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Antiviral

Oral PrEP for HIV Prevention in Women (Impower-022 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
Sexually active (vaginal and/or anal sex) with a male sexual partner in the 30 days prior to screening
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 37 months
Awards & highlights

Impower-022 Trial Summary

This trial will compare the effectiveness of a once-monthly oral medication (islatravir) to a once-daily oral medication (emtricitabine/tenofovir disoproxil) in preventing HIV-1 infection in women.

Who is the study for?
This trial is for cisgender women at high risk of HIV-1 who are sexually active, not pregnant or breastfeeding, and either not able to become pregnant or using birth control. They must be HIV-negative and cannot have a history of certain liver diseases, malignancies within the last 5 years (except some skin cancers), or use of specific long-acting HIV prevention drugs.Check my eligibility
What is being tested?
The study tests if oral Islatravir (ISL) taken monthly is better than daily emtricitabine/tenofovir disoproxil (FTC/TDF) in preventing HIV-1 infection in women at high risk. It compares the effectiveness of ISL against FTC/TDF by looking at new confirmed cases of HIV-1 each year.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, potential impacts on liver health, and other risks typically associated with antiretroviral medications such as gastrointestinal issues, headaches, and fatigue.

Impower-022 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been sexually active with a male partner in the last 30 days.

Impower-022 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 37 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 37 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
Incidence Rate Per Year of Confirmed HIV-1 Infections
Percentage of Participants Who Discontinued Treatment Due to an Adverse Event
Percentage of Participants Who Experienced One or More Adverse Events
Secondary outcome measures
Incidence Rate per Year of Confirmed HIV-1 Infections Among Participants

Side effects data

From 2022 Phase 2 trial • 242 Patients • NCT04003103
10%
Headache
5%
Diarrhoea
5%
Nausea
4%
Upper respiratory tract infection
3%
Abdominal pain
2%
Dizziness
2%
Alanine aminotransferase increased
1%
Loss of consciousness
1%
Blood pressure increased
1%
Intentional self-injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Islatravir 60 mg
Islatravir 120 mg

Impower-022 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ISL QMExperimental Treatment2 Interventions
ISL (islatravir) once monthly AND placebo to FTC/TDF (emtricitabine/tenofovir disoproxil) once daily during Part 1.
Group II: FTC/TDF QDActive Control2 Interventions
FTC/TDF (TRUVADA™ or generic product emtricitabine/tenofovir disoproxil) administered once daily in Parts 1, 2, and 3. Placebo to ISL (islatravir) also administered once monthly during Part 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Islatravir
2020
Completed Phase 2
~410
Placebo to FTC/TDF
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
4,581,181 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,970 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,470 Total Patients Enrolled

Media Library

Islatravir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04644029 — Phase 3
HIV Research Study Groups: ISL QM, FTC/TDF QD
HIV Clinical Trial 2023: Islatravir Highlights & Side Effects. Trial Name: NCT04644029 — Phase 3
Islatravir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04644029 — Phase 3

Frequently Asked Questions

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

Does this research allow for people who are under 55 years old?

"This particular trial is only for patients who are aged 16-45, as that is what the inclusion criteria state. There are 133 clinical trials that have an age limit under 18 and 449 for those over the age of 65."

Answered by AI

What side effects have been documented with Islatravir?

"Islatravir received a safety score of 3 because there is evidence from Phase 3 trials that the drug is effective and that it has been tested multiple times for safety."

Answered by AI

Where can patients go to enroll in this trial?

"Enrolling patients for this clinical trial can be found at Rutgers New jersey Medical School-Clinical Research Center ( Site 0071) in Newark, University of Miami Miller School of Medicine-Infectious disease ( Site 0076) in Miami, Prism Health North Texas, Oak Cliff Health Center ( Site 0070) in Dallas, and 13 other locations."

Answered by AI

What are the primary conditions that Islatravir is used to target?

"Islatravir is mostly used to treat human immunodeficiency virus type 1 (hiv-1), but it can also be useful in managing hiv transmission and infections, as well as human immunodeficiency virus type 1 (hiv-1) infection."

Answered by AI

What other scientific investigations have included Islatravir in their research?

"University of Zurich first studied islatravir in 2002. There have been a total of 440 completed studies on the medication since its inception, with 104 clinical trials currently recruiting patients. Many of these active studies are based in Newark, New jersey."

Answered by AI

Who else is applying?

What state do they live in?
New York
Alabama
How old are they?
18 - 65
What site did they apply to?
University of Alabama at Birmingham-UAB Sexual Health Research Clinic (SHRC) ( Site 0064)
Bronx Prevention Center ICAP ( Site 0062)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~179 spots leftby Mar 2025