← Back to Search

Integrase Inhibitor

Cabotegravir Delivery Strategies for HIV Prevention (PILLAR Trial)

Phase 4
Waitlist Available
Research Sponsored by ViiV Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (month 1), month 6 (dti) / month 7 (oli) and month 12 (dti) / month 13 (oli)
Awards & highlights

PILLAR Trial Summary

This trial is testing two ways of delivering a medication to people who may be exposed to HIV, to see if either method is more effective or feasible.

Who is the study for?
This trial is for men who have sex with men and transgender men over 18 in the US, who are HIV negative and haven't used Cabotegravir PrEP before. They must be able to consent to the study. People with an indeterminate or positive HIV test, or those participating in another clinical study during this time cannot join.Check my eligibility
What is being tested?
The study compares two ways of giving Cabotegravir PrEP: one group starts with pills then moves to injections (OLI), while the other goes straight to injections (DTI). It looks at how well each method works in different clinic settings.See study design
What are the potential side effects?
Possible side effects from Cabotegravir include pain or swelling at injection site, headaches, fever, fatigue, sleep problems, stomach issues like nausea or vomiting, and allergic reactions.

PILLAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

PILLAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (month 1), month 6 (dti) / month 7 (oli) and month 12 (dti) / month 13 (oli)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (month 1), month 6 (dti) / month 7 (oli) and month 12 (dti) / month 13 (oli) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Feasibility of Intervention Measure (FIM) Score Assessed from SSPs
Secondary outcome measures
Change From Baseline in AIM Score Assessed from SSPs
Change From Baseline in ISQ Responses Assessed from SSPs
Change from Baseline in AIM Score Assessed from PSPs
+52 more

PILLAR Trial Design

2Treatment groups
Experimental Treatment
Group I: Routine Implementation (RI)Experimental Treatment2 Interventions
PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI) . PSPs and SSPs will have access to standard toolkits for APRETUDE to use as needed.
Group II: Dynamic Implementation (DI)Experimental Treatment2 Interventions
PSPs will receive APRETUDE injection and optional Cabotegravir tablets as oral lead in (OLI). PSPs and SSPs will have access to enhanced toolkits, a digital health implementation strategy and implementation facilitation for APRETUDE to use.

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,427 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,814 Total Patients Enrolled

Media Library

Cabotegravir OLI (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05374525 — Phase 4
Human Immunodeficiency Virus Infection Research Study Groups: Routine Implementation (RI), Dynamic Implementation (DI)
Human Immunodeficiency Virus Infection Clinical Trial 2023: Cabotegravir OLI Highlights & Side Effects. Trial Name: NCT05374525 — Phase 4
Cabotegravir OLI (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374525 — Phase 4

Frequently Asked Questions

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

Are there any restrictions on the number of participants who can join this experiment?

"Affirmative. The clinical trial profile, which first went live on May 18th 2022, hosted by clinicialtrials.gov reveals that the research is actively seeking participants. Approximately 220 patients are required to be recruited from 17 distinct medical establishments."

Answered by AI

What is the scope of this medical trial in terms of clinical implementation?

"The current trial is being hosted at 17 medical centres, with some of the most accessible locations situated in Saint Louis, San Francisco and Boston. To reduce travel costs for participants, it's best to select a clinic close by when signing up."

Answered by AI

To what extent can Cabotegravir OLI put users at risk?

"Due to this being a Phase 4 trial, and thus having prior approval from the relevant governing body, Cabotegravir OLI has been assigned an estimated safety rating of 3."

Answered by AI

Is this clinical trial still open to participants?

"Absolutely, according to clinicaltrials.gov the study is currently recruiting patients. It was first posted on May 18th 2022 and most recently amended October 24th 2022 with an aim of finding 220 participants across 17 distinct sites."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States
2022. "A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374525.
~17 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top