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)
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|ClinicalTrials.gov Identifier: NCT04652700|
Recruitment Status : Active, not recruiting
First Posted : December 3, 2020
Last Update Posted : August 17, 2022
|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.
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|