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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 12, 2021
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV-I Human Immunodeficiency Virus Type 1 Prophylaxis Drug: ISL Drug: Placebo to FTC/TDF Drug: FTC/TDF Drug: Placebo to ISL Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4500 participants
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
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 Women at High Risk for HIV-1 Infection
Actual Study Start Date : February 24, 2021
Estimated Primary Completion Date : July 5, 2024
Estimated Study Completion Date : July 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: ISL QM
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) once daily
 Drug: ISL
Oral 60mg tablet administered once monthly
Other Name: MK-8591

Drug: Placebo to FTC/TDF
0mg tablet administered once daily
Active Comparator: FTC/TDF QD
FTC/TDF (emtricitabine/tenofovir disoproxil fumarate) once daily AND placebo to ISL (islatravir) once monthly
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Assigned female sex at birth and is cisgender
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT04644029


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

Locations
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United States, District of Columbia
MedStar Health Research Institute (MedStar Physician Based R-MedStar Washington Hospital Center ( Si Recruiting
Washington, District of Columbia, United States, 20010
Contact: Study Coordinator    202-877-0486      
United States, Florida
Orlando Immunology Center ( Site 0068) Recruiting
Orlando, Florida, United States, 32803
Contact: Study Coordinator    40764739602115      
United States, Mississippi
The University of Mississippi Medical Center ( Site 0065) Recruiting
Jackson, Mississippi, United States, 39216
Contact: Study Coordinator    601-815-5009      
United States, Missouri
KC CARE Health Center-Clinical Trials ( Site 0059) Recruiting
Kansas City, Missouri, United States, 64111
Contact: Study Coordinator    816-777-2759      
United States, Texas
Prism Health North Texas, Oak Cliff Health Center ( Site 0070) Recruiting
Dallas, Texas, United States, 75208
Contact: Study Coordinator    972-807-7370      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04644029    
Other Study ID Numbers: 8591-022
MK-8591-022 ( Other Identifier: Merck )
First Posted: November 25, 2020    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 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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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
 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