Clinical Trials

MainTitle

Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)

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
NCT04223791

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 regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF 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
Drug : BIC/FTC/TAF
Drug : Placebo to BIC/FTC/TAF
Drug : Placebo to FDC DOR/ISL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV- 1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

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

Primary Outcome Measures

  • Participants with (Human Immunodeficiency Virus 1 ribonucleic acid ) HIV-1 RNA ≥50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with (Human Immunodeficiency Virus 1 ribonucleic acid) HIV-1 RNA ≥50 copies/mL at Week 48
  • Participants with one or more adverse events (AEs) up to Week 48 [ Time Frame: Up to 48 weeks ]
    Percentage of participants with one or more adverse events (AEs) up to Week 48
  • Participants who discontinued study intervention due to an AE up to Week 48 [ Time Frame: Up to 48 weeks ]
    Percentage of participants who discontinued study intervention due to an AE up to Week 48
Secondary Outcome Measures:
  • Participants with HIV-1 RNA ≥50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96
  • Participants with HIV-1 RNA <40 or <50 copies/mL at Week 48 [ Time Frame: Week 48 ]
    Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 48
  • Participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 [ Time Frame: Week 96 ]
    Percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96
  • CD4+ T-cell count at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in CD4+ T-cell count at Week 48
  • CD4+ T-cell count at Week 96 [ Time Frame: Baseline and Week 96 ]
    Change from baseline 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 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 participants with evidence of viral drug resistance-associated substitutions at Week 96
  • Change from baseline in body weight at Week 48 [ Time Frame: Baseline and Week 48 ]
    Change from baseline in body weight at Week 48
  • Change from baseline in body weight at Week 96 [ Time Frame: Baseline and Week 96 ]
    Change from baseline in body weight at Week 96
  • Participants with one or more AEs up to Week 96 [ Time Frame: Up to Week 96 ]
    Percentage of participants with one or more AEs up to Week 96
  • Participants who discontinued study intervention due to an AE up to Week 96 [ Time Frame: Up to Week 96 ]
    Percentage of participants who discontinued study intervention due to an AE 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: DOR/ISL
A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 96 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks
Drug: DOR/ISL

100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily

Other Name: MK-8591A
Drug: Placebo to BIC/FTC/TAF

Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily

Active Comparator: BIC/FTC/TAF
50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 96 weeks, and placebo to FDC DOR/ISL for 96 weeks
Drug: BIC/FTC/TAF

50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily

Drug: Placebo to FDC DOR/ISL

Placebo to FDC DOR/ISL in a tablet taken orally, once daily

Other Name: Placebo to 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 with plasma (Human Immunodeficiency Virus 1) HIV-1 RNA <50 copies/mL at screening.
  • Has been receiving BIC/FTC/TAF therapy 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 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 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: NCT04223791

Contacts

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

Locations

United States, Arizona
Pueblo Family Physicians ( Site 2717) Active, not recruiting
Phoenix, Arizona, United States, 85015
United States, California
Pacific Oaks Medical Group ( Site 2765) Recruiting
Beverly Hills, California, United States, 90211
Contact: Study Coordinator    310-967-3620
Men's Health Foundation ( Site 2749) Recruiting
Los Angeles, California, United States, 80069
Contact: Study Coordinator    310-550-1010
Kaiser Permanente Los Angeles Medical Center ( Site 2775) Recruiting
Los Angeles, California, United States, 90027
Contact: Study Coordinator    323-783-8977
Eisenhower Medical Center ( Site 2744) Recruiting
Palm Springs, California, United States, 92264
Contact: Study Coordinator    760-834-7949
University of California, Davis, Division of ID Research ( Site 2702) Recruiting
Sacramento, California, United States, 95811
Contact: Study Coordinator    916-914-6261
Zuckerberg San Francisco General Hospital UCSF ( Site 2743) Recruiting
San Francisco, California, United States, 94110
Contact: Study Coordinator    4154764082ext353
United States, District of Columbia
Whitman-Walker Clinic ( Site 2728) Recruiting
Washington, District of Columbia, United States, 20009
Contact: Study Coordinator    202-745-6139
United States, Florida
TheraFirst Medical Center ( Site 2742) Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact: Study Coordinator    954javascript:void(0)5644222
Midway Immunology and Research ( Site 2759) Recruiting
Fort Pierce, Florida, United States, 34982
Contact: Study Coordinator    772-595-9830
AHF South Beach ( Site 2780) Recruiting
Miami Beach, Florida, United States, 33140
Contact: Study Coordinator    30553814002520
The Kinder Medical Group ( Site 2739) Recruiting
Miami, Florida, United States, 33133
Contact: Study Coordinator    786-497-4000
Orlando Immunology Center ( Site 2734) Recruiting
Orlando, Florida, United States, 32803
Contact: Study Coordinator    407-647-3960
Triple O Research Institute, P.A. ( Site 2755) Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Study Coordinator    561-855-7871
United States, Georgia
Augusta University ( Site 2752) Recruiting
Augusta, Georgia, United States, 30912
Contact: Study Coordinator    706-723-0106
Infectious Disease Specialists Of Atlanta PC ( Site 2719) Recruiting
Decatur, Georgia, United States, 30033
Contact: Study Coordinator    404-297-9755
Mercer University ( Site 2738) Recruiting
Macon, Georgia, United States, 31201
Contact: Study Coordinator    478-301-5851
Chatham County Health Department ( Site 2731) Recruiting
Savannah, Georgia, United States, 31401
Contact: Study Coordinator    912-651-1978
United States, Minnesota
Hennepin County Medical Center ( Site 2733) Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Study Coordinator    612-873-7516
United States, Missouri
Kansas City CARE Clinic ( Site 2718) Recruiting
Kansas City, Missouri, United States, 64111
Contact: Study Coordinator    816-777-2757
United States, New Jersey
ID Care ( Site 2751) Recruiting
Hillsborough, New Jersey, United States, 08844
Contact: Study Coordinator    908-281-0221 Ext. 164
United States, New York
Montefiore Einstein Center ( Site 2730) Recruiting
Bronx, New York, United States, 10467
Contact: Study Coordinator    718-920-5904
Icahn School of Medicine at Mount Sinai ( Site 2700) Recruiting
New York, New York, United States, 10029
Contact: Study Coordinator    212-824-7821
United States, Texas
North Texas ID Consultants, PA ( Site 2707) Recruiting
Dallas, Texas, United States, 75246
Contact: Study Coordinator    214-276-5618
The Crofoot Research Center, Inc. ( Site 2715) Recruiting
Houston, Texas, United States, 77098
Contact: Study Coordinator    713-526-0005
DCOL Center for Clinical Research ( Site 2769) Recruiting
Longview, Texas, United States, 75605
Contact: Study Coordinator    903-238-8854
United States, Washington
Dr. Peter Shalit, MD ( Site 2770) Recruiting
Seattle, Washington, United States, 98104
Contact: Study Coordinator    206-624-1441
Multicare Health System ( Site 2713) Recruiting
Spokane, Washington, United States, 99204
Contact: Study Coordinator    253-403-7251
Australia
Holdsworth House Medical Practice ( Site 3800) Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Study Coordinator    +61293317228
Holdsworth House Medical Practice ( Site 3810) Recruiting
Brisbane, Queensland, Australia, 4006
Contact: Study Coordinator    +61293317228
Austria
Medical University Vienna ( Site 3402) Recruiting
Vienna, Wien, Austria, 1090
Contact: Study Coordinator    +4314040042480
Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400) Recruiting
Vienna, Wien, Austria, 1100
Contact: Study Coordinator    +431601912408
Social Medical Center - Otto Wagner Hospital ( Site 3404) Recruiting
Vienna, Wien, Austria, 1145
Contact: Study Coordinator    +4319106042008
Canada
Vancouver ID Research and Care Centre Society ( Site 2800) Recruiting
Vancouver, British Columbia, Canada, V6Z 2C7
Contact: Study Coordinator    604-642-6429
Hamilton Health Sciences ( Site 2803) Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Study Coordinator    905521210073538
Clinique de Medecine Urbaine du Quartier Latin ( Site 2804) Recruiting
Montreal, Quebec, Canada, H2L 4E9
Contact: Study Coordinator    5142855500
Clinique Medicale L Actuel ( Site 2814) Recruiting
Montreal, Quebec, Canada, H2L 4P9
Contact: Study Coordinator    5145243642271
Finland
Helsinki University Hospital ( Site 3200) Recruiting
Helsinki, Uusimaa, Finland, 00029
Contact: Study Coordinator    +358504270802
France
Hopital Edouard Herriot ( Site 3126) Recruiting
Lyon, Auvergne, France, 69003
Contact: Study Coordinator    +33472110230
Hopital Foch ( Site 3129) Recruiting
Suresnes, Hauts-de-Seine, France, 92150
Contact: Study Coordinator    +33146252093
CHU de Montpellier - Hopital Saint-Eloi ( Site 3121) Recruiting
Montpellier, Herault, France, 34295
Contact: Study Coordinator    +33467337220
CHU Hotel Dieu Nantes ( Site 3120) Recruiting
Nantes, Loire-Atlantique, France, 44093
Contact: Study Coordinator    +33240083372
CHU de Nancy Hopital Brabois Adultes ( Site 3128) Recruiting
Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54511
Contact: Study Coordinator    +33383154097
Centre Hospitalier de Tourcoing ( Site 3100) Recruiting
Tourcoing, Nord, France, 59208
Contact: Study Coordinator    +33320694617
Hopital Saint-Antoine ( Site 3113) Recruiting
Paris, France, 75012
Contact: Study Coordinator    +33149283137
Hopital Pitie Salpetriere ( Site 3111) Recruiting
Paris, France, 75013
Contact: Study Coordinator    +33142160144
Hopital Tenon ( Site 3118) Recruiting
Paris, France, 75020
Contact: Study Coordinator    +33156017436
Germany
MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002) Recruiting
Muenchen, Bayern, Germany, 80335
Contact: Study Coordinator    +49895587030
Klinikum der LMU München ( Site 3004) Recruiting
Muenchen, Bayern, Germany, 80336
Contact: Study Coordinator    +49 89 4400 53457
Klinikum rechts der Isar der Technischen Universitat ( Site 3005) Recruiting
Muenchen, Bayern, Germany, 81675
Contact: Study Coordinator    +498941402455
Infektiologikum ( Site 3001) Recruiting
Frankfurt am Main, Hessen, Germany, 60596
Contact: Study Coordinator    +49 69 69597230
Medizinische Hochschule Hannover ( Site 3012) Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Study Coordinator    +495115325155
Universitaetsklinikum Bonn ( Site 3000) Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53127
Contact: Study Coordinator    +49222815421
Universitaetsklinikum Essen ( Site 3007) Recruiting
Essen, Nordrhein-Westfalen, Germany, 45122
Contact: Study Coordinator    +492017233878
Zentrum fur Infektiologie Berlin Prenzlauer Berg (zibp) ( Site 3003) Recruiting
Berlin, Germany, 10439
Contact: Study Coordinator    +4930233212870
EPIMED GmbH ( Site 3008) Recruiting
Berlin, Germany, 12167
Contact: Study Coordinator    +4930130202834
ICH Study Center GmbH & Co.KG ( Site 3009) Recruiting
Hamburg, Germany, 20146
Contact: Study Coordinator    +494028407370
Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010) Recruiting
Hamburg, Germany, 20246
Contact: Study Coordinator    +4940741052682
Italy
Azienda Ospedaliera San Paolo ( Site 3503) Recruiting
Milano, Italy, 20142
Contact: Study Coordinator    +390281843045
ASST Fatebenefratelli-Ospedale Sacco ( Site 3500) Recruiting
Milano, Italy, 20157
Contact: Study Coordinator    +390239043490
Japan
National Hospital Organization Nagoya Medical Center ( Site 7203) Recruiting
Nagoya, Aichi, Japan, 460-0001
Contact: Study Coordinator    +81529511111
National Hospital Organization Osaka National Hospital ( Site 7202) Recruiting
Osaka, Japan, 540-0006
Contact: Study Coordinator    +81669421331
Center Hospital of the National Center for Global Health and Medicine ( Site 7201) Recruiting
Tokyo, Japan, 162-8655
Contact: Study Coordinator    +81332027181
Puerto Rico
CAIMED Center - Ponce School of Medicine ( Site 2903) Recruiting
Ponce, Puerto Rico, 00716
Contact: Study Coordinator    7878402505
Puerto Rico CONCRA ( Site 2904) Recruiting
Rio Piedras, Puerto Rico, 00925
Contact: Study Coordinator    +7877539443
Clinical Research Puerto Rico Inc ( Site 2900) Recruiting
San Juan, Puerto Rico, 00909
Contact: Study Coordinator    +7877235945
Hope Clinical Research, Inc. ( Site 2902) Recruiting
San Juan, Puerto Rico, 00909
Contact: Study Coordinator    7872687078
Spain
Hospital Universitari de Bellvitge ( Site 3612) Recruiting
LHospitalet de Llobregat, Barcelona [Barcelona], Spain, 08907
Contact: Study Coordinator    +34932607667

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: NCT04223791   History of Changes  
Other Study ID Numbers: 8591A-018  
  2019-000587-23  
  MK-8591A-018  
  205166  
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.