HIV Infection
Conditions
Brief summary
This study will evaluate the safety and efficacy of a switch to Doravirine/Islatravir (DOR/ISL) (MK-8591A) (a fixed dose combination of doravirine 100 mg and islatravir 0.75 mg) in participants living with human immunodeficiency virus-1 (HIV-1) virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to DOR/ISL (MK-8591A) will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.
Interventions
DRUGDOR/ISL
100 mg DOR/ 0.75 ISL FDC single tablet taken orally once daily
DRUGBIC/FTC/TAF
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
DRUGPlacebo to FDC DOR/ISL
Placebo to FDC DOR/ISL in a single tablet taken orally, once daily
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA \<50 copies/mL at screening. * Has been receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen. * Females are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Exclusion criteria
* Has HIV-2 infection. * Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection. * Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma. * Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies. * Is currently participating in or has participated in a 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 doravirine (DOR). * expects to conceive or donate eggs at any time during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48 | Week 48 | The Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the primary outcome measure, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit. |
| Percentage of Participants With One or More Adverse Events (AEs) up to Week 48 | Up to 48 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented. |
| Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48 | Up to 48 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96 | Week 96 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96, is presented using the Food and Drug Administration (FDA) Snapshot missing data approach. The percentage values were rounded to the nearest tenth digit. |
| Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144 | Week 144 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | Week 48 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit. |
| Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 | Week 48 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 48, is presented using the FDA snapshot missing data approach. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | Week 96 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 96, is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit. |
| Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 96 | Week 96 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<40 copies/mL at Week 96, is presented using the FDA snapshot missing data approach. |
| Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144 | Week 144 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, the percentage of participants with HIV-1 RNA \<50 copies/mL at Week 144 is presented using the FDA snapshot missing data approach. The percentage values were rounded to the nearest tenth digit. |
| Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 144 | Week 144 | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. Per protocol, the secondary outcome measure, percentage of participants with HIV-1 RNA \<40 copies/mL at Week 144, is presented using the FDA snapshot missing data approach. |
| Mean Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48 | Baseline and Week 48 | Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and 48 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline. |
| Mean Change From Baseline in CD4+ T-cell Count at Week 96 | Baseline and Week 96 | Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and 96 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline. |
| Mean Change From Baseline in CD4+ T-cell Count at Week 144 | Baseline and Week 144 | Plasma CD4+ T-cell count was measured in cells/mm\^3 for baseline and 144 weeks by a central laboratory. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. The mean change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline. |
| Number of Participants With Viral Drug Resistance-associated Substitutions at Week 48 | Week 48 | Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented. |
| Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96 | Week 96 | Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 96 is presented. |
| Number of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144 | Week 144 | Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at week 144 is presented. |
| Change From Baseline in Body Weight at Week 48 | Baseline and Week 48 | Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented. |
| Change From Baseline in Body Weight at Week 96 | Baseline and Week 96 | Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 96 is presented. |
| Change From Baseline in Body Weight at Week 144 | Baseline and Week 144 | Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 144 is presented. |
| Percentage of Participants With One or More AEs | Up to approximately 55 months | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced at least one or more AEs is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. |
| Percentage of Participants Who Discontinued Study Intervention Due to an AE | Up to approximately 40 months | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE is presented. Per protocol, pregnancy-related AEs collected for enrolled participants are reported separately and are presented in the AE module. |
Countries
Australia, Austria, Canada, Finland, France, Germany, Italy, Japan, Puerto Rico, Spain, United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Participant flow
Recruitment details
Adult participants living with human immunodeficiency virus-1 (HIV-1) who have been virologically suppressed for ≥3 months and receiving bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) with no history of treatment failure were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| DOR/ISL An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 322 |
| BIC/FTC/TAF 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. | 321 |
| Total | 643 |
Baseline characteristics
