Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011)
NCT ID: NCT03272347
Last Updated: 2023-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
123 participants
INTERVENTIONAL
2017-11-27
2022-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Islatravir 0.25 mg
Participants will be treated once daily (QD) with 0.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
Islatravir
Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
Doravirine
Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
Lamivudine
Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
Doravirine/Islatravir
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
Islatravir 0.75 mg
Participants will be treated QD with 0.75 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and will continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
Islatravir
Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
Doravirine
Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
Lamivudine
Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
Doravirine/Islatravir
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
Islatravir 2.25 mg
Participants will be treated QD with 2.25 mg islatravir, 100 mg DOR, 300 mg 3TC, and placebo to DOR/3TC/TDF for a minimum of 24 weeks. Between week 24 through week 52, 3TC and placebo to DOR/3TC/TDF may be discontinued. Around Week 60, participants may be switched to a selected open label dose of islatravir and DOR 100 mg QD and will continue treatment until Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
Islatravir
Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
Doravirine
Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
Lamivudine
Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
Doravirine/Islatravir
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
DOR/3TC/TDF
Participants will be treated QD with placebo to islatravir, placebo to DOR, placebo to 3TC, and a fixed dose combination of DOR/3TC/TDF consisting of 100 mg DOR + 300 mg 3TC + 300 mg TDF for a minimum of 24 weeks. Between week 24 through week 52 placebo treatments may be discontinued and participants will receive only DOR/3TC/TDF QD open label up to Week 144. At Week 144 participants will receive the fixed dose combination of doravirine (100mg)/islatravir (0.75mg) QD open label and will continue treatment until Week 192.
Placebo to Islatravir
Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks
Placebo to Doravirine
Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks
Placebo to Lamivudine
Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.
Doravirine/Islatravir
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
Interventions
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Islatravir
Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
Placebo to Islatravir
Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks
Doravirine
Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
Placebo to Doravirine
Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks
Lamivudine
Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
Placebo to Lamivudine
Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks
Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Fixed dose combination of 100 mg doravirine + 300 mg lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.
Placebo to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate
Placebo to doravirine/lamivudine/tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 52 weeks
Doravirine/Islatravir
Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is naïve to anti-retroviral therapy (ART).
* Is clinically stable, with no signs or symptoms of acute infection, at the time of entry into the study
* Female is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP); but if WOCBP agrees to follow the contraceptive guidance
* All participants, male and female, agree to use barrier methods of contraception when engaged in any sexual activity during treatment and for 6 weeks following treatment.
Exclusion Criteria
* Has significant hypersensitivity or other contraindication to any of the components of the study drugs
* Has a history of malignancy ≤5 years prior
* Female expects to donate eggs at any time during the study
* Is breastfeeding or expecting to conceive
* A WOCBP who has a positive urine pregnancy test on Day 1 before the first dose of study treatment
* Has been treated for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1
* Has used systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study
* Requires any of the following prohibited medications: Carbamazepine, Phenobarbital, Phenytoin, Rifabutin, Rifampin, Herbal remedies, St. John's Wort, Modafinil, Bosentan, Nafcillin, Pentostatin
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing informed consent to participate in this current trial
* Has a documented or known virologic resistance to any approved HIV-1 reverse transcriptase inhibitor, protease inhibitor, integrase inhibitor
* Has active hepatitis C virus (HCV) coinfection defined as detectable HCV RNA or HBV co-infection defined as hepatitis B surface antigen \[HBsAg\]-positive
* Has a current (active) diagnosis of acute hepatitis due to any cause
* Has previously been randomized in a study and received islatravir (MK-8591), DOR, Doravirine, Tenofovir, Lamivudine, or 3TC.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Pueblo Family Physicians ( Site 0119)
Phoenix, Arizona, United States
University California / Davis ( Site 0101)
Sacramento, California, United States
Whitman Walker Clinic ( Site 0108)
Washington D.C., District of Columbia, United States
Orlando Immunology Center (OIC) ( Site 0105)
Orlando, Florida, United States
Northstar Medical Center ( Site 0102)
Chicago, Illinois, United States
Kansas City CARE Clinic ( Site 0106)
Kansas City, Missouri, United States
Saint Hope Foundation, Inc. ( Site 0116)
Bellaire, Texas, United States
North Texas Infectious Diseases Consultants, PA ( Site 0103)
Dallas, Texas, United States
Tarrant County Infectious Disease Associates ( Site 0112)
Fort Worth, Texas, United States
The Crofoot Research Center, Inc. ( Site 0118)
Houston, Texas, United States
Clinica Arauco Salud ( Site 0200)
Santiago, RM, Chile
Biomedica Research Group ( Site 0202)
Santiago, , Chile
Hospital Dr. Hernan Henriquez Aravena ( Site 0203)
Temuco, , Chile
Hopital Avicenne ( Site 2302)
Bobigny, , France
Hopital Saint-Andre ( Site 2307)
Bordeaux, , France
CHU Hotel Dieu ( Site 2308)
Nantes, , France
CHU de Nice Hopital Archet 1 ( Site 2303)
Nice, , France
Hopital Bichat - Claude Bernard ( Site 2309)
Paris, , France
Hopital Pitie Salpetriere ( Site 2305)
Paris, , France
Hopital Saint Louis ( Site 2306)
Paris, , France
Centre Hospitalier de Tourcoing ( Site 2301)
Tourcoing, , France
Brighton and Sussex University Hospitals NHS Trust ( Site 2105)
Brighton, East Sussex, United Kingdom
Chelsea and Westminster Hospital ( Site 2101)
London, , United Kingdom
Royal London Hospital ( Site 2103)
London, , United Kingdom
The Royal Free London NHS Foundation Trust ( Site 2102)
London, , United Kingdom
North Manchester General Hospital ( Site 2104)
Manchester, , United Kingdom
Countries
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References
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Molina JM, Yazdanpanah Y, Afani Saud A, Bettacchi C, Chahin Anania C, Klopfer SO, Grandhi A, Eves K, Hepler D, Robertson MN, Hwang C, Hanna GJ, Correll T. Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):68-72. doi: 10.1097/QAI.0000000000002879. Epub 2021 Dec 8.
Molina JM, Yazdanpanah Y, Afani Saud A, Bettacchi C, Chahin Anania C, DeJesus E, Olsen Klopfer S, Grandhi A, Eves K, Robertson MN, Correll T, Hwang C, Hanna GJ, Sklar P. Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial. Lancet HIV. 2021 Jun;8(6):e324-e333. doi: 10.1016/S2352-3018(21)00021-7. Epub 2021 May 14.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-000437-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
8591-011
Identifier Type: -
Identifier Source: org_study_id
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