Clinical Trials

MainTitle

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017))

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2020 by Merck Sharp & Dohme Corp.

Sponsor
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT04223778

First received: January 8, 2020
Last updated: May 21, 2020
Last Verified: May 2020
History of Changes
Purpose

Purpose

This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with baseline antiretroviral therapy (ART) as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.

Condition Intervention Phase
HIV Infection

Drug : DOR/ISL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • Participants with HIV-1 RNA ≥50 copies/mL [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48
  • Participants with one or more adverse events (AEs) up to Week 48 [ Time Frame: Day 1 to Week 48 ]
    Percentage of participants with one or more adverse events (AEs) up to Week 48
  • Participants who discontinued study intervention up to Week 48 [ Time Frame: Day 1 to Week 48 ]
    Percentage of participants who discontinued study intervention due to an AE up to Week 48
Secondary Outcome Measures:
  • Participants with HIV-1 RNA <40 or <50 copies/mL [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 48
  • Participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL from Week 48 to Week 96
  • Participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL, <40 copies/mL or <50 copies/mL from Day 1 to Week 96
  • Change from baseline in CD4+ T-cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in cluster of differentiation 4+ (CD4+) T-cell count at Week 48
  • Change from baseline in CD4+ T-cell count at Week 96 [ Time Frame: Baseline and Week 96 ]
    Change from baseline in CD4+ T-cell count at Week 96
  • Change from Week 48 in CD4+ T-cell count at Week 96 [ Time Frame: Week 48 and Week 96 ]
    Change from Week 48 in CD4+ T-cell count at Week 96
  • Participants with evidence of viral drug resistance-associated substitutions at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with evidence of viral drug resistance-associated substitutions at Week 48
  • Participants with evidence of viral drug resistance-associated substitutions at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with evidence of viral drug resistance-associated substitutions at Week 96
  • Change from baseline in fasting low-density lipoprotein cholesterol and nonhigh- density lipoprotein cholesterol to Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline in fasting low-density lipoprotein cholesterol and non-high- density lipoprotein cholesterol to Week 24
  • Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in fasting low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol to Week 48
  • Change from baseline in body weight at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in body weight at Week 48
  • Participants with one or more AEs up to Week 96 [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants with one or more AEs from Day 1 up to Week 96
  • Participants who discontinued study intervention up to Week 96 [ Time Frame: Day 1 to Week 96 ]
    Percentage of participants who discontinued study intervention due to an AE from Day 1 up to Week 96
  • Participants with one or more AEs from Week 48 up to Week 96 [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants with one or more AEs from Week 48 up to Week 96
  • Participants who discontinued study intervention from Week 48 up to Week 96 [ Time Frame: Weeks 48 to 96 ]
    Percentage of participants who discontinued study intervention due to an AE from Week 48 up to Week 96

Estimated Enrollment: 578
Study Start Date: February 18, 2020
Estimated Study Completion Date: September 16, 2022
Estimated Primary Completion Date: October 15, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Immediate Switch to DOR/ISL
Participants receiving continuous antiretroviral therapy (ART) will switch to MK-8591A, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 96 weeks
Drug: DOR/ISL

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

Other Name: MK-8591A
Active Comparator: Baseline Regimen with Delayed Switch to DOR/ISL
Participants receiving continuous ART for 48 weeks will switch to MK-8591A, a FDC of 100 mg DOR/0.75 mg ISL for 48 weeks
Drug: DOR/ISL

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

Other Name: MK-8591A
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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;


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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04223778

