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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04233216




Registration number
NCT04233216
Ethics application status
Date submitted
15/01/2020
Date registered
18/01/2020
Date last updated
20/11/2020

Titles & IDs
Public title
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
Scientific 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
Secondary ID [1] 0 0
MK-8591A-019
Secondary ID [2] 0 0
8591A-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ISL
Treatment: Drugs - DOR
Treatment: Drugs - DOR/ISL
Treatment: Drugs - Placebo to ISL
Treatment: Drugs - Placebo to DOR

Experimental: Part 1, Group 1: ISL + ART - HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7 in Part 1.

Experimental: Part 1, Group 2: DOR + ART - HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7 in Part 1.

Experimental: Part 1, Group 3: DOR/ISL + ART - HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7 in Part 1.

Placebo Comparator: Part 1, Group 4: Placebo + ART - HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7 in Part 1.

Experimental: Part 2, Group 5: Open-Label DOR/ISL + OBT - HTE participants from Groups 1 to 4 with HIV-1 infection take open-label 100 mg DOR/0.75 mg ISL + OBT in Part 2 (Day 8 to Week 97).


Treatment: Drugs: ISL
ISL 0.75 mg capsule taken by mouth.

Treatment: Drugs: DOR
DOR 100 mg tablet taken by mouth.

Treatment: Drugs: DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.

Treatment: Drugs: Placebo to ISL
Placebo capsule matched to ISL taken by mouth.

Treatment: Drugs: Placebo to DOR
Placebo tablet matched to DOR taken by mouth.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants receiving doravirine/islatravir (DOR/ISL) with =0.5 log10 decrease from baseline in human immunodificiency virus type 1 (HIV-1) ribonucleic acid (RNA) compared to placebo treatment - The change from baseline in HIV-1 RNA 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.
Timepoint [1] 0 0
Day 1 (baseline) and Day 8
Primary outcome [2] 0 0
Percentage of participants with =1 adverse events (AEs) - 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.
Timepoint [2] 0 0
Up to 49 weeks
Primary outcome [3] 0 0
Percentage of participants withdrawing from study treatment due to AE(s) - 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.
Timepoint [3] 0 0
Up to 49 weeks
Secondary outcome [1] 0 0
Percentage of participants with =1 adverse events (AEs) - 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.
Timepoint [1] 0 0
Up to 97 weeks
Secondary outcome [2] 0 0
Percentage of participants discontinuing from study therapy due to AE(s) - 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.
Timepoint [2] 0 0
Up to 97 weeks
Secondary outcome [3] 0 0
Percentage of participants receiving DOR or ISL (given with antiretoviral therapy [ART]) with =0.5 log10 decrease in HIV-1 RNA compared to placebo treatment - The percentage of participants with =0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [3] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [4] 0 0
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART), DOR, or ISL compared to placebo treatment - The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [4] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [5] 0 0
Percentage of participants receiving DOR/ISL (given with ART), DOR, or ISL with =1.0 log10 decrease from baseline in HIV-1 RNA compared to placebo treatment - The percentage of participants with =1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [5] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [6] 0 0
Percentage of participants receiving DOR/ISL (given with ART) with =0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [6] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [7] 0 0
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) compared to DOR or ISL treatment - The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [7] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [8] 0 0
Percentage of participants receiving DOR/ISL (given with ART) with =1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [8] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [9] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with =0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [9] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [10] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with =0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [10] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [11] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with =0.5 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =0.5 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [11] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [12] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with =1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [12] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [13] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with =1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [13] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [14] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with =1.0 log10 decrease from baseline in HIV-1 RNA compared to DOR or ISL treatment - The percentage of participants with =1.0 log10 change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [14] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [15] 0 0
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT - The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [15] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [16] 0 0
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT - The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [16] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [17] 0 0
Mean change from baseline in HIV-1 RNA following treatment with DOR/ISL (given with ART) + OBT - The mean change from baseline in HIV-1 RNA will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [17] 0 0
Day 8 (baseline) and Week 97
Secondary outcome [18] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL - The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [18] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [19] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL - The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [19] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [20] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <200 copies mL - The percentage of participants with HIV-1 RNA <200 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [20] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [21] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL - The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [21] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [22] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL - The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [22] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [23] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <50 copies mL - The percentage of participants with HIV-1 RNA <50 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [23] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [24] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL - The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [24] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [25] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL - The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [25] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [26] 0 0
Percentage of participants receiving DOR/ISL (given with ART) + OBT with HIV-1 RNA <40 copies mL - The percentage of participants with HIV-1 RNA <40 copies mL will be determined. The central laboratory will measure plasma HIV-1 RNA using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL.
Timepoint [26] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [27] 0 0
Prevalence of viral drug resistance to DOR - The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
Timepoint [27] 0 0
Week 25
Secondary outcome [28] 0 0
Prevalence of viral drug resistance to DOR - The prevalence of viral drug resistance to DOR will be determined. Viral resistance testing will be performed by the central laboratory.
Timepoint [28] 0 0
Week 49
Secondary outcome [29] 0 0
Prevalence of viral drug resistance to ISL - The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
Timepoint [29] 0 0
Week 25
Secondary outcome [30] 0 0
Prevalence of viral drug resistance to ISL - The prevalence of viral drug resistance to ISL will be determined. Viral resistance testing will be performed by the central laboratory.
Timepoint [30] 0 0
Week 49
Secondary outcome [31] 0 0
Prevalence of viral drug resistance to optimized background therapy (OBT) components - The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
Timepoint [31] 0 0
Week 25
Secondary outcome [32] 0 0
Prevalence of viral drug resistance to OBT components - The prevalence of viral drug resistance to OBT components will be determined. Viral resistance testing will be performed by the central laboratory.
Timepoint [32] 0 0
Week 49
Secondary outcome [33] 0 0
Role of baseline antiviral resistance on viral resistance-associated substitutions (RASs) - The role of baseline antiviral resistance on viral RAS will be determined.
Timepoint [33] 0 0
Day 1 (baseline) and Week 25
Secondary outcome [34] 0 0
Role of baseline antiviral resistance on viral RASs - The role of baseline antiviral resistance on viral RAS will be determined.
Timepoint [34] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [35] 0 0
Role of baseline antiviral resistance on viral RASs - The role of baseline antiviral resistance on viral RAS will be determined.
Timepoint [35] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [36] 0 0
Role of baseline antiviral resistance on HIV-1 RNA - The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Timepoint [36] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [37] 0 0
Role of baseline antiviral resistance on HIV-1 RNA - The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Timepoint [37] 0 0
Day 8 (baseline) and Week 49
Secondary outcome [38] 0 0
Role of baseline antiviral resistance on HIV-1 RNA - The role of baseline antiviral resistance on HIV-1 RNA will be determined.
Timepoint [38] 0 0
Day 8 (baseline) and Week 97
Secondary outcome [39] 0 0
Change from baseline in cluster of differentiation 4+ (CD4+) T-cell counts - The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Timepoint [39] 0 0
Day 1 (baseline) and Week 25
Secondary outcome [40] 0 0
Change from baseline in CD4+ T-cell counts - The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Timepoint [40] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [41] 0 0
Change from baseline in CD4+ T-cell counts - The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Timepoint [41] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [42] 0 0
Change from baseline in CD4+ T-cell counts - The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Timepoint [42] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [43] 0 0
Change from baseline in CD4+ T-cell counts - The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Timepoint [43] 0 0
Day 8 (baseline) and Week 49
Secondary outcome [44] 0 0
Change from baseline in CD4+ T-cell counts - The change from baseline in CD4+ T-cell counts will be determined. CD4+ T-cell counts will be determined by the central laboratory.
Timepoint [44] 0 0
Day 8 (baseline) and Week 97

