Trial record 5 of 21 for:
ISLATRAVIR
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 |
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Recruitment Status :
Active, not recruiting
First Posted : December 3, 2020
Last Update Posted : August 17, 2022
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Sponsor:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC
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Brief Summary:
The main purpose of the study is to evaluate the safety and tolerability of oral Islatravir (ISL) once monthly (QM) as Preexposure Prophylaxis (PrEP) in cisgender men who have sex with men (MSM) and transgender women (TGW) who have sex with men and who are at high risk of HIV-1 infection with 48 or 96 weeks of treatment and a minimum follow-up of 42 days.
| 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 |
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. Blinded assessments conducted prior to then are designated as Study Part 1. During Study Part 2, participants from Part 1 were switched to PrEP therapy with emtricitabine/tenofovir disoproxil (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF) while continuing in the study. In Part 3, participants, investigators, and all Sponsor personnel are unblinded to participant's original randomized intervention group, and participants may continue to receive unblinded FTC/TDF or FTC/TAF. Screening and randomization of new participants have stopped, with no new participants being enrolled in Part 2 or Part 3.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 494 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | 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. |
| 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 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: ISL
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 |
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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.
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Drug: FTC/TDF
Participants receive 200/245 mg of FTC/TDF combination tablet, QD, orally for up to 24 months
Other Names:
Drug: FTC/TAF Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months
Other Names:
Drug: Placebo to ISL Placebo ISL 0 mg tablets QM, orally for up to 24 months. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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.
Information from the National Library of Medicine
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| 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 |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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): NCT04652700
Locations
Show 25 study locations
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
| Study Director: | Medical Director | Merck Sharp & Dohme LLC |
| Responsible Party: | Merck Sharp & Dohme LLC |
| ClinicalTrials.gov Identifier: | NCT04652700 |
| Other Study ID Numbers: |
8591-024 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 |
| Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
| URL: | http://engagezone.msd.com/ds_documentation.php |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Merck Sharp & Dohme LLC:
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Preexposure prophylaxis (PrEP) Prevention |
Additional relevant MeSH terms:
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Infections Tenofovir Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Emtricitabine tenofovir alafenamide Antiviral Agents Anti-Infective Agents |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents |