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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04223778




Registration number
NCT04223778
Ethics application status
Date submitted
8/01/2020
Date registered
10/01/2020

Titles & IDs
Public title
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
Scientific title
A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
Secondary ID [1] 0 0
MK-8591A-017
Secondary ID [2] 0 0
8591A-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

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

Experimental: Doravirine/Islatravir (DOR/ISL) - Participants who were previously treated with continuous background antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.

Active comparator: Baseline Background Antiretroviral Therapy (ART) - Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.


Treatment: Drugs: DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily

Treatment: Drugs: ART
Baseline background ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) =50 Copies/mL at Week 48
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
Timepoint [2] 0 0
Up to ~48 Weeks
Primary outcome [3] 0 0
Percentage of Participants Who Discontinued Study Intervention up to Week 48
Timepoint [3] 0 0
Up to ~48 Weeks
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA =50 Copies/mL, <40 Copies/mL or <50 Copies/mL From Week 48 to Week 96
Timepoint [2] 0 0
Weeks 48-96 (up to ~48 weeks)
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA =50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
Percentage Change From Baseline in CD4+ T-cell Count at Week 48
Timepoint [4] 0 0
Baseline and Week 48
Secondary outcome [5] 0 0
Percentage Change From Baseline in CD4+ T-cell Count at Week 96
Timepoint [5] 0 0
Baseline and Week 96
Secondary outcome [6] 0 0
Percentage Change From Week 48 in CD4+ T-cell Count at Week 96
Timepoint [6] 0 0
Week 48 and Week 96
Secondary outcome [7] 0 0
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48
Timepoint [7] 0 0
Week 48
Secondary outcome [8] 0 0
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
Timepoint [8] 0 0
Week 96
Secondary outcome [9] 0 0
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)
Timepoint [10] 0 0
Baseline and Week 24
Secondary outcome [11] 0 0
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens
Timepoint [11] 0 0
Baseline and Week 24
Secondary outcome [12] 0 0
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)
Timepoint [12] 0 0
Baseline and Week 48
Secondary outcome [13] 0 0
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)
Timepoint [13] 0 0
Baseline and Week 48
Secondary outcome [14] 0 0
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens
Timepoint [14] 0 0
Baseline and Week 48
Secondary outcome [15] 0 0
Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)
Timepoint [15] 0 0
Baseline and Week 48
Secondary outcome [16] 0 0
Percentage of Participants With One or More AEs up to Week 96
Timepoint [16] 0 0
Up to ~96 Weeks
Secondary outcome [17] 0 0
Percentage of Participants Who Discontinued Study Intervention up to Week 96
Timepoint [17] 0 0
Up to ~96 Weeks
Secondary outcome [18] 0 0
Percentage of Participants With One or More AEs From Week 48 to Week 96
Timepoint [18] 0 0
Weeks 48-96
Secondary outcome [19] 0 0
Percentage of Participants Who Discontinued Study Intervention From Week 48 to Week 96
Timepoint [19] 0 0
Weeks 48-96

Eligibility
Key inclusion criteria
* Is HIV-1 positive
* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50 copies/mL) for =3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
* Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; 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; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 Hepatitis B Virus (HBV) co-infection
* 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
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies
* Is currently taking long-acting cabotegravir-rilpivirine
* 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 treatment period
* Has a documented or known virologic resistance to DOR
* Female expects 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
Open (masking not used)
Who is / are masked / blinded?



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
18/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/08/2024
Sample size
Target
Accrual to date
Final
672
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice ( Site 2300) - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309) - Herston
Recruitment hospital [3] 0 0
Melbourne Sexual Health Centre ( Site 2305) - Carlton
Recruitment hospital [4] 0 0
Fiona Stanley Hospital ( Site 2301) - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3053 - Carlton
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
District of Columbia
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
Chile
State/province [14] 0 0
Araucania
Country [15] 0 0
Chile
State/province [15] 0 0
Region Metropolitana De Santiago
Country [16] 0 0
Colombia
State/province [16] 0 0
Valle Del Cauca
Country [17] 0 0
France
State/province [17] 0 0
Cote-d'Or
Country [18] 0 0
France
State/province [18] 0 0
Gironde
Country [19] 0 0
France
State/province [19] 0 0
Haute-Garonne
Country [20] 0 0
France
State/province [20] 0 0
Loire-Atlantique
Country [21] 0 0
France
State/province [21] 0 0
Rhone-Alpes
Country [22] 0 0
France
State/province [22] 0 0
Seine-Maritime
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Italy
State/province [25] 0 0
Napoli
Country [26] 0 0
Italy
State/province [26] 0 0
Roma
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
New Zealand
State/province [30] 0 0
Canterbury
Country [31] 0 0
Poland
State/province [31] 0 0
Dolnoslaskie
Country [32] 0 0
Poland
State/province [32] 0 0
Lodzkie
Country [33] 0 0
Poland
State/province [33] 0 0
Mazowieckie
Country [34] 0 0
Poland
State/province [34] 0 0
Wroclaw
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Kemerovskaya Oblast'
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Krasnoyarskiy Kray
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Leningradskaya Oblast'
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moskva
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Sankt-Peterburg
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Sverdlovskaya Oblast'
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Tatarstan, Respublika
Country [42] 0 0
South Africa
State/province [42] 0 0
Free State
Country [43] 0 0
South Africa
State/province [43] 0 0
Western Cape
Country [44] 0 0
Spain
State/province [44] 0 0
Alicante
Country [45] 0 0
Spain
State/province [45] 0 0
Barcelona [Barcelona]
Country [46] 0 0
Spain
State/province [46] 0 0
Barcelona
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Switzerland
State/province [48] 0 0
Basel-Stadt
Country [49] 0 0
Switzerland
State/province [49] 0 0
Berne
Country [50] 0 0
Switzerland
State/province [50] 0 0
Geneve
Country [51] 0 0
Switzerland
State/province [51] 0 0
Sankt Gallen
Country [52] 0 0
Switzerland
State/province [52] 0 0
Ticino
Country [53] 0 0
Switzerland
State/province [53] 0 0
Zurich
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Brighton And Hove
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Bristol, City Of
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Camden
Country [57] 0 0
United Kingdom
State/province [57] 0 0
London, City Of
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Manchester

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

TypeCitations or Other Details
Journal Molina JM, Rizzardini G, Orrell C, Afani A, Calmy ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04223778