Eligibility
Key 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 (nucleoside reverse transcriptase inhibitor
[NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and resistance to at
least 1 other class [i.e., resistance to at least 1 drug in each class]) based on
resistance testing at the Screening Visit.

- Has =1 fully active antiretroviral remaining 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.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital ( Site 5309) - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice ( Site 5300) - Sydney
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Brisbane ( Site 5312) - Brisbane
Recruitment hospital [4] 0 0
The Alfred Hospital ( Site 5304) - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Chile
State/province [17] 0 0
Araucania
Country [18] 0 0
Chile
State/province [18] 0 0
Region M. De Santiago
Country [19] 0 0
Colombia
State/province [19] 0 0
Valle Del Cauca
Country [20] 0 0
France
State/province [20] 0 0
Ain
Country [21] 0 0
France
State/province [21] 0 0
Alpes-Maritimes
Country [22] 0 0
France
State/province [22] 0 0
Bouches-du-Rhone
Country [23] 0 0
France
State/province [23] 0 0
Gironde
Country [24] 0 0
France
State/province [24] 0 0
Herault
Country [25] 0 0
France
State/province [25] 0 0
Nord
Country [26] 0 0
France
State/province [26] 0 0
Seine-Maritime
Country [27] 0 0
France
State/province [27] 0 0
Seine-Saint-Denis
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
Germany
State/province [29] 0 0
Niedersachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-Westfalen
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Hamburg
Country [33] 0 0
Italy
State/province [33] 0 0
Monza E Brianza
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Italy
State/province [35] 0 0
Modena
Country [36] 0 0
Italy
State/province [36] 0 0
Roma
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
Korea, Republic of
State/province [38] 0 0
Pusan-Kwangyokshi
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Seoul
Country [40] 0 0
Peru
State/province [40] 0 0
Lima
Country [41] 0 0
Portugal
State/province [41] 0 0
Braga
Country [42] 0 0
Portugal
State/province [42] 0 0
Porto
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Leningradskaya Oblast
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Moskva
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Samarskaya Oblast
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Sankt-Peterburg
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Smolenskaya Oblast
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Sverdlovskaya Oblast
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Tatarstan, Respublika
Country [50] 0 0
South Africa
State/province [50] 0 0
Kwazulu-Natal
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Murcia
Country [53] 0 0
Spain
State/province [53] 0 0
Madrid
Country [54] 0 0
Ukraine
State/province [54] 0 0
Dnipropetrovska Oblast
Country [55] 0 0
Ukraine
State/province [55] 0 0
Kharkivska Oblast
Country [56] 0 0
Ukraine
State/province [56] 0 0
Khersonska Oblast
Country [57] 0 0
Ukraine
State/province [57] 0 0
Kyivska Oblast
Country [58] 0 0
Ukraine
State/province [58] 0 0
Mykolaivska Oblast
Country [59] 0 0
Ukraine
State/province [59] 0 0
Odeska Oblast
Country [60] 0 0
Ukraine
State/province [60] 0 0
Vinnytska Oblast
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Camden

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Merck Sharp & Dohme Corp.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04233216
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme Corp.
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Contact person for public queries
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Toll Free Number
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1-888-577-8839
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Trialsites@merck.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04233216