Contacts

Contact:   Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations

United States, District of Columbia
Georgetown University Hospital ( Site 1018) Recruiting
Washington, District of Columbia, United States, 20007
Contact: Study Coordinator    202-444-0371
United States, Florida
Midway Immunology and Research ( Site 1030) Recruiting
Fort Pierce, Florida, United States, 34982
Contact: Study Coordinator    772-595-9830
Orlando Immunology Center ( Site 1007) Recruiting
Orlando, Florida, United States, 32803
Contact: Study Coordinator    407-647-3960
Bliss Healthcare Services ( Site 1025) Recruiting
Orlando, Florida, United States, 32806
Contact: Study Coordinator    407-203-5984
Triple O Research Institute, P.A. ( Site 1026) Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Study Coordinator    561-855-7871
United States, Georgia
Chatham County Health Department ( Site 1043) Recruiting
Savannah, Georgia, United States, 31401
Contact: Study Coordinator    912-651-1978
United States, Illinois
Northstar Healthcare ( Site 1002) Recruiting
Chicago, Illinois, United States, 60657
Contact: Study Coordinator    773-296-2400
United States, Missouri
Kansas City CARE Health Center ( Site 1008) Recruiting
Kansas City, Missouri, United States, 64111
Contact: Study Coordinator    816-777-2757
United States, New Jersey
ID Care ( Site 1023) Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Study Coordinator    9082810221164
United States, North Carolina
University of North Carolina at Chapel Hill ( Site 1042) Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Study Coordinator    919-843-9975
United States, Pennsylvania
University of Pennsylvania ( Site 1038) Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Study Coordinator    215-349-8092
United States, Texas
Saint Hope Foundation, Inc. ( Site 1037) Recruiting
Bellaire, Texas, United States, 77401
Contact: Study Coordinator    713-839-7111
North Texas ID Consultants, PA ( Site 1003) Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator    214-276-5618
Texas Centers for Infectious Disease Associates P.A. ( Site 1022) Recruiting
Fort Worth, Texas, United States, 76104
Contact: Study Coordinator    817-348-0042
The Crofoot Research Center, Inc. ( Site 1005) Recruiting
Houston, Texas, United States, 77098
Contact: Study Coordinator    713-526-0005
Australia
Holdsworth House Medical Practice ( Site 2300) Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Study Coordinator    +61293317228
Canada
Vancouver ID Research and Care Centre Society ( Site 1100) Recruiting
Vancouver, British Columbia, Canada, V6Z 2C7
Contact: Study Coordinator    604-642-6429
Hamilton Health Sciences ( Site 1103) Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Study Coordinator    905521210074190
Clinique de Medecine Urbaine du Quartier Latin ( Site 1104) Recruiting
Montreal, Quebec, Canada, H2L 4E9
Contact: Study Coordinator    5142855500
Clinique Medicale L Actuel ( Site 1114) Recruiting
Montreal, Quebec, Canada, H2L 4P9
Contact: Study Coordinator    5145243642271
Chile
Hospital Dr. Hernan Henriquez Aravena ( Site 1305) Recruiting
Temuco, Araucania, Chile, 4781151
Contact: Study Coordinator    +56996420376
Clinica Arauco Salud ( Site 1300) Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 7560994
Contact: Study Coordinator    +56992280653
Colombia
Fundacion Valle del Lili ( Site 1201) Recruiting
Cali, Valle Del Cauca, Colombia, 760032
Contact: Study Coordinator    +573155614943
France
CHU Hotel Dieu Nantes ( Site 2020) Recruiting
Nantes, Loire-Atlantique, France, 44093
Contact: Study Coordinator    +33240083372
A.P.H. Paris, Hopital Saint Louis ( Site 2014) Recruiting
Paris, France, 75010
Contact: Study Coordinator    +33142499066
Italy
ASST Fatebenefratelli-Ospedale Sacco ( Site 2200) Recruiting
Milano, Italy, 20157
Contact: Study Coordinator    +390239043490
Japan
National Hospital Organization Nagoya Medical Center ( Site 2403) Recruiting
Nagoya, Aichi, Japan, 460-0001
Contact: Study Coordinator    +81529511111
National Hospital Organization Osaka National Hospital ( Site 2402) Recruiting
Osaka, Japan, 540-0006
Contact: Study Coordinator    +81669421331
Tokyo Medical University Hospital ( Site 2404) Recruiting
Tokyo, Japan, 160-0023
Contact: Study Coordinator    +81333426111
Center Hospital of the National Center for Global Health and Medicine ( Site 2401) Recruiting
Tokyo, Japan, 162-8655
Contact: Study Coordinator    +81332027181
Russian Federation
Kemerovo Regional Center for the Prevention and Control of AIDS ( Site 1713) Recruiting
Kemerovo, Kemerovskaya Oblast', Russian Federation, 650056
Contact: Study Coordinator    +79069261368
Federal Scientific Methodological AIDS Prevention and Control Center ( Site 1703) Recruiting
Moscow, Moskva, Russian Federation, 105275
Contact: Study Coordinator    +74953653009
Infectious Clinical Hospital #2 ( Site 1719) Recruiting
Moscow, Moskva, Russian Federation, 105275
Contact: Study Coordinator    +79037143865
Saint Petersburg Center for Prophylactic of AIDS and Inf. Diseases ( Site 1701) Recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 190020
Contact: Study Coordinator    +78124959976
FGU Republican Clinical Infectious Hospital of Roszdrav ( Site 1700) Recruiting
Saint Petersburg, Sankt-Peterburg, Russian Federation, 196645
Contact: Study Coordinator    +78124644340
Regional Center for Prevent. and Control of AIDS and Inf. Diseases ( Site 1715) Recruiting
Yekaterinburg, Sverdlovskaya Oblast', Russian Federation, 620102
Contact: Study Coordinator    +79122404119
Republican Clinical Hospital of Infectious Diseases n. a. A.F.Agafonov ( Site 1707) Recruiting
Kazan, Tatarstan, Respublika, Russian Federation, 420140
Contact: Study Coordinator    +78432678117
Switzerland
Universitaetsspital Basel ( Site 3302) Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Study Coordinator    +41612652525
Inselspital Universitaetsspital Bern ( Site 3303) Recruiting
Bern, Berne, Switzerland, 3010
Contact: Study Coordinator    +41316321574
Hopitaux Universitaires de Geneve HUG. ( Site 3304) Recruiting
Geneva, Geneve, Switzerland, 1211
Contact: Study Coordinator    +41223729812
Kantonsspital St. Gallen ( Site 3301) Recruiting
St. Gallen, Sankt Gallen, Switzerland, 9007
Contact: Study Coordinator    +41714942492
Ospedale Regionale di Lugano Civico ( Site 3305) Recruiting
Lugano, Ticino, Switzerland, 6903
Contact: Study Coordinator    +41918056011
Universitaetsspital Zuerich ( Site 3300) Recruiting
Zuerich, Zurich, Switzerland, 8091
Contact: Study Coordinator    +41442553322
United Kingdom
Brighton and Sussex University Hospital NHS Trust ( Site 1908) Recruiting
Brighton, Brighton And Hove, United Kingdom, BN2 1ES
Contact: Study Coordinator    +441273523079
Southmead Hospital ( Site 1910) Recruiting
Bristol, Bristol, City Of, United Kingdom, BS10 5NB
Contact: Study Coordinator    +441174148130
Royal Free Hospital ( Site 1904) Recruiting
London, London, City Of, United Kingdom, NW3 2QG
Contact: Study Coordinator    +442074726232
North Manchester General Hospital ( Site 1902) Recruiting
Manchester, United Kingdom, M8 5RB
Contact: Study Coordinator    +441619223429

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT04223778   History of Changes  
Other Study ID Numbers: 8591A-017  
  2019-000586-20  
  MK-8591A-017  
  205165  
Study First Received: January 8, 2020  
Last Updated: May 21, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
HIV Infections
4'-ethynyl-2-fluoro-2'-deoxyadenosine

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.