LA-CAB/RPV for HIV Infection

SR
Overseen BySarah Rutstein, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care.

Participants: 40 adult men and women living with HIV will be enrolled

Procedures (methods): This is a pilot, open-label study to evaluate the acceptability, feasibility, and virologic impact of field-based LA-CAB-RPV for PWH who are out of care. This study will enroll 40 participants who accept field-based LA-CAB-RPV, targeting \>50% who reside in rural or semi-rural counties. Participants will be followed for 7 months, with duration of follow-up selected based on the FDA approved every 2 month LA-CAB-RPV injection schedule for virally suppressed patients, aligning with the 5th injection for an every two-month cycle

Who Is on the Research Team?

SR

Sarah Rutstein, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults living with HIV who have stopped regular care. It aims to include people from rural or semi-rural areas. Participants must be willing to try long-acting injectable HIV treatment given outside of a clinic setting.

Inclusion Criteria

Able and willing to provide adequate locator information
HIV-1 infection documented by any licensed rapid HIV test, HIV antibody test, HIV Ag/Ab assay, HIV-1 antigen, plasma HIV-1 RNA viral assay, or care provider in the electronic medical record (EMR)
No documented receipt of HIV care including in person or telemedicine visits in the 9 months prior to screening
See 10 more

Exclusion Criteria

I am currently pregnant or breastfeeding.
I have used LA-CAB/RPV for HIV treatment before.
History of estimated glomerular filtration rate (eGFR) <30 determined by the 2021 CKD-Epi equation
See 15 more

What Are the Treatments Tested in This Trial?

Interventions

  • Cabotegravir/Rilpivirine (LA-CAB/RPV)

Trial Overview

The study tests the use and acceptance of field-based, long-acting cabotegravir/rilpivirine (LA-CAB/RPV) injections every two months for seven months in people with HIV who are out of care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Field-based LA-CAB/RPVExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials
1,588
Recruited
4,364,000+

ViiV Healthcare

Industry Sponsor

Trials
379
Recruited
479,000+
Founded
2009
Headquarters
London, England, UK
Known For
HIV Research
Top Products
- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)
Dr. Harmony Garges profile image

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse profile image

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+