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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.

Tracking Information
First Submitted Date  ICMJE December 2, 2020
First Posted Date  ICMJE December 3, 2020
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date January 2, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-blind with in-house blinding
Primary Purpose: Prevention
Condition  ICMJE HIV Preexposure Prophylaxis
Intervention  ICMJE
  • Drug: ISL
    ISL 60 mg tablet, QM, orally for up to 24 months
    Other Name: MK-8591
  • 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.
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: ISL
    • Drug: Placebo to FTC/TDF
    • Drug: Placebo to FTC/TAF
  • 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.
    Interventions:
    • Drug: FTC/TDF
    • Drug: FTC/TAF
    • Drug: Placebo to ISL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 2, 2020)
1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 27, 2024
Estimated Primary Completion Date January 2, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
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
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE France,   Japan,   Peru,   South Africa,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04652700
Other Study ID Numbers  ICMJE 8591-024
MK-8591-024 ( Other Identifier: Merck )
2020-003309-79 ( EudraCT Number )
jRCT2031200419 ( Registry Identifier: jRCT )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP