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Trial record 9 of 15 for:    islatravir

Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Have Sex With Men and Are at High Risk for HIV-1 Infection (MK-8591-024) (Impower-024)

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ClinicalTrials.gov Identifier: NCT04652700
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The main purpose of the study is to evaluate the efficacy and safety of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization. The primary hypothesis of the study is that the administration of ISL QM as PreP reduces the incidence rate per year of the confirmed HIV-1 infections compared to the background incidence rates.

Condition or disease Intervention/treatment Phase
HIV Preexposure Prophylaxis Drug: ISL Drug: FTC/TDF Drug: FTC/TAF Drug: Placebo to ISL Drug: Placebo to FTC/TDF Drug: Placebo to FTC/TAF Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind with in-house blinding
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Oral Islatravir Once-Monthly as Preexposure Prophylaxis in Cisgender Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : January 2, 2024
Estimated Study Completion Date : September 27, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Islatravir (ISL) Once Monthly (QM) Group
Participants receive 60 mg tablet of ISL QM, orally plus Placebo to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) tablet once daily (QD) or Placebo to Emtricitabine/Tenofovir Alafenamide (FTC/TAF) tablet QD, orally for up to 24 months of treatment duration.
Drug: ISL
ISL 60 mg tablet, QM, orally for up to 24 months
Other Name: MK-8591

Drug: Placebo to FTC/TDF
Placebo FTC/TDF 0 mg tablets QD, orally for up to 24 months

Drug: Placebo to FTC/TAF
Placebo FTC/TAF 0 mg tablets QD, orally for up to 24 months

Active Comparator: FTC/TDF or FTC/TAF QD Group
Participants receive 200/245 mg or 200/300 mg of FTC/TDF combination tablet, QD, orally or 200/25 mg of FTC/TAF combination tablet, QD, orally at investigator's discretion plus Placebo to ISL tablet QM, orally for up to 24 months of treatment duration.
Drug: FTC/TDF
Participants receive 200/245 mg or 200/300 mg of FTC/TDF combination tablet, QD, orally for up to 24 months
Other Names:
  • Truvada
  • Emtricitabine/Tenofovir Disoproxil Fumarate

Drug: FTC/TAF
Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months
Other Names:
  • Descovy
  • Emtricitabine/Tenofovir Alafenamide

Drug: Placebo to ISL
Placebo ISL 0 mg tablets QM, orally for up to 24 months.




Primary Outcome Measures :
  1. Incidence Rate Per Year of Confirmed Human Immunodeficiency Virus 1 (HIV-1) Infection [ Time Frame: Up to approximately 24 months ]
    Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status. The primary analysis will compare the incidence rate per year of confirmed HIV-1 Infections between the ISL QM arm participants and the background incidence rate calculated from screened participants. HIV serology tests and polymerase chain reaction (PCR) tests will be done at pre-specified timepoints to confirm HIV-1 infection. The background incidence rate will be estimated using tests based on biomarkers that can differentiate recent from non-recent infections in the population screened for this study.

  2. Percentage of Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to approximately 26 months ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE will be reported for each treatment arm.

  3. Percentage of Participants Who Discontinued Study Treatment Due to an AE [ Time Frame: Up to approximately 24 months ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced an AE will be reported for each treatment arm.


Secondary Outcome Measures :
  1. Incidence Rate Per Year of Confirmed HIV-1 infection Among Participants [ Time Frame: Up to approximately 24 months ]
    Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections divided by the amount of person-years of follow-up time to HIV-1 infection status. The secondary incidence analysis to compare the incidence rate per year of confirmed HIV-1 Infections between the ISL QM arm and the FTC/TDF or FTC/TAF QD arm participants. HIV serology tests and PCR tests will be done at pre-specified timepoints to confirm HIV-1 infection.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male participants and transgender women (TGW) who are at high risk for HIV-1 infection
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has confirmed Human Immunodeficiency Virus (HIV) uninfected based on negative HIV-1/HIV-2 test result before randomization
  • Is sexually active with male or transgender women (TGW) partners defined as having anal sexual intercourse with a man or TGW at least once in the past month
  • Is at high risk for sexually acquiring HIV-1 infection based on self-report of at least 1 of the following: a) Condomless receptive anal intercourse in the 6 months prior to screening occurring outside a mutually monogamous HIV seronegative concordant relationship b) More than 5 partners (anal intercourse) in the 6 months prior to screening c) Any unprescribed stimulant drug use in the 6 months prior to screening d) Rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening
  • Participants 16 or 17 years of age must weigh ≥35 kg. Enrollment for 16- to 17-year-old participants will begin only after completion of the Sentinel Cohort IA and review of IA results by the external data monitoring committee (eDMC)
  • Has no plans to relocate or travel away from the site for ≥4 consecutive weeks during study participation

Exclusion Criteria:

  • Has hypersensitivity or other contraindication to any component of the study interventions as determined by the investigator
  • Has chronic HBV infection or past HBV infection which could indicate risk for Hepatitis B reactivation
  • Has known current or chronic history of liver disease or known hepatic or biliary abnormalities, unless the participant has stable liver function tests and no evidence of hepatic synthetic dysfunction
  • Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer or in situ anal cancers
  • Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might, in the opinion of the investigator, confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to enroll
  • Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time
  • Is currently receiving or is anticipated to require any prohibited therapies outlined in the study from 30 days prior to Day 1 through the duration of the study
  • Is currently participating in or has participated in an interventional or prevention clinical study with an investigational compound or device, within 30 days prior to Day 1 through the duration of the study
  • Has exclusionary laboratory values within 45 days prior to Day 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652700


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

Locations
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Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04652700    
Other Study ID Numbers: 8591-024
MK-8591-024 ( Other Identifier: Merck )
2020-003309-79 ( EudraCT Number )
jRCT2031200419 ( Registry Identifier: jRCT )
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Preexposure prophylaxis (PrEP)
Prevention
Additional relevant MeSH terms:
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Infection
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents