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Antiviral

ISL for PrEP (Impower-024 Trial)

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 26 months
Awards & highlights

Impower-024 Trial Summary

This trial is testing a new once-monthly pill to prevent HIV infection in men who have sex with men and transgender women.

Eligible Conditions
  • PrEP

Impower-024 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 26 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Discontinued Study Treatment Due to an AE
Percentage of Participants Who Experienced an Adverse Event (AE)
Secondary outcome measures
Incidence Rate Per Year of Confirmed HIV-1 infection Among Participants

Side effects data

From 2023 Phase 3 trial • 35 Patients • NCT04233216
29%
Diarrhoea
21%
Lymphocyte count decreased
21%
COVID-19
21%
Creatinine renal clearance decreased
14%
Headache
14%
Fatigue
14%
Nausea
14%
Accidental overdose
14%
Rash
7%
Oropharyngeal pain
7%
Alanine aminotransferase increased
7%
Humerus fracture
7%
C-reactive protein increased
7%
Arthralgia
7%
Motor dysfunction
7%
Hypertension
7%
Intermittent claudication
7%
Proteinuria
7%
Sleep terror
7%
Haematuria
7%
Postoperative wound infection
7%
Urinary tract infection
7%
Pancytopenia
7%
Memory impairment
7%
Dry eye
7%
Intestinal transit time increased
7%
Eye irritation
7%
Skin candida
7%
Upper respiratory tract infection
7%
Obesity
7%
Anaemia
7%
Chest pain
7%
Exposure to communicable disease
7%
Abdominal pain
7%
Mitral valve incompetence
7%
Pyrexia
7%
Blood creatine phosphokinase increased
7%
Amoebiasis
7%
Blood calcium increased
7%
Anaemia postoperative
7%
Blood cholesterol increased
7%
Respiratory tract infection viral
7%
Device dislocation
7%
Blood glucose increased
7%
Myelopathy
7%
Cough
7%
Night sweats
7%
Peripheral arterial occlusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DOR+ART
DOR/ISL+ART
Placebo+ART
ISL+ART

Impower-024 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Islatravir (ISL) Once Monthly (QM) GroupExperimental Treatment3 Interventions
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.
Group II: FTC/TDF or FTC/TAF QD GroupActive Control3 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
ISL
2021
Completed Phase 3
~530
Placebo to FTC/TDF
2021
Completed Phase 3
~500
Placebo to FTC/TAF
2021
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,789 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,887 Previous Clinical Trials
5,054,480 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,370 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are the investigators enrolling in this research project?

"Right now, this study isn't seeking any more enrollees. The trial was first announced on March 15th, 2021 and was last updated on August 15th, 2022. However, if you're interested in other studies, there are 795 active clinical trials for patients with infections and 129 for ISL."

Answered by AI

What is the stance of the FDA on ISL?

"There is some prior clinical data supporting ISL's efficacy, and the drug has undergone multiple rounds of testing to confirm its safety; on our scale, that gives it a score of 3."

Answered by AI

Does research exist on the efficacy of ISL outside of this trial?

"The first study investigating ISL took place in 2002 at the University of Zurich. As of now, there have been 449 completed studies with 129 more currently underway. The majority of these active studies are based in Miami, Florida."

Answered by AI

What are some of the reasons that people often use ISL?

"The most common treatment for patients who are treatment naive is ISL. In addition to adult and pediatric patients weighing at least 40 kg, ISL can also help those who have no resistance to darunavir and human immunodeficiency virus type 1 (hiv-1)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
The Crofoot Research Center ( Site 0025)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04652700.
~121 spots leftby Apr 2025
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