Islatravir

Generic Name: Islatravir

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₁₂FN_₅O_₃

CAS Number: 865363-93-5

Unique Ingredient Identifier: QPQ082R25D

Background: Islatravir is under investigation in clinical trial NCT04233216 (Doravirine/islatravir (DOR/ISL) in Heavily Treatment-experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)).

Associated Conditions: -

Associated Therapies: -

Clinical Trials

A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055)

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: MK-8591A
Drug: Islatravir
Drug: Doravine

First Posted Date: 2024-12-06

Last Posted Date: 2024-12-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 24

Registration Number: NCT06719570

Locations: 🇺🇸
Celerion (Site 0001), Lincoln, Nebraska, United States

A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: MK-8507
Drug: Islatravir

First Posted Date: 2024-09-30

Last Posted Date: 2024-09-30

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 36

Registration Number: NCT06619678

Locations: 🇺🇸
Celerion (Site 0001), Lincoln, Nebraska, United States

A Study of Islatravir (MK-8591) in Trans and Gender Diverse Participants (MK-8591-035)

Phase 2

Withdrawn

Conditions: Human Immunodeficiency Virus (HIV) Infections

Interventions: Drug: Islatravir

First Posted Date: 2021-11-22

Last Posted Date: 2022-10-17

Lead Sponsor: Merck Sharp & Dohme LLC

Registration Number: NCT05130086

Radiopaque Matrix MK-8591 Implant in Participants at Low-Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591-043)

Phase 2

Withdrawn

Conditions: HIV
Human Immunodeficiency Virus

Interventions: Drug: Placebo
Drug: Islatravir

First Posted Date: 2021-11-10

Last Posted Date: 2023-11-24

Lead Sponsor: Merck Sharp & Dohme LLC

Registration Number: NCT05115838

Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)

Phase 3

Terminated

Conditions: HIV-I
Prophylaxis
Human Immunodeficiency Virus Type 1

Interventions: Drug: FTC/TDF
Drug: Islatravir
Drug: Placebo to FTC/TDF
Drug: Placebo to ISL

First Posted Date: 2020-11-25

Last Posted Date: 2024-08-09

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 730

Registration Number: NCT04644029

Locations: 🇺🇬
MU-JHU Care Limited-Clinic ( Site 0041), Kampala, Uganda
🇿🇦
Madibeng Centre for Research ( Site 0019), Brits, North-West, South Africa
🇿🇦
Perinatal HIV Research Unit (PHRU)-HIV Prevention CRS ( Site 0023), Johannesburg, Gauteng, South Africa

and more 21 locations

Islatravir and Methadone Pharmacokinetics (MK-8591-029)

Phase 1

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Islatravir

First Posted Date: 2020-09-29

Last Posted Date: 2023-12-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 14

Registration Number: NCT04568603

Locations: 🇺🇸
Research Centers of America, LLC ( Site 0002), Hollywood, Florida, United States
🇺🇸
PRA Health Sciences ( Site 0001), Salt Lake City, Utah, United States

Dose Ranging, Switch Study of Islatravir (ISL) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]

Phase 2

Active, not recruiting

Conditions: HIV-1 Infection

Interventions: Drug: Islatravir
Drug: BIC/FTC/TAF
Drug: Ulonivirine
Drug: Placebo to ISL
Drug: Placebo to Ulonivirine
Drug: Placebo to BIC/FTC/TAF

First Posted Date: 2020-09-25

Last Posted Date: 2024-11-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 161

Registration Number: NCT04564547

Locations: 🇺🇸
Men's Health Foundation ( Site 2710), Los Angeles, California, United States
🇺🇸
Kansas City CARE Clinic ( Site 2703), Kansas City, Missouri, United States
🇺🇸
Chatham County Health Department ( Site 2707), Savannah, Georgia, United States

and more 20 locations

Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)

Phase 1

Completed

Conditions: Human Immunodeficiency Virus (HIV) Infection

Interventions: Drug: Islatravir

First Posted Date: 2020-08-17

Last Posted Date: 2023-07-03

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 12

Registration Number: NCT04515641

Locations: 🇺🇸
Clinical Pharmacology of Miami ( Site 0001), Miami, Florida, United States

Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026)

Phase 1

Completed

Conditions: Human Immunodeficiency Virus (HIV) Infection

Interventions: Drug: Islatravir

First Posted Date: 2020-03-10

Last Posted Date: 2021-10-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 12

Registration Number: NCT04303156

Locations: 🇺🇸
Clinical Pharmacology of Miami ( Site 0001), Miami, Florida, United States
🇩🇪
Charite Research Organisation GmbH ( Site 0003), Berlin, Germany

Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)

Phase 2

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Islatravir
Drug: Placebo

First Posted Date: 2019-07-01

Last Posted Date: 2023-04-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 242

Registration Number: NCT04003103

Locations: 🇺🇸
Research Centers of America, LLC ( Site 0007), Hollywood, Florida, United States
🇺🇸
Magee Womens Research Institute ( Site 0001), Pittsburgh, Pennsylvania, United States
🇺🇸
Celerion, Inc. ( Site 0006), Lincoln, Nebraska, United States

and more 6 locations

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