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

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ClinicalTrials.gov Identifier: NCT04644029
Recruitment Status : Recruiting
First Posted : November 25, 2020
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE November 25, 2020
Last Update Posted Date April 23, 2021
Actual Study Start Date  ICMJE February 24, 2021
Estimated Primary Completion Date July 5, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • Incidence Rate Per Year of Confirmed HIV-1 Infections [ Time Frame: Up to approximately 36 months ]
    Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections divided by the total 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 incidence rate per year of confirmed HIV-1 Infections in the FTC/TDF QD arm participants. HIV serology tests and polymerase chain reaction (PCR) tests will be done at pre-specified timepoints to confirm HIV-1 infection.
  • Percentage of Participants Who Experienced One or More Adverse Events [ Time Frame: Up to approximately 37 months ]
    An adverse event (AE) is any untoward medical occurrence in a study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
  • Percentage of Participants Who Discontinued Treatment Due to an Adverse Event [ Time Frame: Up to approximately 36 months ]
    An adverse event (AE) is any untoward medical occurrence in a study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign, symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
Incidence Rate per Year of Confirmed HIV-1 Infections Among Participants [ Time Frame: Up to approximately 36 months ]
Incidence rate per year of confirmed HIV-1 infections is the number of participants with confirmed HIV-1 infections divided by the total person-years of follow-up time to HIV-1 infection status. The secondary 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. The background incidence rate will be estimated using tests based on biomarkers that can differentiate "recent" from "nonrecent" infections in the population screened for this study.
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 ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022)
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 Women at High Risk for HIV-1 Infection
Brief Summary This study will evaluate whether oral Islatravir (ISL) is effective in preventing Human Immunodeficiency Virus Type 1 (HIV-1) infection in women at high-risk for HIV-1 infection. The study will compare oral ISL taken once a month with standard-of-care medication for prevention of HIV-1 infection, emtricitabine/tenovir disproxil fumarate (FTC/TDF), taken once per day. The primary hypothesis is that oral ISL is more effective than FTC/TDF at reducing the incidence rate per year of confirmed HIV-1 infections.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
A double-blinding technique with in-house blinding will be used. ISL and FTC/TDF and FTC/TAF will be packaged identically relative to their matching placebos so that blind is maintained. The participant, the investigator, and Sponsor personnel or delegate(s) who are involved in the study intervention administration or clinical evaluation of the participants are unaware of the intervention assignments.
Primary Purpose: Prevention
Condition  ICMJE
  • HIV-I
  • Human Immunodeficiency Virus Type 1
  • Prophylaxis
Intervention  ICMJE
  • Drug: ISL
    Oral 60mg tablet administered once monthly
    Other Name: MK-8591
  • Drug: Placebo to FTC/TDF
    0mg tablet administered once daily
  • Drug: FTC/TDF
    200/245mg or 200/300mg tablet administered orally once daily
    Other Names:
    • TRUVADA
    • Emtricitabine/Tenofovir disoproxil fumarate
  • Drug: Placebo to ISL
    0mg tablet administered orally once monthly
Study Arms  ICMJE
  • Experimental: ISL QM
    ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) once daily
    Interventions:
    • Drug: ISL
    • Drug: Placebo to FTC/TDF
  • Active Comparator: FTC/TDF QD
    FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) once daily AND placebo to ISL (islatravir) once monthly
    Interventions:
    • Drug: FTC/TDF
    • 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: November 23, 2020)
4500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 5, 2024
Estimated Primary Completion Date July 5, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed HIV-uninfected based on negative HIV-1/HIV-2 test results before randomization.
  • Sexually active with a male sexual partner in the 30 days prior to screening.
  • High risk for HIV-1 infection.
  • Not pregnant or breastfeeding, and one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or is a WOCBP and is using an acceptable contraceptive method during the intervention period and for at least 42 days after the last dose.
  • A WOCBP must have a negative pregnancy test within 24 hours prior to the first dose of study intervention.

Exclusion Criteria:

  • Hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
  • Active hepatitis B virus (HBV) infection.
  • Current or chronic history of liver disease.
  • History of malignancy within 5 years of screening except for adequately-treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
  • Past or current use of cabotegravir.
  • Currently participating in or has participated in an interventional clinical study with an investigational compound or device, within 30 days prior to Day 1.
  • Expecting to conceive or donate eggs at any time during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Assigned female sex at birth and is cisgender
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04644029
Other Study ID Numbers  ICMJE 8591-022
MK-8591-022 ( Other Identifier: Merck )
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 April 2021

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