The purpose of this study was to determine the dosage for oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) and long-acting rilpiverine (RPV LA) and evaluate the safety, acceptability, tolerability, and pharmacokinetics (PK) of oral CAB, CAB LA, and RPV LA in virologically suppressed children and adolescents living with HIV.
IMPAACT 2017 was a Phase I/II, multi-center, open-label, non-comparative dose-finding study with the primary objective of evaluating the safety, acceptability, tolerability, and PK of oral cabotegravir (CAB) and long-acting cabotegravir (CAB LA) as well as long-acting rilpivirine (RPV LA) in adolescents living with HIV-1, who are 12 to \<18 years of age, ≥35kg, and virologically suppressed. The study design included two cohorts of participants and five study steps. In Cohort 1, Step 1 participants received either oral CAB or oral rilpivirine (RPV) for at least four weeks and up to six weeks (maximum). In Cohort 1, Step 2 participants received intramuscular injectable formulations of the study products, either CAB LA or RPV LA. Cohort 1 participants were assigned either CAB (Cohort 1C) or RPV (Cohort 1R) based on their pre-study combination Antiretroviral Therapy (cART) regimen. Participants on a PI-based and/or NNRTI-based cART regimen were assigned to Cohort 1C, and participants on a non-boosted INSTI-based cART regimen were assigned to Cohort 1R. All participants continued their pre-study cART regimen during Cohort 1. During Cohort 2, all participants discontinued their pre-study cART regimen and received both study products, CAB and RPV, at the doses established in Cohort 1. Cohort 2 participants enrolled to either Cohort 2A to receive both oral CAB + oral RPV (Step 3) followed by both CAB LA + RPV LA (Step 4) or Cohort 2B to directly receive both CAB LA + RPV LA without an oral lead-in phase (Step 5). If eligible, Cohort 1 participants were able to enroll into Cohort 2 (i.e., Cohort 1 Rollover). However, Cohort 2 participants who were not previously enrolled in Cohort 1 (i.e., Cohort 1-Naïve) were the primary group for analyses and conclusions. No participants enrolled into Cohort 2B, direct to injection (Step 5). Therefore, all references to Cohort 2 refer to Cohort 2A (Steps 3 and 4). Two interim analyses were planned. The first interim analysis established the doses for Cohort 2 and determined whether to open Cohort 2 to Cohort 1 participants who met criteria to enter Cohort 2. The second interim analysis provided justification to open Cohort 2 to additional participants who were not previously enrolled in Cohort 1. A final analysis of Cohort 1 data was performed to confirm the final doses for Cohort 2. Safety and PK evaluations were performed during Steps 1-5 and long-term safety follow-up (LSFU). Antiviral activity assessments were performed during Steps 1-5. Acceptability and tolerability were assessed during Steps 1-5 and LSFU, with all participants completing quantitative questionnaires and a subset of participants completing in-depth qualitative interviews. Additionally, parents/caregivers of a subset of U.S. participants from U.S. sites were also enrolled to complete a single in-depth qualitative interview. Because objectives related to parents/caregivers were exploratory, these outcomes are not described here. Cohort 1 participants were followed for up to 64 weeks. Participants were followed for at least four weeks in Step 1 (oral phase) and at least 12 weeks in Step 2 (injection phase). All Step 2 participants were followed (on cART, off study product) for up to an additional 48 weeks as part of LSFU after their last study product injection. If eligible, Cohort 1 participants enrolled into Cohort 2 before completing LSFU. For Cohort 1, Step 1 participants not progressing to Step 2, the last visit was targeted to be completed 28 days after the participant's last oral study product use. Cohort 2 participants were followed for up to 188 (Cohort 2B) or 192 (Cohort 2A) weeks. Participants were followed for at least four weeks in Step 3 (oral phase) and 92 weeks in Step 4/Step 5 (injection phase). After completing 92 weeks of follow-up in Step 4/Step 5 (injection phase), Cohort 2 participants who continued access to injectable study products through a mechanism external to the protocol exited the study. If it was not possible for participants to access injections of CAB LA + RPV LA from non-study sources at the completion of their Step 4 Week 96 or Step 5 Week 92 visit, participants remained in the study safety extension for up to 48 weeks. Participants who permanently discontinued injectable study product use during Cohort 2, Step 4/Step 5, or did not wish to continue to access the study products through the external mechanism after their Week 96 visit, were followed (on cART, off study product) for an additional 48 weeks as part of LSFU after their last study product injection, except for participants in the study safety extension. Participants in the study safety extension who decided to permanently discontinue injectable study product or who had not established access to study product after the 48 weeks in the study safety extension would exit the study (not enter LSFU). For Cohort 2, Step 3 participants not progressing to the injection phase, the last visit was targeted to be completed 28 days after the participant's last oral study product use. Female participants who discontinued study product use (either oral or injectable study product) due to pregnancy during Steps 1-5 were followed for an additional 48 weeks in LSFU to assess long-term safety and washout PK of the study products, except for participants in the study safety extension. Participants who became pregnant during the safety extension were only followed until the pregnancy outcome was determined.
