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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04644029
Recruitment Status : Active, not recruiting
First Posted : November 25, 2020
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE November 25, 2020
Last Update Posted Date August 17, 2022
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/tenofovir disoproxil (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 Based on laboratory findings of decreased lymphocyte and CD4+ T-cell counts across the islatravir program, dosing of blinded study intervention was halted on 13-Dec-2021 and screening and randomization of new participants was ended. Blinded assessments conducted prior to this date are designated as Study Part 1. During Study Part 2, participants from Part 1 have the option to receive daily FTC/TDF while continuing in the study. Study Part 3 was added to unblind each participant's Part 1 study intervention assignment, continue participants on FTC/TDF, and monitor safety.
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:

In Study Part 1, 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.

In Study Part 2, sponsor personnel not directly involved with blinded safety monitoring will be unblinded to participants' randomized study intervention in Part 1.

In Study Part 3, participants, investigators, and all Sponsor personnel will be unblinded to the participants' original randomized study intervention group.

Primary Purpose: Prevention
Condition  ICMJE
  • HIV-I
  • Human Immunodeficiency Virus Type 1
  • Prophylaxis
Intervention  ICMJE
  • Drug: Islatravir
    Oral 60 mg tablet administered once monthly during Part 1.
    Other Name: MK-8591
  • Drug: Placebo to FTC/TDF
    0 mg tablet administered once daily during Part 1.
  • Drug: FTC/TDF
    Each tablet contains 200 mg emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg tenofovir disoproxil fumarate or 201.22 mg tenofovir disproxil phosphate), administered orally once daily in Parts 1, 2, and 3.
    Other Names:
    • TRUVADA™
    • Emtricitabine/Tenofovir disoproxil
    • Emtricitabine/Tenofovir disoproxil fumarate
  • Drug: Placebo to ISL
    0 mg tablet administered orally once monthly in Part 1.
Study Arms  ICMJE
  • Experimental: ISL QM
    ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily during Part 1.
    Interventions:
    • Drug: Islatravir
    • Drug: Placebo to FTC/TDF
  • Active Comparator: FTC/TDF QD
    FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily in Parts 1, 2, and 3. Placebo to ISL (islatravir) also administered once monthly during Part 1.
    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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 10, 2022)
730
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
4500
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 (vaginal and/or anal sex) 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.
  • Findings of chronic hepatitis B virus (HBV) infection or past HBV.
  • 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, lenacapavir, or any other long-acting HIV prevention product.
  • 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   Uganda,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04644029
Other Study ID Numbers  ICMJE 8591-022
MK-8591-022 ( Other Identifier: Merck )
2021-001289-39 ( EudraCT Number )
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
Current Responsible Party Merck Sharp & Dohme LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Merck Sharp & Dohme LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Merck Sharp & Dohme LLC
Verification Date August 2022

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