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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04652700




Registration number
NCT04652700
Ethics application status
Date submitted
2/12/2020
Date registered
3/12/2020

Titles & IDs
Public title
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)
Scientific 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
Secondary ID [1] 0 0
MK-8591-024
Secondary ID [2] 0 0
8591-024
Universal Trial Number (UTN)
Trial acronym
Impower-024
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Preexposure Prophylaxis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ISL
Treatment: Drugs - FTC/TDF
Treatment: Drugs - FTC/TAF
Treatment: Drugs - Placebo to ISL
Treatment: Drugs - Placebo to FTC/TDF
Treatment: Drugs - Placebo to FTC/TAF

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.

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.


Treatment: Drugs: ISL
ISL 60 mg tablet, QM, orally for up to 24 months

Treatment: Drugs: FTC/TDF
Participants receive 200/245 mg of FTC/TDF combination tablet, QD, orally for up to 24 months

Treatment: Drugs: FTC/TAF
Participants receive 200/25 mg of FTC/TAF combination tablet, QD, orally for up to 24 months

Treatment: Drugs: Placebo to ISL
Placebo ISL 0 mg tablets QM, orally for up to 24 months.

Treatment: Drugs: Placebo to FTC/TDF
Placebo FTC/TDF 0 mg tablets QD, orally for up to 24 months

Treatment: Drugs: Placebo to FTC/TAF
Placebo FTC/TAF 0 mg tablets QD, orally for up to 24 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experienced an Adverse Event (AE) During Blinded Treatment
Timepoint [1] 0 0
Up to approximately 10.5 months
Primary outcome [2] 0 0
Number of Participants Who Discontinued From Blinded Study Treatment Due to an AE
Timepoint [2] 0 0
Up to approximately 9 months
Secondary outcome [1] 0 0
Number of Participants With Confirmed HIV-1 Infection
Timepoint [1] 0 0
Up to approximately 10.5 months

Eligibility
Key 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
Minimum age
16 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/08/2023
Sample size
Target
Accrual to date
Final
494
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
France
State/province [12] 0 0
Ile-de-France
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo
Country [14] 0 0
Peru
State/province [14] 0 0
Lima
Country [15] 0 0
South Africa
State/province [15] 0 0
Gauteng
Country [16] 0 0
South Africa
State/province [16] 0 0
Western Cape
Country [17] 0 0
Thailand
State/province [17] 0 0
Krung Thep Maha Nakhon
Country [18] 0 0
Thailand
State/province [18] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04652700