase | Bother of ISRs | 1.44 Scores on a scale | Standard Deviation 0.484 |
| CAB+RPV Screening Gluteal Injection | Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase | Acceptance | 1.51 Scores on a scale | Standard Deviation 0.676 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase | Bother of ISRs | 1.53 Scores on a scale | Standard Deviation 0.568 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | Perception of Injection (PIN) Questionnaire in Domain Scores and Individual Item Scores- Screening/IM Gluteal Injection Phase | Acceptance | 1.71 Scores on a scale | Standard Deviation 0.781 |
Secondary
PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: At Week 1 and Week 9
Population: Analysis was presented only for participants in SC Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Week 1 | 2.23 Scores on a scale | Standard Deviation 0.918 |
| CAB+RPV Screening Gluteal Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Week 9 | 2.10 Scores on a scale | Standard Deviation 0.964 |
| CAB+RPV Screening Gluteal Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Week 1 | 2.60 Scores on a scale | Standard Deviation 1.173 |
| CAB+RPV Screening Gluteal Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Week 9 | 2.30 Scores on a scale | Standard Deviation 1.206 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Week 9 | 2.12 Scores on a scale | Standard Deviation 1.156 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Week 1 | 1.95 Scores on a scale | Standard Deviation 0.913 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Acceptance, Week 1 | 2.28 Scores on a scale | Standard Deviation 1.167 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | PIN Questionnaire in Domain Scores and Individual Item Scores at Indicated Time Points - SC Injection Phase | Bother of ISRs, Week 9 | 1.93 Scores on a scale | Standard Deviation 0.891 |
Secondary
PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase
The PIN questionnaire is characterized by the dimension scores based on 4 domains including Bother from injection site reactions (ISRs), Acceptability, Leg movement and Sleep categories. The objective of this endpoint is to present analysis of 2 (out of 4) PIN domains: Bother from ISRs and Acceptability. This questionnaire contains 21 items that measure pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside of a clinical trial. Domain scores were calculated as a mean of all items with the domain. Scores range from 1 to 5,and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of vaccination, and 5 the most unfavorable. Higher scores represent worse perception of injection. The objective of this outcome measure was to present the data separately for each treatment received (CAB, RPV).
Time frame: At Week 13
Population: Analysis was presented only for participants in Return to IM Gluteal Injection Phase that completed the PIN questionnaire based on intervention received. The participants were analyzed according to the treatment they received. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB+RPV Screening Gluteal Injection | PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase | Bother of ISRs | 1.23 Scores on a scale | Standard Deviation 0.358 |
| CAB+RPV Screening Gluteal Injection | PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase | Acceptance | 1.32 Scores on a scale | Standard Deviation 0.57 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase | Bother of ISRs | 1.28 Scores on a scale | Standard Deviation 0.377 |
| CAB+RPV First Sub-Cutaneous (SC) Injection | PIN Questionnaire in Domain Scores and Individual Item Scores - Return to IM Gluteal Injection Phase | Acceptance | 1.46 Scores on a scale | Standard Deviation 0.679 |