30 mg tablets administered orally
25 mg tablets administered orally
Administered by intramuscular (IM) injection
Usc La Nichd Crs
Los Angeles, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Proportion of Participants Who Had Grade 3 or Higher Adverse Event (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related by the site investigator of record to study product through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
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Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Administered by intramuscular (IM) injection
Participants continued their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens were not provided through the study.
Pediatric Perinatal HIV NICHD CRS, Site 5127
Miami, Florida, United States
Emory University School of Medicine NICHD CRS
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, United States
Johns Hopkins Univ. Baltimore NICHD CRS
Baltimore, Maryland, United States
St. Jude Children's Research Hospital CRS
Memphis, Tennessee, United States
Baylor College of Medicine/ Texas Children's Hospital NICHD CRS
Houston, Texas, United States
Gaborone CRS
Gaborone, South-East District, Botswana
Molepolole CRS, Site 12702
Molepolole, Botswana
...and 9 more locations
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 4 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 4
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 1)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Serious Adverse Events Meeting International Conference on Harmonisation (ICH) Criteria Assessed as Related to Study Product/s (Cohort 1)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 1)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 16 weeks post-treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 1 Treatment Initiation through Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria Assessed as Related to Study Product/s (Cohort 2)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 24 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 Treatment Initiation through Week 24
Geometric Mean Area Under the Plasma Concentration-time Curve (AUC) for Step 1 Oral CAB (Cohort 1C)
AUC calculated using non-compartmental methods with linear up-log down trapezoidal rule (Phoenix WinNonlin v 8.3, Certara®). We present the geometric mean of the AUC with associated geometric coefficient of variation.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Apparent Total Body Clearance (CL/F) of Step 1 Oral CAB (Cohort 1C)
We present the geometric mean of the total body clearance of CAB and associated geometric coefficient of variation, based on analysis of intensive pharmacokinetic (PK) samples.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose
Geometric Mean Maximum Plasma Concentration (Cmax) of Oral CAB (Cohort 1C)
We present the geometric mean of the maximum plasma concentration of CAB and associated geometric coefficient of variation, based on analysis of intensive PK samples
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8 and (for Q4W dosing) 24 hours post-dose
Time of Maximum Concentration (Tmax) of Oral CAB (Cohort 1C)
We present the mean time of maximum concentration of CAB and associated standard deviation, based on analysis of intensive PK samples.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Geometric Mean Pre-dose Concentration (C0) of Oral CAB (Cohort 1C)
We present the geometric mean pre-dose CAB concentration and associated geometric coefficient of variation, based on analysis of intensive PK samples.
Time frame: Week 2: Samples collected pre-dose and 1, 2, 3, 4, 8, and (for Q4W dosing) 24 hours post-dose
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q4W)
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK sample.
Time frame: Week 16
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, 6, and 8
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q4W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, 6, 8
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q4W)
We present the geometric mean pre-dose concentrations of each injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Time frame: Week 4b, Week 8, Week 12
Geometric Mean Concentration of LA CAB/LA RPV at Week 16 (Cohort 1 Q8W)
We present the geometric mean concentration of LA CAB/LA RPV and associated geometric coefficients of variation for participants on the Q4W dosing regimen, based on analysis of the pre-dose PK sample.
