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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04233216
Ethics application status
Date submitted
15/01/2020
Date registered
18/01/2020

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
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

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: 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; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97.

Experimental: DOR + ART - HTE participants with HIV-1 infection take 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.

Experimental: 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; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.

Placebo comparator: Placebo + ART - HTE participants with HIV-1 infection take 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.


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 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment
Timepoint [1] 0 0
Day 1 (baseline) and Day 8
Primary outcome [2] 0 0
Percentage of Participants With =1 AEs Through Week 49
Timepoint [2] 0 0
Up to 49 weeks
Primary outcome [3] 0 0
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25
Timepoint [3] 0 0
Up to 25 weeks
Primary outcome [4] 0 0
Percentage of Participants With =1 Adverse Events (AEs) Through Week 25
Timepoint [4] 0 0
Up to 25 weeks
Primary outcome [5] 0 0
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49
Timepoint [5] 0 0
Up to 49 weeks
Secondary outcome [1] 0 0
Percentage of Participants With =1 Adverse Events (AEs) Through Week 97
Timepoint [1] 0 0
Up to 97 weeks
Secondary outcome [2] 0 0
Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97
Timepoint [2] 0 0
Up to 97 weeks
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [4] 0 0
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
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 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
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 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
Timepoint [6] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [7] 0 0
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
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 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
Timepoint [8] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [9] 0 0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
Timepoint [9] 0 0
Day 1 (baseline) and Week 25
Secondary outcome [10] 0 0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
Timepoint [10] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [11] 0 0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
Timepoint [11] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [12] 0 0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
Timepoint [12] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [13] 0 0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
Timepoint [13] 0 0
Day 8 (baseline) and Week 49
Secondary outcome [14] 0 0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
Timepoint [14] 0 0
Day 8 (baseline) and Week 97
Secondary outcome [15] 0 0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
Timepoint [15] 0 0
Day 1 (baseline) and Week 25
Secondary outcome [16] 0 0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
Timepoint [16] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [17] 0 0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
Timepoint [17] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [18] 0 0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
Timepoint [18] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [19] 0 0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
Timepoint [19] 0 0
Day 8 (baseline) and Week 49
Secondary outcome [20] 0 0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
Timepoint [20] 0 0
Day 8 (baseline) and Week 97
Secondary outcome [21] 0 0
Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
Timepoint [21] 0 0
Day 1 (baseline) and Week 25
Secondary outcome [22] 0 0
Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
Timepoint [22] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [23] 0 0
Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
Timepoint [23] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [24] 0 0
Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
Timepoint [24] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [25] 0 0
Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
Timepoint [25] 0 0
Day 8 (baseline) and Week 49
Secondary outcome [26] 0 0
Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
Timepoint [26] 0 0
Day 8 (baseline) and Week 97
Secondary outcome [27] 0 0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL
Timepoint [27] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [28] 0 0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL
Timepoint [28] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [29] 0 0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL
Timepoint [29] 0 0
Day 1 (baseline) and Day 8
Secondary outcome [30] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25
Timepoint [30] 0 0
Week 25
Secondary outcome [31] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49
Timepoint [31] 0 0
Week 49
Secondary outcome [32] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97
Timepoint [32] 0 0
Week 97
Secondary outcome [33] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25
Timepoint [33] 0 0
Week 25
Secondary outcome [34] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49
Timepoint [34] 0 0
Week 49
Secondary outcome [35] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97
Timepoint [35] 0 0
Week 97
Secondary outcome [36] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25
Timepoint [36] 0 0
Week 25
Secondary outcome [37] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49
Timepoint [37] 0 0
Week 49
Secondary outcome [38] 0 0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97
Timepoint [38] 0 0
Week 97
Secondary outcome [39] 0 0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25
Timepoint [39] 0 0
