HIV-1 Infection
Conditions
Brief summary
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric participants who are virologically suppressed (VS) on antiretroviral therapy (ART) for ≥3 months or are treatment-naive (TN). The primary purposes of the study are 1) to examine the steady-state pharmacokinetics (PK) of ISL in plasma; 2) the steady-state PK of ISL-triphosphate (ISL-TP) in peripheral blood mononuclear cells (PBMCs); and 3) to examine the safety and tolerability of ISL/DOR.
Detailed description
As of protocol amendment 03 (approved 08-Feb-2022), all participants have been discontinued from study therapy and will be switched to non-study antiretroviral therapy and monitored for safety. The present results cover data obtained through the cut-off date of 30-Mar-2022, and will be updated once monitoring is completed.
Interventions
DRUGDOR/ISL
100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Is HIV-1 positive, is \<18 years of age, and weighs ≥35 kg at screening. * VS Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA \<50 copies/mL and has been receiving continuous, stable oral 2-drug or 3-drug combination ART ± PK booster with documented viral suppression for ≥3 months prior to providing documented informed consent/assent and has no history of prior virologic treatment failure on any past or current regimen. * TN Participants: Is HIV-1 positive at Screening with plasma HIV-1 RNA ≥500 copies/mL and is naive to ART defined as having received \<=10 days of prior therapy with any antiretrovirals following HIV-1 diagnosis other than pre-exposure prophylaxis (PrEP) or potentially exposed person (PEP). * If female, is not pregnant or breastfeeding, and is either 1) not a woman of childbearing potential (WOCBP) or 2) is a WOCBP and is using acceptable contraception or is abstinent.
Exclusion criteria
* Has HIV-2 infection. * Has hypersensitivity or other contraindication to any of the components of the study drugs as determined by the investigator. * Has an active diagnosis of hepatitis due to any cause, including active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive). * Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma. * Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate. * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 45 days prior to Day 1 through the study treatment period. * Is currently taking long-acting cabotegravir-rilpivirine. * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period. * Has a documented or known virologic resistance to DOR/ISL (DOR resistance substitutions in reverse transcriptase: V106A/M, V108I, Y188L, H221Y, P225H, F227C/L, M230I/L, L234I, P236L, or Y318F; ISL resistance substitution in reverse transcriptase: M184V/I). * Has exclusionary laboratory values. * Is female and expecting to conceive or donate eggs at any time during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Discontinuing From Study Treatment Due to an AE | Up to 24 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Maximum Plasma Concentration (Cmax) of ISL | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | The Cmax of ISL in plasma was determined at steady state. |
| Time to Reach Maximum Plasma Concentration (Tmax) of ISL | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | The Tmax of ISL in plasma was determined at steady state. |
| Apparent Plasma Terminal Half-life (t½) of ISL | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | The t½ of ISL in plasma was determined at steady state. |
| Apparent Total Clearance From Plasma (CL/F) of ISL | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | The CL/F of ISL from plasma was determined at steady state. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | The Vz/F of ISL was determined at steady state. |
| AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs) | Pre-dose, and 4 and 24 hours post-dose on Day 28 | The AUC0-24 of ISL-TP in PBMCs was determined at steady state. |
| Cmax of ISL-TP in PBMCs | Pre-dose, and 4, and 24 hours post-dose on Day 28 | The Cmax of ISL-TP in PBMCs was determined at steady state. |
| C24 of ISL-TP in PBMCs | 24 hours post-dose on Day 28 | The C24 of ISL-TP in PBMCs was determined at steady state. |
| Number of Participants Experiencing ≥1 Adverse Event (AE) | Up to 24 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL) | Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28 | The AUC0-24 of ISL in plasma was determined at steady state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of VS Participants With HIV-1 RNA <50 Copies/mL | Week 24 | The percentage of VS participants with HIV-1 RNA \<50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. |
| Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL | Week 24 | The percentage of TN participants with HIV-1 RNA \<50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. |
| Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants | Baseline (Day 1) and Week 24 | CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts. |
| Change From Baseline in CD4+ T-cells in TN Participants | Baseline (Day 1) and Week 24 | CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts. |
| Incidence of Viral Drug Resistance to DOR | Up to 24 weeks | The number of participants with viral drug resistance to DOR was determined. |
| Incidence of Viral Drug Resistance to ISL | Up to 24 weeks | The number of participants with viral drug resistance to ISL was determined. |
| Palatability of DOR/ISL Tablet | Baseline (Day 1), Week 4, and Week 24 | The palatability of the DOR/ISL tablet (whole or split) was assessed with a modified 5-point facial hedonic scale. Responses ranged from 1 (very bad) to 5 (very good). Data show the number of VS and TN participants responding at each score at the designated time points. |
| Acceptability of DOR/ISL Tablet | Baseline (Day 1), Week 4, and Week 24 | The acceptability of the DOR/ISL tablet (whole or split) was assessed. Acceptability was assessed by monitoring for refusing the tablet, throwing up or spitting out the tablet, and gagging on the tablet. Data show the number of VS and TN participants responding at each score at the designated time points. |
| Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL | Week 24 | The percentage of VS participants with HIV-1 RNA ≥50 copies/mL was determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL. |
Countries
Italy, Russia, South Africa, Thailand, United States
Participant flow
Recruitment details
Pediatric participants who were ≥35 kg body weight and \<18 years of age were recruited at 18 study sites located in Italy, Russian Federation, Thailand, South Africa, and the United States.
Participants by arm
| Arm | Count |
|---|---|
| DOR/ISL: Virologically Suppressed Cohort VS participants (had taken stable 2- or 3-drug combination ART for ≥3 months) pediatric participants with HIV-1 infection receive DOR/ISL for 96 weeks. | 37 |
| DOR/ISL: Treatment Naive Cohort TN participants with HIV-1 infection receive DOR/ISL for 96 weeks. | 3 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded from results due to informed consent issue | 2 | 0 |
| Overall Study | Ongoing for safety monitoring | 14 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | DOR/ISL: Virologically Suppressed Cohort | DOR/ISL: Treatment Naive Cohort | Total |
|---|---|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 2.2 | 15.7 years STANDARD_DEVIATION 1.5 | 14.8 years STANDARD_DEVIATION 2.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants | 3 Participants | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 3 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 0 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 0 Participants | 8 Participants |
| Sex: Female, Male Female | 14 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male Male | 23 Participants | 2 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 3 | 0 / 14 | 0 / 1 |
| other Total, other adverse events | 13 / 37 | 2 / 3 | 12 / 14 | 1 / 1 |
| serious Total, serious adverse events | 1 / 37 | 0 / 3 | 0 / 14 | 0 / 1 |
Outcome results
Primary
Apparent Plasma Terminal Half-life (t½) of ISL
The t½ of ISL in plasma was determined at steady state.
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Apparent Plasma Terminal Half-life (t½) of ISL | 16.5 hours | Geometric Coefficient of Variation 70 |
Primary
Apparent Total Clearance From Plasma (CL/F) of ISL
The CL/F of ISL from plasma was determined at steady state.
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Apparent Total Clearance From Plasma (CL/F) of ISL | 22.5 L/hr | Geometric Coefficient of Variation 28.6 |
Primary
Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL
The Vz/F of ISL was determined at steady state.
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Apparent Volume of Distribution During Terminal Phase (Vz/F) of ISL | 536 Liters | Geometric Coefficient of Variation 61.1 |
Primary
Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL)
The AUC0-24 of ISL in plasma was determined at steady state.
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Area Under the Plasma Drug Concentration-time Curve From 0 to 24 Hours Post-dose (AUC0-24) of Islatravir (ISL) | 0.114 hr*µmol/L | Geometric Coefficient of Variation 28.6 |
Primary
AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs)
The AUC0-24 of ISL-TP in PBMCs was determined at steady state.
