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 : Active, not recruiting
First Posted : November 25, 2020
Last Update Posted : August 17, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HIV-I Human Immunodeficiency Virus Type 1 Prophylaxis||Drug: Islatravir Drug: Placebo to FTC/TDF Drug: FTC/TDF Drug: Placebo to ISL||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||730 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
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.
|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|
Experimental: ISL QM
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily during Part 1.
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.
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.
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.
Drug: Placebo to ISL
0 mg tablet administered orally once monthly in Part 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.
- 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.
- 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.
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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|
- 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.
- 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.
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
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
MK-8591-022 ( Other Identifier: Merck )
2021-001289-39 ( EudraCT Number )
|First Posted:||November 25, 2020 Key Record Dates|
|Last Update Posted:||August 17, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Preexposure prophylaxis (PrEP)
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Immune System Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Slow Virus Diseases
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action