HIV-1 Infection
Conditions
Brief summary
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).
Detailed description
Part 1 of this study (Day 1 to Day 7) is the double-blind period in which participants receive either ISL, DOR, DOR/ISL, or placebo. Part 2 of this study (Day 8 to Week 97) is the open-label period in which all participants receive DOR/ISL + optimized background therapy (OBT).
Interventions
DRUGISL
ISL 0.75 mg capsule taken by mouth.
DRUGDOR
DOR 100 mg tablet taken by mouth.
DRUGDOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
DRUGPlacebo to ISL
Placebo capsule matched to ISL taken by mouth.
DRUGPlacebo to DOR
Placebo tablet matched to DOR taken by mouth.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Is HIV-1 positive. * Has been receiving the same baseline ART for ≥3 months prior to signing the Informed Consent Form/Assent Form. * Weighs ≥35 kg. * Has at least triple-class resistance (must include nucleoside reverse transcriptase inhibitor \[NRTI\], non-nucleoside reverse transcriptase inhibitor \[NNRTI\], and resistance to either protease inhibitor (PI) or integrase strand transfer inhibitor (InSTI), based on central laboratory-based resistance or proviral DNA resistance testing at the Screening Visit, or historical resistance testing within 12 months of screening. * Has ≤2 fully active antiretroviral drugs remaining among all antiretroviral classes that can be effectively combined to form a viable regimen based on resistance, tolerability, safety, drug access, or acceptability to participant. * If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the first dose of study medication.
Exclusion criteria
* Has HIV type 2 (HIV-2) infection. * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. * Has hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen \[HBsAg\]-positive or HBV deoxyribonucleic acid \[DNA\] positive) and is not currently being treated for HBV. * Has a history or current evidence of any condition, therapy (including active TB co-infection), laboratory abnormality or other circumstance (including drug or alcohol abuse or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with study participation for the full study duration. * Is taking or is anticipated to require any of the prohibited therapies from the Screening Visit and throughout the study treatment period. * Is taking DOR as part of his/her current failing antiretroviral regimen. * Is taking efavirenz (EFV), etravirine, or nevirapine. * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device from the Screening Visit through the study treatment period. * Is female and is expecting to conceive or donate eggs at any time during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment | Day 1 (baseline) and Day 8 | Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL FDC or placebo were analyzed in this outcome measure. |
| Percentage of Participants With ≥1 AEs Through Week 49 | Up to 49 weeks | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25 | Up to 25 weeks | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25 | Up to 25 weeks | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49 | Up to 49 weeks | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | Day 1 (baseline) and Day 8 | Participants with a ≥0.5 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure. |
| Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment | Day 1 (baseline) and Day 8 | The change from baseline Day 1 to Day 8in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the t-distribution. The group treated with placebo were not analyzed in this outcome measure. |
| Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | Day 1 (baseline) and Day 8 | Participants receiving DOR/ISL with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure. |
| Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA | Day 1 (baseline) and Week 25 | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA | Day 1 (baseline) and Week 49 | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA | Day 1 (baseline) and Week 97 | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA | Day 8 (baseline) and Week 25 | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA | Day 8 (baseline) and Week 49 | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA | Day 8 (baseline) and Week 97 | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA | Day 1 (baseline) and Week 25 | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA | Day 1 (baseline) and Week 49 | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA | Day 1 (baseline) and Week 97 | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA | Day 8 (baseline) and Week 25 | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA | Day 8 (baseline) and Week 49 | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25 | Week 25 | The percentage of participants with HIV-1 RNA \<40 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA | Day 8 (baseline) and Week 97 | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, |
| Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group | Day 1 (baseline) and Week 25 | The change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group | Day 1 (baseline) and Week 49 | The change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group | Day 1 (baseline) and Week 97 | The change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group | Day 8 (baseline) and Week 25 | The change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group | Day 8 (baseline) and Week 49 | The change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group | Day 8 (baseline) and Week 97 | The change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 1 (baseline) and Day 8 | The percentage of participants with HIV-1 RNA \<200 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. |
| Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 1 (baseline) and Day 8 | The percentage of participants with HIV-1 RNA \<50 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. |
| Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 1 (baseline) and Day 8 | The percentage of participants with HIV-1 RNA \<40 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25 | Week 25 | The percentage of participants with HIV-1 RNA \<200 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49 | Week 49 | The percentage of participants with HIV-1 RNA \<200 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97 | Week 97 | The percentage of participants with HIV-1 RNA \<200 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25 | Week 25 | The percentage of participants with HIV-1 RNA \<50 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49 | Week 49 | The percentage of participants with HIV-1 RNA \<50 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97 | Week 97 | The percentage of participants with HIV-1 RNA \<50 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49 | Week 49 | The percentage of participants with HIV-1 RNA \<40 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. |
| Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97 | Week 97 | The percentage of participants with HIV-1 RNA \<40 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25 | Week 25 | The prevalence of viral drug resistance to DOR was based on the percentage of participants with treatment-emergent (TE) resistance-associated substitutions (RASs), which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. |
| Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49 | Week 49 | The prevalence of viral drug resistance to DOR was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. |
| Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25 | Week 25 | The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. |
| Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49 | Week 49 | The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. |
| Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25 | Week 25 | The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. |
| Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49 | Week 49 | The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. |
| Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | Week 25 | The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 25 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol, |
| Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | Week 49 | The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 49 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol, |
| Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | Week 97 | The number of participants from the pooled treatment group with treatment emergent RAS at week 97 are presented, showing the type of RAS .Analysis of the pooled treatment group was planned per protocol, |
| Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25 | Week 25 | The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25 is presented. .Analysis of the pooled treatment group was planned per protocol, |
| Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49 | Week 49 | The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49 is presented. .Analysis of the pooled treatment group was planned per protocol, |
| Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97 | Week 97 | The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97 is presented. .Analysis of the pooled treatment group was planned per protocol, |
| Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group | Day 1 (baseline) and Week 25 | The change from baseline Day 1 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group | Day 1 (baseline) and Week 49 | The change from baseline Day 1 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group | Day 1 (baseline) and Week 97 | The change from baseline Day 1 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97 | Up to 97 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. |
| Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group | Day 8 (baseline) and Week 49 | The change from baseline Day 8 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group | Day 8 (baseline) and Week 97 | The change from baseline Day 8 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group | Day 8 (baseline) and Week 25 | The change from baseline Day 8 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, |
| Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97 | Up to 97 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. |
| Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | Day 1 (baseline) and Day 8 | Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time PCR assay which has a LLOD of 40 copies/mL Only participants treated with either DOR or ISL or placebo (given with ART) were analyzed in this outcome measure. Participants treated with DOR/ISL FDC were not analyzed in this outcome measure. |
| Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment | Day 1 (baseline) and Day 8 | The change from baseline Day to Day 8 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. |
| Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | Day 1 (baseline) and Day 8 | Participants with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a LLOD of 40 copies/mL |
Countries
Australia, Canada, Chile, Colombia, France, Germany, Italy, Japan, Peru, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Heavily Treatment-Experienced (HTE) adult participants with Human Immunodeficiency Virus Type 1 (HIV-1) infection and currently on failing antiretroviral therapy (ART) were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| ISL + ART HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | 7 |
| DOR + ART HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | 14 |
| DOR/ISL + ART HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | 7 |
| Placebo + ART HTE participants with HIV-1 infection took placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | 7 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 3 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | ISL + ART | DOR + ART | DOR/ISL + ART | Placebo + ART | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46.6 Years STANDARD_DEVIATION 12.7 | 48.6 Years STANDARD_DEVIATION 11.8 | 54.0 Years STANDARD_DEVIATION 10 | 44.6 Years STANDARD_DEVIATION 9.1 | 48.5 Years STANDARD_DEVIATION 11.1 |
| Custer of differentiation 4+ (CD4+) T-cell Count | 166.3 cells/mm^3 STANDARD_DEVIATION 121.7 | 132.4 cells/mm^3 STANDARD_DEVIATION 136.6 | 178.6 cells/mm^3 STANDARD_DEVIATION 135.5 | 132.6 cells/mm^3 STANDARD_DEVIATION 100.7 | 148.5 cells/mm^3 STANDARD_DEVIATION 123.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 5 Participants | 7 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Genotypic resistance Integrase strand transfer inhibitor (InSTI )substitutions | 5 Participants | 9 Participants | 5 Participants | 6 Participants | 25 Participants |
| Genotypic resistance Non-nucleoside reverse transcriptase inhibitor (NNRTI) substitutions | 7 Participants | 14 Participants | 7 Participants | 7 Participants | 35 Participants |
| Genotypic resistance Nucleos(t)ide reverse transcriptase inhibitor (NRTI) substitutions | 7 Participants | 14 Participants | 7 Participants | 7 Participants | 35 Participants |
| Genotypic resistance Protease inhibitor (PI) substitutions | 7 Participants | 14 Participants | 7 Participants | 7 Participants | 35 Participants |
| Phenotypic resistance InSTI | 5 Participants | 9 Participants | 5 Participants | 7 Participants | 26 Participants |
| Phenotypic resistance NNRTI | 6 Participants | 13 Participants | 7 Participants | 7 Participants | 33 Participants |
| Phenotypic resistance NRTI | 7 Participants | 14 Participants | 7 Participants | 7 Participants | 35 Participants |
| Phenotypic resistance PI | 7 Participants | 12 Participants | 7 Participants | 6 Participants | 32 Participants |
| Plasma HIV-1 RNA | 4.1 Log10 copies/mL STANDARD_DEVIATION 0.8 | 4.3 Log10 copies/mL STANDARD_DEVIATION 0.9 | 4.5 Log10 copies/mL STANDARD_DEVIATION 0.8 | 4.2 Log10 copies/mL STANDARD_DEVIATION 0.7 | 4.3 Log10 copies/mL STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 0 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 7 Participants | 6 Participants | 5 Participants | 20 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 1 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 6 Participants | 6 Participants | 27 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 / 7 | 0 / 14 | 0 / 7 | 0 / 7 |
| other Total, other adverse events | 6 / 7 | 14 / 14 | 6 / 7 | 7 / 7 |
| serious Total, serious adverse events | 2 / 7 | 2 / 14 | 0 / 7 | 2 / 7 |
Outcome results
Primary
Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment
Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL FDC or placebo were analyzed in this outcome measure.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DOR/ISL + ART | Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment | 85.7 Percentage of participants |
| Placebo + ART | Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment | 0.0 Percentage of participants |
Primary
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 25 weeks
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25 | 42.9 Percentage of participants |
| DOR + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25 | 85.7 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25 | 85.7 Percentage of participants |
| Placebo + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25 | 85.7 Percentage of participants |
Primary
Percentage of Participants With ≥1 AEs Through Week 49
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 49 weeks
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants With ≥1 AEs Through Week 49 | 71.4 Percentage of participants |
| DOR + ART | Percentage of Participants With ≥1 AEs Through Week 49 | 85.7 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants With ≥1 AEs Through Week 49 | 85.7 Percentage of participants |
| Placebo + ART | Percentage of Participants With ≥1 AEs Through Week 49 | 85.7 Percentage of participants |
Primary
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 25 weeks
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25 | 0.0 Percentage of participants |
| DOR + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25 | 7.1 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25 | 14.3 Percentage of participants |
| Placebo + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25 | 0.0 Percentage of participants |
Primary
