RPV LA for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsRPV LA - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Soticlestat 900 mg
1
Treatment D
1
VEL-101

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 72 weeks

Up to 72 weeks
Number of Participants With Adverse Events (AEs)
Number of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)
Number of Participants with Injection-Site Reactions
Pain Assessment using Visual Analogue Scale (VAS)
Plasma Concentration of Cabotegravir (CAB)
Plasma Concentration of Rilpivirine (RPV)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Soticlestat 900 mg
1
Treatment D
1
VEL-101

Trial Design

5 Treatment Groups

Panel B: RPV LA
1 of 5
Panel E: RPV LA + Cabotegravir (CAB) LA
1 of 5
Panel C: RPV LA
1 of 5
Panel A: Rilpivirine (RPV) Long-acting (LA)
1 of 5
Panel D: RPV LA
1 of 5

Experimental Treatment

135 Total Participants · 5 Treatment Groups

Primary Treatment: RPV LA · No Placebo Group · Phase 1

Panel B: RPV LA
Drug
Experimental Group · 1 Intervention: RPV LA · Intervention Types: Drug
Panel E: RPV LA + Cabotegravir (CAB) LAExperimental Group · 2 Interventions: RPV LA, CAB LA · Intervention Types: Drug, Drug
Panel C: RPV LA
Drug
Experimental Group · 1 Intervention: RPV LA · Intervention Types: Drug
Panel A: Rilpivirine (RPV) Long-acting (LA)
Drug
Experimental Group · 1 Intervention: RPV LA · Intervention Types: Drug
Panel D: RPV LA
Drug
Experimental Group · 1 Intervention: RPV LA · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAB LA
2018
Completed Phase 1
~50

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 72 weeks

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
924 Previous Clinical Trials
6,330,982 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
710 Previous Clinical Trials
3,903,967 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must not donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 72 weeks after receiving the study intervention.
You are a male participant aged 18 years or older who is sexually active with a female of childbearing potential.

Who else is applying?

What state do they live in?
Utah100.0%
What site did they apply to?
PRA Health Sciences100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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