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RPV LA + CAB LA for HIV Prevention in Healthy Participants
Study Summary
This trial is testing the safety and effectiveness of two long-acting HIV medications given either together or alone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 437 Patients • NCT04399551Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I have a history of significant skin conditions like eczema or psoriasis.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that's considered cured.I do not have any major health issues that could affect the study or make it unsafe for me.I am a man who can father children and will use two forms of birth control during and for 72 weeks after the study.I am healthy based on recent physical exams and heart tests.I am allergic to Cabotegravir or its ingredients.I am healthy based on recent physical exams and heart tests.
- Group 1: Panel D: RPV LA
- Group 2: Panel E: RPV LA + Cabotegravir (CAB) LA
- Group 3: Panel A: Rilpivirine (RPV) Long-acting (LA)
- Group 4: Panel B: RPV LA
- Group 5: Panel C: RPV LA
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What medical conditions has RPV LA been demonstrated to improve?
"Patients suffering from HIV-1, who have never been on antiretroviral therapy and weigh at least 35 kg, may be eligible for RPV LA treatment."
Are seniors eligible to join the ongoing research trial?
"This medical trial only allows applicants within the 18-55 age range. In contrast, there are 55 studies for minors and 383 investigations with elderly participants."
What are the projected results of this clinical investigation?
"The principal purpose of this trial, lasting up to 72 weeks, is to ascertain the plasma concentration of cabotegravir. Secondary aims include ascertaining how many patients experience an injection-site reaction and evaluating pain intensity through visual analogue scale (VAS). The study will also collect information on any abnormalities in 12-lead electrocardiograms (ECGs) such as heart rate, PR interval, QRS duration and corrected QT interval (QTc)."
Is recruitment for the trial still open?
"As per clinicaltrials.gov, this trial is actively searching for volunteers to participate in the study. The initial open call was announced on November 16th 2021 and updated recently on November 22nd 2022."
Are there any particular criteria for being eligible to participate in this research?
"This clinical trial is recruiting 135 participants, aged 18 to 55 years old. In order for a potential patient to be eligible, they must pass certain tests and meet the following criteria: women may not donate eggs or freeze them for assisted reproduction during this study; physical examination, medical history check-up, vital signs monitoring and 12-lead electrocardiogram (ECG) must indicate good health; laboratory results should also reflect healthiness; all female participants need to receive negative highly sensitive serum Beta hCG pregnancy test prior to dosing on Day 1; sexually active male candidates without vasectomy are required to use two reliable contraceptive methods throughout the"
What prior investigations have been performed utilizing RPV LA?
"RPV LA was initially examined at University of Zurich in 2002, accumulating a total of 55 completed clinical trials. In the present day, 15 live tests are being conducted with numerous sites located in Salt Lake City, Utah."
How many participants are currently being recruited for this trial?
"Affirmative. The information on clinicaltrials.gov displays that this research, which was published on November 16th 2021, is actively enrolling participants. Currently 135 volunteers are needed to be enrolled from two distinct medical facilities."
What are the potential harms associated with RPV LA?
"Our internal assessment at Power has placed RPV LA's safety on a scale of 1, which is the lowest category. This reflects that this Phase 1 trial only holds limited evidence to support its efficacy and security."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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