Time frame: Week 16
Geometric Mean Maximum Plasma Concentration (Cmax) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the geometric mean of the maximum plasma concentration of LA CAB/LA RPV and associated geometric coefficient of variation for the first injection in participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, and 8
Time of Maximum Concentration (Tmax) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the mean time of maximum concentration of LA CAB/LA RPV at the first injection and associated standard deviation for participants on the Q8W dosing regimen, based on analysis of intensive PK samples.
Time frame: Samples collected at Weeks 4b, 5, and 8
Geometric Mean Pre-dose Concentration (C0) of LA CAB/LA RPV (Cohort 1 Q8W)
We present the geometric mean pre-dose concentration of the first injection and associated geometric coefficient of variation for participants on the Q4W dosing regimen, based on analysis of pre-dose PK samples.
Time frame: Week 4b, Week 8
Proportion of Participants With HIV-1 RNA < 50 Copies/mL (Cohort 1)
We present the proportion of participants with results of HIV-1 RNA \< 50 copies/mL at Week 16
Time frame: Week 16
Proportion of Participants Who Reported "Hurts Whole Lot" or "Hurts Worst" in Regards to Being Bothered by Pain During Injection of CAB LA or RPV LA (Cohort 1)
Results collected via administration of Pain During Injection survey to participants after receiving injection. Pain during injections was assessed using the Faces Pain Scale-Revised which includes 6 visual and text options: "no hurt," "hurts little bit," "hurts little more," "hurts even more," "hurts whole lot" and "hurts worst".
Time frame: Week 8
Median Dimension of Quality of Life Scores
A commonly used 23-item Pediatric Quality of Life Inventory, the PedsQLTM, was used to measure physical, emotional, and social dimensions of health as well as school functioning. Question responses were used to generate scores from 0-100 (100 being the best quality of life) based on the PedsQLTM guidelines. The number of participants drops slightly for the school functioning result as not all participants are eligible to answer these school-related questions.
Time frame: Week 16
Proportion of Participants Who Had Grade 3 or Higher Adverse Events (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Had Grade 3 or Higher Adverse Events Assessed as Related to Study Product/s (Cohort 2)
Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. The DAIDS grading table provides an adverse event (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: grade 1 indicates a mild event, grade 2 indicates a moderate event, grade 3 indicates a severe event, grade 4 indicates a potentially life-threatening event, and grade 5 indicates death. We present the proportion of participants with at least one grade 3 or higher AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Had Serious Adverse Events Meeting ICH Criteria, as Cited in References, Assessed as Related to Study Product/s (Cohort 2)
Adverse events (AE) were assessed as a Serious AE by ICH criteria. Per ICH, a serious AE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect (see references for additional details). We present the proportion of participants with at least one serious AE assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Permanently Discontinued Study Product Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who permanently discontinued study product due to adverse events (AEs) assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants Who Died Due to Adverse Events Assessed as Related to Study Product/s (Cohort 2)
We present the proportion of participants who died due to adverse events assessed as related to study product by the site investigator of record through 48 weeks post-Cohort 2 treatment initiation, bounded by an exact 95% confidence interval (CI).
Time frame: Cohort 2 treatment initiation through Week 48
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 24
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 24
Proportion of Participants With Plasma HIV-1 RNA >= 50 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 50 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 48
Proportion of Participants With Plasma HIV-1 RNA >= 200 Copies/mL Per the FDA Snapshot (Cohort 2)
We present the proportion of participants with HIV-1 RNA \>= 200 copies/mL and associated exact 95% CI (Clopper-Pearson) per the FDA snapshot, based on laboratory evaluations.
Time frame: Week 48
Geometric Mean Pre-dose Concentration (C0) of Oral CAB and Oral RPV (Cohort 2)
We present the geometric mean of the pre-dose concentration of oral CAB and oral RPV and associated coefficient of variation, based on analysis of pre-dose PK sample.
Time frame: Week 2
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 8 and Week 24
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 24: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 24:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 16 and Week 24
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 8 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 8 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 8 and Week 48
Geometric Mean Ratio of Pre-dose CAB and RPV Concentrations at Week 48: Pre-dose CAB and RPV Concentrations at Week 16 (Cohort 2)
We present the geometric mean of the ratios of pre-dose CAB and RPV concentrations at Week 48:Week 16 and associated coefficient of variation, based on analysis of pre-dose PK samples.
Time frame: Week 16 and Week 48