Week 25
Secondary outcome [40] 0 0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49
Timepoint [40] 0 0
Week 49
Secondary outcome [41] 0 0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25
Timepoint [41] 0 0
Week 25
Secondary outcome [42] 0 0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49
Timepoint [42] 0 0
Week 49
Secondary outcome [43] 0 0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25
Timepoint [43] 0 0
Week 25
Secondary outcome [44] 0 0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49
Timepoint [44] 0 0
Week 49
Secondary outcome [45] 0 0
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25
Timepoint [45] 0 0
Week 25
Secondary outcome [46] 0 0
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49
Timepoint [46] 0 0
Week 49
Secondary outcome [47] 0 0
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97
Timepoint [47] 0 0
Week 97
Secondary outcome [48] 0 0
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA =200 Copies/mL at Week 25
Timepoint [48] 0 0
Week 25
Secondary outcome [49] 0 0
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA =200 Copies/mL at Week 49
Timepoint [49] 0 0
Week 49
Secondary outcome [50] 0 0
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA =200 Copies/mL at Week 97
Timepoint [50] 0 0
Week 97
Secondary outcome [51] 0 0
Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group
Timepoint [51] 0 0
Day 1 (baseline) and Week 25
Secondary outcome [52] 0 0
Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Timepoint [52] 0 0
Day 1 (baseline) and Week 49
Secondary outcome [53] 0 0
Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
Timepoint [53] 0 0
Day 1 (baseline) and Week 97
Secondary outcome [54] 0 0
Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group
Timepoint [54] 0 0
Day 8 (baseline) and Week 25
Secondary outcome [55] 0 0
Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Timepoint [55] 0 0
Day 8 (baseline) and Week 49
Secondary outcome [56] 0 0
Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
Timepoint [56] 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 (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.
Minimum age
No limit
Maximum age
No limit
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2023
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice ( Site 5300) - Sydney
Recruitment hospital [2] 0 0
St Vincent's Hospital ( Site 5309) - Sydney
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Brisbane ( Site 5312) - Brisbane
Recruitment hospital [4] 0 0
Monash Health-Monash Medical Centre ( Site 5313) - Clayton
Recruitment hospital [5] 0 0
The Alfred Hospital ( Site 5304) - Melbourne
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 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
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Chile
State/province [18] 0 0
Araucania
Country [19] 0 0
Chile
State/province [19] 0 0
Region M. De Santiago
Country [20] 0 0
Colombia
State/province [20] 0 0
Distrito Capital De Bogota
Country [21] 0 0
Colombia
State/province [21] 0 0
Valle Del Cauca
Country [22] 0 0
France
State/province [22] 0 0
Ain
Country [23] 0 0
France
State/province [23] 0 0
Alpes-Maritimes
Country [24] 0 0
France
State/province [24] 0 0
Bouches-du-Rhone
Country [25] 0 0
France
State/province [25] 0 0
Gironde
Country [26] 0 0
France
State/province [26] 0 0
Haute-Normandie
Country [27] 0 0
France
State/province [27] 0 0
Herault
Country [28] 0 0
France
State/province [28] 0 0
Nord
Country [29] 0 0
France
State/province [29] 0 0
Seine-Saint-Denis
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
Germany
State/province [31] 0 0
Niedersachsen
Country [32] 0 0
Germany
State/province [32] 0 0
Nordrhein-Westfalen
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Hamburg
Country [35] 0 0
Italy
State/province [35] 0 0
Emilia-Romagna
Country [36] 0 0
Italy
State/province [36] 0 0
Monza E Brianza
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Pavia
Country [39] 0 0
Italy
State/province [39] 0 0
Roma
Country [40] 0 0
Japan
State/province [40] 0 0
Tokyo
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Pusan-Kwangyokshi
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
Peru
State/province [43] 0 0
Muni Metro De Lima
Country [44] 0 0
Peru
State/province [44] 0 0
Lima
Country [45] 0 0
Portugal
State/province [45] 0 0
Braga
Country [46] 0 0
Portugal
State/province [46] 0 0
Lisboa
Country [47] 0 0
Portugal
State/province [47] 0 0
Porto
Country [48] 0 0
Puerto Rico
State/province [48] 0 0
San Juan
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Leningradskaya Oblast
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Moskva
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Samarskaya Oblast
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Sankt-Peterburg
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Smolenskaya Oblast
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Sverdlovskaya Oblast
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Tatarstan, Respublika
Country [56] 0 0
South Africa
State/province [56] 0 0
Free State
Country [57] 0 0
South Africa
State/province [57] 0 0
Gauteng
Country [58] 0 0
South Africa
State/province [58] 0 0
Kwazulu-Natal
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Cataluna
Country [61] 0 0
Spain
State/province [61] 0 0
Murcia, Region De
Country [62] 0 0
Spain
State/province [62] 0 0
Madrid
Country [63] 0 0
Ukraine
State/province [63] 0 0
Dnipropetrovska Oblast
Country [64] 0 0
Ukraine
State/province [64] 0 0
Kharkivska Oblast
Country [65] 0 0
Ukraine
State/province [65] 0 0
Khersonska Oblast
Country [66] 0 0
Ukraine
State/province [66] 0 0
Kyivska Oblast
Country [67] 0 0
Ukraine
State/province [67] 0 0
Mykolaivska Oblast
Country [68] 0 0
Ukraine
State/province [68] 0 0
Odeska Oblast
Country [69] 0 0
Ukraine
State/province [69] 0 0
Vinnytska Oblast
Country [70] 0 0
Ukraine
State/province [70] 0 0
Kyiv
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Camden
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Edinburgh, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04233216