Time frame: Pre-dose, and 4 and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | AUC0-last of ISL-triphosphate (ISL-TP) in Peripheral Blood Mononuclear Cells (PBMCs) | 52.3 hr*pmol/10^6 cells | Geometric Coefficient of Variation 74.9 |
Primary
C24 of ISL-TP in PBMCs
The C24 of ISL-TP in PBMCs was determined at steady state.
Time frame: 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | C24 of ISL-TP in PBMCs | 2.05 pmol/10^6 cells | Geometric Coefficient of Variation 71.7 |
Primary
Cmax of ISL-TP in PBMCs
The Cmax of ISL-TP in PBMCs was determined at steady state.
Time frame: Pre-dose, and 4, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PBMC PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on intracellular PBMC PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Cmax of ISL-TP in PBMCs | 2.87 pmol/10^6 cells | Geometric Coefficient of Variation 91.6 |
Primary
Maximum Plasma Concentration (Cmax) of ISL
The Cmax of ISL in plasma was determined at steady state.
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Maximum Plasma Concentration (Cmax) of ISL | 0.0245 µmol/L | Geometric Coefficient of Variation 53.4 |
Primary
Number of Participants Discontinuing From Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 24 weeks
Population: All participants who received ≥1 dose of study intervention are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Number of Participants Discontinuing From Study Treatment Due to an AE | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Number of Participants Discontinuing From Study Treatment Due to an AE | 0 Participants |
Primary
Number of Participants Experiencing ≥1 Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: Up to 24 weeks
Population: All participants who received ≥1 dose of study intervention are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Number of Participants Experiencing ≥1 Adverse Event (AE) | 21 Participants |
| DOR/ISL: Treatment Naive Cohort | Number of Participants Experiencing ≥1 Adverse Event (AE) | 2 Participants |
Primary
Time to Reach Maximum Plasma Concentration (Tmax) of ISL
The Tmax of ISL in plasma was determined at steady state.
Time frame: Pre-dose, and 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose on Day 28
Population: A subset of VS participants was included in the Intensive PK Cohort, consisting of participants who complied with the protocol sufficiently to ensure data were likely to exhibit the effects of the study intervention on plasma PK parameters.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Time to Reach Maximum Plasma Concentration (Tmax) of ISL | 1.00 hours |
Secondary
Acceptability of DOR/ISL Tablet
The acceptability of the DOR/ISL tablet (whole or split) was assessed. Acceptability was assessed by monitoring for refusing the tablet, throwing up or spitting out the tablet, and gagging on the tablet. Data show the number of VS and TN participants responding at each score at the designated time points.
Time frame: Baseline (Day 1), Week 4, and Week 24
Population: All VS and TN participants who received ≥1 dose of study intervention and have data available are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Refusing - Week 4 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Throwing Up/Spitting Out - Week 24 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Throwing Up/Spitting Out - Day 1 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Gagging - Day 1 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Refusing - Week 24 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Gagging - Week 4 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Throwing Up/Spitting Out - Week 4 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Gagging - Week 24 | 1 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Acceptability of DOR/ISL Tablet | Refusing - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Gagging - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Refusing - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Refusing - Week 4 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Refusing - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Throwing Up/Spitting Out - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Throwing Up/Spitting Out - Week 4 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Throwing Up/Spitting Out - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Gagging - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Acceptability of DOR/ISL Tablet | Gagging - Week 4 | 0 Participants |
Secondary
Change From Baseline in CD4+ T-cells in TN Participants
CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts.
Time frame: Baseline (Day 1) and Week 24
Population: TN participants who received ≥1 dose of study intervention and had baseline and Week 24 data available are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Change From Baseline in CD4+ T-cells in TN Participants | 705.0 cells/mm^3 |
Secondary
Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants
CD4+ T-cell counts were measured by a central laboratory. Negative and positive results represent a decrease and increase, respectively, from baseline CD4+ T-cell counts.