| Characteristic | BIC/FTC/TAF | Total | DOR/ISL |
|---|---|---|---|
| Age, Continuous | 48.0 Years STANDARD_DEVIATION 11.8 | 47.8 Years STANDARD_DEVIATION 12.2 | 47.6 Years STANDARD_DEVIATION 12.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 55 Participants | 119 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants | 517 Participants | 256 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 27 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 115 Participants | 59 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 240 Participants | 479 Participants | 239 Participants |
| Sex: Female, Male Female | 78 Participants | 183 Participants | 105 Participants |
| Sex: Female, Male Male | 243 Participants | 460 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 322 | 2 / 305 | 0 / 266 | 0 / 321 | 0 / 301 | 0 / 281 | 0 / 132 | 0 / 131 | 0 / 196 | 0 / 152 |
| other Total, other adverse events | 85 / 322 | 104 / 305 | 151 / 266 | 93 / 319 | 86 / 301 | 101 / 281 | 34 / 132 | 13 / 131 | 14 / 196 | 0 / 152 |
| serious Total, serious adverse events | 14 / 322 | 19 / 305 | 7 / 266 | 16 / 319 | 11 / 301 | 6 / 281 | 0 / 132 | 1 / 131 | 3 / 196 | 0 / 152 |
Outcome results
Primary
Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
Time frame: Week 48
Population: All participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL | Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48 | 0.6 Percentage of Participants |
| BIC/FTC/TAF | Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48 | 0.3 Percentage of Participants |
p-value: <0.00195% CI: [-1.19, 1.96]Unstratified Miettinen and Nurminen
Primary
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
Time frame: Up to 48 weeks
Population: All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL | Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48 | 2.5 Percentage of Participants |
| BIC/FTC/TAF | Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48 | 2.5 Percentage of Participants |
95% CI: [-2.7, 2.6]
Primary
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
Time frame: Up to 48 weeks
Population: All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL | Percentage of Participants With One or More Adverse Events (AEs) up to Week 48 | 71.1 Percentage of Participants |
| BIC/FTC/TAF | Percentage of Participants With One or More Adverse Events (AEs) up to Week 48 | 74.6 Percentage of Participants |
95% CI: [-10.4, 3.4]
Secondary
Change From Baseline in Body Weight at Week 144
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement.
Time frame: Baseline and Week 144
Secondary
Change From Baseline in Body Weight at Week 48
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
Time frame: Baseline and Week 48
Population: Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result in the specified analysis window.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DOR/ISL | Change From Baseline in Body Weight at Week 48 | 0.23 kilogram (kg) | Standard Deviation 4.19 |
| BIC/FTC/TAF | Change From Baseline in Body Weight at Week 48 | 0.55 kilogram (kg) | Standard Deviation 4.4 |
p-value: 0.39295% CI: [-0.99, 0.39]ANCOVA
Secondary
Change From Baseline in Body Weight at Week 96
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement.
Time frame: Baseline and Week 96
Secondary
Change From Baseline in CD4+ T-cell Count at Week 144
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Time frame: Baseline and Week 144
Secondary
Change From Baseline in CD4+ T-cell Count at Week 96
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Time frame: Baseline and Week 96
Secondary
Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
Time frame: Baseline and Week 48
Population: All participants who received ≥1 dose of study intervention and who had baseline data for CD4+ T-cell count. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DOR/ISL | Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48 | -19.66 cells/mm^3 |
| BIC/FTC/TAF | Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48 | 40.51 cells/mm^3 |
Secondary
Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Time frame: Week 144
Secondary
Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Time frame: Week 96
Secondary
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<40 or \<50 copies/mL at Week 144 is presented.
Time frame: Week 144
Secondary
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<40 or \<50 copies/mL at Week 96 is presented.
Time frame: Week 96
Secondary
Participants With HIV-1 RNA ≥50 Copies/mL at Week 144
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented.
Time frame: Week 144
Secondary
Participants With HIV-1 RNA ≥50 Copies/mL at Week 96
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented.
Time frame: Week 96
Secondary
Participants With Viral Drug Resistance-associated Substitutions at Week 48
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
Time frame: Week 48
Population: Participants who met the definition of confirmed virologic rebound (two consecutive \[2 to 4 weeks apart\] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DOR/ISL | Participants With Viral Drug Resistance-associated Substitutions at Week 48 | 0 Participants |
Secondary
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 144
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to Week 144
Secondary
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<40 copies/mL at Week 48 is presented using the FDA snapshot missing data approach.
Time frame: Week 48
Population: All participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL | Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 | 93.2 Percentage of Participants |
| BIC/FTC/TAF | Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 | 94.0 Percentage of Participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA \<50 copies/mL at Week 48 is presented using the FDA snapshot missing data approach
Time frame: Week 48
Population: All participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | 93.8 Percentage of Participants |
| BIC/FTC/TAF | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | 94.4 Percentage of Participants |
Secondary
Percentage of Participants With One or More AEs up to Week 144
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to Week 144