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NCT Number: NCT04233216

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

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).

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Key information

Conditions

HIV-1 Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Holdsworth House Medical Practice ( Site 5300), Sydney, New South Wales, Australia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ISL

Drug

ISL 0.75 mg capsule taken by mouth.

Other names: Islatravir, MK-8591

DOR

Drug

DOR 100 mg tablet taken by mouth.

Other names: Doravirine, MK-1439

DOR/ISL

Drug

100 mg DOR/0.75 mg ISL FDC taken by mouth.

Other names: Doravirine/Islatravir, MK-8591A

Placebo to ISL

Drug

Placebo capsule matched to ISL taken by mouth.

Placebo to DOR

Drug

Placebo tablet matched to DOR taken by mouth.

Primary outcomes

  1. 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

    Time frame: 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.

  2. Percentage of Participants With ≥1 AEs Through Week 49

    Time frame: 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.

  3. Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25

    Time frame: 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.

  4. Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25

    Time frame: 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.

  5. Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49

    Time frame: 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 outcomes

  1. Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97

    Time frame: 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.

  2. Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. 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

    Time frame: 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.

  5. 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

    Time frame: 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

  6. 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

    Time frame: 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.

  7. 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

    Time frame: 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.

  8. 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

    Time frame: 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.

  9. Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA

    Time frame: 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,

  10. Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA

    Time frame: 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,

  11. Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA

    Time frame: 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,

  12. Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA

    Time frame: 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,

  13. Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA

    Time frame: 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,

  14. Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA

    Time frame: 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,

  15. Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA

    Time frame: 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,

  16. Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA

    Time frame: 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,

  17. Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA

    Time frame: 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,

  18. Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA

    Time frame: 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,

  19. Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA

    Time frame: 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,

  20. Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA

    Time frame: 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,

  21. Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group

    Time frame: 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,

  22. Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group

    Time frame: 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,

  23. Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group

    Time frame: 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,

  24. Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group

    Time frame: 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,

  25. Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group

    Time frame: 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,

  26. Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group

    Time frame: 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,

  27. Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL

    Time frame: 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.

  28. Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL

    Time frame: 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.

  29. Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL

    Time frame: 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.

  30. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25

    Time frame: 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,

  31. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49

    Time frame: 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,

  32. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97

    Time frame: 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,

  33. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25

    Time frame: 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,

  34. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49

    Time frame: 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,

  35. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97

    Time frame: 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,

  36. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25

    Time frame: 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,

  37. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49

    Time frame: 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.

  38. Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97

    Time frame: 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,

  39. Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25

    Time frame: 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.

  40. Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49

    Time frame: 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.

  41. Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25

    Time frame: 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.

  42. Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49

    Time frame: 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.

  43. Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25

    Time frame: 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.

  44. Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49

    Time frame: 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.

  45. Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25

    Time frame: 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,

  46. Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49

    Time frame: 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,

  47. Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97

    Time frame: 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,

  48. Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25

    Time frame: 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,

  49. Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49

    Time frame: 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,

  50. Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97

    Time frame: 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,

  51. Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group

    Time frame: 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,

  52. Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group

    Time frame: 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,

  53. Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group

    Time frame: 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,

  54. Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group

    Time frame: 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,

  55. Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group

    Time frame: 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,

  56. Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group

    Time frame: 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,

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Jan 18, 2020
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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