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Oral PrEP for HIV Prevention in Women (Impower-022 Trial)
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.
Impower-022 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowImpower-022 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 242 Patients • NCT04003103Impower-022 Trial Design
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Who is running the clinical trial?
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- I am not pregnant or breastfeeding and, if capable of becoming pregnant, I am using effective contraception.A WOCBP who wishes to participate in the study must have a negative pregnancy test within 24 hours prior to the first dose of study intervention.I have liver disease.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that didn't spread.I have been sexually active with a male partner in the last 30 days.I have used HIV prevention treatments like cabotegravir or lenacapavir.I am not pregnant or breastfeeding and, if capable of becoming pregnant, I am using effective contraception.There is a high risk for HIV-1 infection.I have been sexually active with a male partner in the last 30 days.
- Group 1: ISL QM
- Group 2: FTC/TDF QD
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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