Time frame: Baseline (Day 1) and Week 24
Population: All VS participants who received ≥1 dose of study intervention and had data available are included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Change From Baseline in Cluster of Differentiation 4+ (CD4+) T-cells in VS Participants | -112.1 cells/mm^3 |
Secondary
Incidence of Viral Drug Resistance to DOR
The number of participants with viral drug resistance to DOR was determined.
Time frame: Up to 24 weeks
Population: Participants who received ≥1 dose of study intervention are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Incidence of Viral Drug Resistance to DOR | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Incidence of Viral Drug Resistance to DOR | 0 Participants |
Secondary
Incidence of Viral Drug Resistance to ISL
The number of participants with viral drug resistance to ISL was determined.
Time frame: Up to 24 weeks
Population: Participants who received ≥1 dose of study intervention are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Incidence of Viral Drug Resistance to ISL | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Incidence of Viral Drug Resistance to ISL | 0 Participants |
Secondary
Palatability of DOR/ISL Tablet
The palatability of the DOR/ISL tablet (whole or split) was assessed with a modified 5-point facial hedonic scale. Responses ranged from 1 (very bad) to 5 (very good). Data show the number of VS and TN participants responding at each score at the designated time points.
Time frame: Baseline (Day 1), Week 4, and Week 24
Population: All VS and TN participants who received ≥1 dose of study intervention and have data available are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Good - Week 4 | 11 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Good - Week 24 | 5 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Very Good - Day 1 | 16 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Very Bad - Day 1 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Very Bad - Week 4 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Very Bad - Week 24 | 2 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Bad - Day 1 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Bad - Week 4 | 0 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Bad - Week 24 | 3 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Neither good or bad - Day 1 | 12 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Neither good or bad - Week 4 | 11 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Neither good or bad - Week 24 | 8 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Good - Day 1 | 9 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Very Good - Week 4 | 15 Participants |
| DOR/ISL: Virologically Suppressed Cohort | Palatability of DOR/ISL Tablet | Very Good - Week 24 | 4 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Very Good - Week 4 | 1 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Good - Week 4 | 2 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Bad - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Good - Week 24 | 1 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Good - Day 1 | 2 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Neither good or bad - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Very Bad - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Very Good - Day 1 | 1 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Very Bad - Week 4 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Neither good or bad - Week 4 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Very Bad - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Very Good - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Bad - Day 1 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Neither good or bad - Week 24 | 0 Participants |
| DOR/ISL: Treatment Naive Cohort | Palatability of DOR/ISL Tablet | Bad - Week 4 | 0 Participants |
Secondary
Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL
The percentage of TN participants with HIV-1 RNA \<50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Time frame: Week 24
Population: Participants who were TN at baseline and had data available are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Percentage of Treatment Naive (TN) Participants With HIV-1 RNA <50 Copies/mL | 100.0 percentage of participants |
Secondary
Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL
The percentage of VS participants with HIV-1 RNA ≥50 copies/mL was determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
Time frame: Week 24
Population: Participants who were VS at baseline (on stable combination antiretroviral therapy \[ART\] for ≥3 months) and had data available are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Percentage of Virologically Suppressed (VS) Participants With HIV-1 Ribonucleic Acid (RNA) ≥50 Copies/mL | 2.9 percentage of participants |
Secondary
Percentage of VS Participants With HIV-1 RNA <50 Copies/mL
The percentage of VS participants with HIV-1 RNA \<50 copies/mL will be determined at the central laboratory with an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Time frame: Week 24
Population: Participants who were VS at baseline (on stable combination ART for ≥3 months) and had data available are included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL: Virologically Suppressed Cohort | Percentage of VS Participants With HIV-1 RNA <50 Copies/mL | 94.1 percentage of participants |