← Back to Search

RPV LA + CAB LA for HIV Prevention in Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening (results must be available on Day -1)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 weeks
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of two long-acting HIV medications given either together or alone.

Who is the study for?
Healthy adults who pass a physical exam, ECG, and lab tests can join this trial. Women must not be pregnant and agree not to donate eggs for over 72 weeks post-study. Men with partners able to have children must use two contraceptives during the study and for 72 weeks after.Check my eligibility
What is being tested?
The trial is testing how the body processes a single dose of rilpivirine (RPV) long-acting (LA) alone or combined with cabotegravir (CAB) LA in healthy people. It's also checking if these drugs are safe and tolerable when given under the skin.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site, allergic responses to ingredients, general discomforts like headaches or fatigue, but specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy based on recent physical exams and heart tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma Concentration of Cabotegravir (CAB)
Plasma Concentration of Rilpivirine (RPV)
Secondary outcome measures
Number of Participants With Adverse Events (AEs)
Number of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)
Number of Participants with Injection-Site Reactions
+1 more

Side effects data

From 2023 Phase 3 trial • 437 Patients • NCT04399551
80%
Injection site pain
18%
COVID-19
11%
Injection site induration
10%
Pyrexia
10%
Headache
9%
Injection site discomfort
8%
Back pain
7%
Diarrhoea
7%
Nasopharyngitis
7%
Injection site nodule
6%
Injection site swelling
6%
Asthenia
5%
Arthralgia
5%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patient Study Participants

Trial Design

5Treatment groups
Experimental Treatment
Group I: Panel E: RPV LA + Cabotegravir (CAB) LAExperimental Treatment2 Interventions
Participants will receive one dose of RPV LA (formulation 1) with CAB LA (formulation 3) (Treatment I) on Day 1.
Group II: Panel D: RPV LAExperimental Treatment1 Intervention
Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment G and H) on Day 1, based on interim data of Panel B.
Group III: Panel C: RPV LAExperimental Treatment1 Intervention
Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment E and F) on Day 1, based on interim data of Panel A.
Group IV: Panel B: RPV LAExperimental Treatment1 Intervention
Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment C and D) on Day 1.
Group V: Panel A: Rilpivirine (RPV) Long-acting (LA)Experimental Treatment1 Intervention
Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment A and B) on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPV LA
2018
Completed Phase 3
~540
CAB LA
2018
Completed Phase 3
~650

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,182 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,779 Total Patients Enrolled

Media Library

RPV LA Clinical Trial Eligibility Overview. Trial Name: NCT05112939 — Phase 1
Healthy Subjects Research Study Groups: Panel D: RPV LA, Panel E: RPV LA + Cabotegravir (CAB) LA, Panel A: Rilpivirine (RPV) Long-acting (LA), Panel B: RPV LA, Panel C: RPV LA
Healthy Subjects Clinical Trial 2023: RPV LA Highlights & Side Effects. Trial Name: NCT05112939 — Phase 1
RPV LA 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112939 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Utah
What site did they apply to?
PRA Health Sciences
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Earn extra income and help progress medical science for the better of suffering people.
PatientReceived 1 prior treatment
~0 spots leftby May 2024