Oral Islatravir (MK-8591) Once-Monthly as Preexposure Prophylaxis (PrEP) in Men and Transgender Women Who Are at High Risk for HIV-1 Infection (MK-8591-024) (Impower-024)
|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: NCT04652700|
Recruitment Status : Active, not recruiting
First Posted : December 3, 2020
Last Update Posted : August 17, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|HIV Preexposure Prophylaxis||Drug: ISL Drug: FTC/TDF Drug: FTC/TAF Drug: Placebo to ISL Drug: Placebo to FTC/TDF Drug: Placebo to FTC/TAF||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||494 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
In Study Part 1, double-blind with in-house blinding is used.
In Study Part 2, sponsor personnel not directly involved with blinded safety monitoring will be unblinded to participants' randomized study intervention in Part 1 (personnel involved with Part 2 will remain blinded).
In Study Part 3, al participants, investigators, and Sponsor personnel are unblinded as to the participant's original randomized 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 Men and Transgender Women Who Have Sex With Men, and Are at High Risk for HIV-1 Infection|
|Actual Study Start Date :||March 15, 2021|
|Estimated Primary Completion Date :||January 2, 2024|
|Estimated Study Completion Date :||September 27, 2024|
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.
ISL 60 mg tablet, QM, orally for up to 24 months
Other Name: MK-8591
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
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.
Participants receive 200/245 mg of FTC/TDF combination tablet, QD, orally for up to 24 months
Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months
Drug: Placebo to ISL
Placebo ISL 0 mg tablets QM, orally for up to 24 months.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|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|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
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): NCT04652700
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
MK-8591-024 ( Other Identifier: Merck )
jRCT2031200419 ( Registry Identifier: jRCT )
2020-003309-79 ( EudraCT Number )
|First Posted:||December 3, 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)
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Emtricitabine tenofovir alafenamide
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action