Clinical Trials List
Protocol NumberMK-8591A-020
NCT Number(ClinicalTrials.gov Identfier)NCT04233879
Completed
2021-03-01 - 2028-03-31
Phase III
Not yet recruiting2
Recruiting1
ICD-10B20
Human immunodeficiency virus [HIV] disease
ICD-9042
Human immunodeficiency virus（HIV）infection disease
A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 蔡宏津 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- HSIN-YUN SUN Division of General Internal Medicine
- Tiffany Ting-Fang Shih Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Nan-Yao Lee Division of General Internal Medicine
- 羅景霳 Division of General Internal Medicine
- 李佳雯 Division of General Internal Medicine
- 薛伶珊 Division of General Internal Medicine
- Po-Lin Chen Division of General Internal Medicine
- 李明吉 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
HIV-1 Infection
Objectives
To evaluate the antiretroviral activity of DOR/ISL compared to BIC/FTC/TAF as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48
To evaluate the safety and tolerabilityof DOR/ISL compared to BIC/FTC/TAF as assessed by review of the accumulated safety data through Weeks 48 and96
Test Drug
MK-8591A [Doravirine (MK-1439) + Islatravir (MK-8591)]BiktarvyR
Active Ingredient
Doravirine (MK-1439) + Islatravir (MK-8591)
Bictegravir sodium, Emtricitabine, Tenofovir alafenamide fumarate
Bictegravir sodium, Emtricitabine, Tenofovir alafenamide fumarate
Dosage Form
tablet
tablet
tablet
Dosage
Doravirine 100 mg/ Islatravir 0.75 mg
50/200/25 mg
50/200/25 mg
Endpoints
Primary Outcome Measures :
Percentage of participants with HIV-1 RNA <50 copies/mL [ Time Frame: Week 48 ]
The percentage of participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
Percentage of participants experiencing ≥1 adverse events (AEs) [ Time Frame: Up to 98 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 interventions.
Percentage of participants discontinuing from study treatment due to AE(s) [ Time Frame: Up to 96 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 interventions.
Percentage of participants with HIV-1 RNA <50 copies/mL [ Time Frame: Week 48 ]
The percentage of participants with HIV-1 RNA <50 copies/mL will be determined at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay with a lower limit of detection (LLOD) of 40 copies/mL.
Percentage of participants experiencing ≥1 adverse events (AEs) [ Time Frame: Up to 98 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 interventions.
Percentage of participants discontinuing from study treatment due to AE(s) [ Time Frame: Up to 96 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 interventions.
Inclution Criteria
Inclusion Criteria:
Is HIV-1 positive
Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required
Is HIV-1 positive
Is naïve to antiretroviral therapy (ART) defined as having received ≤10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection including prevention of mother-to-child transmission up to 1 month prior to screening.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); 2) Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis); 3) A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; 4) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required
Exclusion Criteria
Exclusion Criteria:
Has HIV-2 infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive)
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period
Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention
Has exclusionary laboratory values within 45 days prior to Day 1
Is female and is expecting to conceive or donate eggs at any time during the study
Has HIV-2 infection
Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause, including active HBV infection (defined as hepatitis B surface antigen [HBsAg]-positive or hepatitis B virus deoxyribonucleic acid [HBV DNA]-positive)
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma
Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study
Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapy from 45 days prior to Day 1 through the study intervention period
Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study intervention period
Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, or any study intervention
Has exclusionary laboratory values within 45 days prior to Day 1
Is female and is expecting to conceive or donate eggs at any time during the study
The Estimated Number of Participants
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Taiwan
12 participants
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Global
680 participants