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time frame: Up to 49 weeks
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49 | 0.0 Percentage of participants |
| DOR + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49 | 14.3 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49 | 14.3 Percentage of participants |
| Placebo + ART | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49 | 0.0 Percentage of participants |
Secondary
Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group
The change from baseline Day 1 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group | 50.3 cells/mm^3 |
Secondary
Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
The change from baseline Day 1 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group | 86.9 cells/mm^3 |
Secondary
Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
The change from baseline Day 1 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group | 114.6 cells/mm^3 |
Secondary
Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group
The change from baseline Day 8 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group | 38.0 cells/mm^3 |
Secondary
Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
The change from baseline Day 8 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group | 75.1 cells/mm^3 |
Secondary
Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
The change from baseline Day 8 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group | 108.0 cells/mm^3 |
Secondary
Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment
The change from baseline Day 1 to Day 8in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the t-distribution. The group treated with placebo were not analyzed in this outcome measure.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment | -0.44 Log10 Copies/mL |
| DOR + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment | -0.96 Log10 Copies/mL |
| DOR/ISL + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment | -1.23 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment
The change from baseline Day to Day 8 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment | -0.44 Log10 Copies/mL |
| DOR + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment | -0.96 Log10 Copies/mL |
| DOR/ISL + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment | -1.23 Log10 Copies/mL |
| Placebo + ART | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment | 0.03 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
The change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group | -1.89 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
The change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group | -2.00 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
The change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group | -2.01 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
The change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group | -1.16 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
The change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group | -1.32 Log10 Copies/mL |
Secondary
Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
The change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ISL + ART | Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group | -1.36 Log10 Copies/mL |
Secondary
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25 is presented. .Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 25
Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ISL + ART | Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25 | 12 Participants |
Secondary
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49 is presented. .Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 49
Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ISL + ART | Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49 | 7 Participants |
Secondary
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97 is presented. .Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 97
Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ISL + ART | Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97 | 5 Participants |
Secondary
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49
The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 49 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 49
Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS V179I | 2 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS A98G | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS D67N | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS K103S | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS K219E | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS M184V | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS M41L | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS N348I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS V106A | 2 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS V106I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS V106M | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS F53L | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS L90M | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | RAS M36I | 1 Participants |
Secondary
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97
The number of participants from the pooled treatment group with treatment emergent RAS at week 97 are presented, showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 97
Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS D67N | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS M41L | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS N348I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS T215F | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS V106A | 2 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS V106I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS V106M | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS V179I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS F53L | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS L90M | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | RAS M36I | 1 Participants |
Secondary
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25
The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 25 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 25
Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS A98G | 2 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS D67N | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS H221Y | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS K103S | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS K219E | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS L234I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS M184V | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS M41L | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS N348I | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS V106A | 3 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS V106I | 2 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS V106M | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS V179I | 2 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS Y318F | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS F53L | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS L90M | 1 Participants |
| ISL + ART | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | RAS M36I | 1 Participants |
Secondary
Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97
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 97 weeks
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97 | 0.0 Percentage of participants |
| DOR + ART | Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97 | 21.4 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97 | 28.6 Percentage of participants |
| Placebo + ART | Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97 | 14.3 Percentage of participants |
Secondary
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL
The percentage of participants with HIV-1 RNA \<200 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 1 | 0.0 Percentage of participants |
| ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 8 | 0.0 Percentage of participants |
| DOR + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 8 | 14.3 Percentage of participants |
| DOR + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 1 | 0.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 1 | 0.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 8 | 14.3 Percentage of participants |
| Placebo + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 1 | 0.0 Percentage of participants |
| Placebo + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | Day 8 | 0.0 Percentage of participants |
Secondary
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL
The percentage of participants with HIV-1 RNA \<40 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 1 | 0.0 Percentage of participants |
| ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 8 | 0.0 Percentage of participants |
| DOR + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 8 | 14.3 Percentage of participants |
| DOR + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 1 | 0.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 1 | 0.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 8 | 0.0 Percentage of participants |
| Placebo + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 1 | 0.0 Percentage of participants |
| Placebo + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | Day 8 | 0.0 Percentage of participants |
Secondary
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL
The percentage of participants with HIV-1 RNA \<50 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 1 | 0.0 Percentage of participants |
| ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 8 | 0.0 Percentage of participants |
| DOR + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 8 | 14.3 Percentage of participants |
| DOR + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 1 | 0.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 1 | 0.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 8 | 0.0 Percentage of participants |
| Placebo + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 1 | 0.0 Percentage of participants |
| Placebo + ART | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | Day 8 | 0.0 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA | 85.3 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA | 80.6 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA | 84.6 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA | 64.7 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA | 67.7 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA | 69.2 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA | 67.6 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA | 71.0 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 1 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA | 73.1 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA | 58.8 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA | 61.3 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
Time frame: Day 8 (baseline) and Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA | 61.5 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25
The percentage of participants with HIV-1 RNA \<200 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25 | 64.7 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49
The percentage of participants with HIV-1 RNA \<200 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49 | 77.4 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97
The percentage of participants with HIV-1 RNA \<200 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97 | 80.8 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25
The percentage of participants with HIV-1 RNA \<40 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25 | 58.8 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49
The percentage of participants with HIV-1 RNA \<40 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49 | 71.0 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97
The percentage of participants with HIV-1 RNA \<40 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97 | 69.2 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25
The percentage of participants with HIV-1 RNA \<50 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25 | 58.8 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49
The percentage of participants with HIV-1 RNA \<50 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49 | 71.0 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97
The percentage of participants with HIV-1 RNA \<50 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
Time frame: Week 97
Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97 | 69.2 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25
The prevalence of viral drug resistance to DOR was based on the percentage of participants with treatment-emergent (TE) resistance-associated substitutions (RASs), which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25 | 33.3 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49
The prevalence of viral drug resistance to DOR was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49 | 28.6 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25
The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25 | 8.3 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49
The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49 | 14.3 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49
The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 49
Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49 | 28.6 Percentage of participants |
Secondary
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25
The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Time frame: Week 25
Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25 | 25.0 Percentage of participants |
Secondary
Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
Participants with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a LLOD of 40 copies/mL
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 14.3 Percentage of participants |
| DOR + ART | Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 50.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 85.7 Percentage of participants |
| Placebo + ART | Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 0.0 Percentage of participants |
Secondary
Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
Participants with a ≥0.5 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | 28.6 Percentage of participants |
| DOR + ART | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | 78.6 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | 85.7 Percentage of participants |
Secondary
Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
Participants receiving DOR/ISL with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | 14.3 Percentage of participants |
| DOR + ART | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | 50.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | 85.7 Percentage of participants |
Secondary
Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time PCR assay which has a LLOD of 40 copies/mL Only participants treated with either DOR or ISL or placebo (given with ART) were analyzed in this outcome measure. Participants treated with DOR/ISL FDC were not analyzed in this outcome measure.
Time frame: Day 1 (baseline) and Day 8
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 28.6 Percentage of participants |
| DOR + ART | Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 78.6 Percentage of participants |
| Placebo + ART | Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | 0.0 Percentage of participants |
Secondary
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97
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 97 weeks
Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ISL + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97 | 85.7 Percentage of participants |
| DOR + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97 | 100.0 Percentage of participants |
| DOR/ISL + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97 | 85.7 Percentage of participants |
| Placebo + ART | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97 | 100.0 Percentage of participants |