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A Phase 3b, open label, randomized, standard-of-care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (CROWN)

Clinical Trial Details

The purpose of this study is to evaluate a potential long-acting injectable HIV treatment option for people whose HIV is not undetectable.

The study drug is a long-acting HIV treatment. It is given by injection every other month after 2 started doses. This is in contrast to oral ART, which is designed to be taken daily.

Participants are randomized to one of two groups. Randomization is like pulling names out of a hat to decide who goes into which group, making sure the selection is fair and unpredictable. There is a 3-in-4 chance of being in Group 1 and a 1-in-4 chance of being in Group 2.

Group 1: Study drug injections once every 2 months after 2 once-monthly started doses

OR

Group 2: Oral ART for 6 months followed by study drug injections once every 2 months after 2 once-monthly starter doses (if HIV is undetectable at month 6). 

The study will last for about 2 years. This will include up to 20 scheduled study visits.

Key Eligibility: 
  1. 18 years of age or older
  2. Living with HIV that is not undetectable
  3. Currently being treated with prescribed oral ART

Detailed eligibility will be discussed when reaching out the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Keisha Ballentine-Cargill, DNP, FNP-BC
212-746-4177
keb4006@med.cornell.edu

Chelsea - Manhattan

Chelsea Clinical Trial Location

Contact(s)

Keisha Ballentine-Cargill, DNP, FNP-BC
212-746-4177
keb4006@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2408027791

ClinicalTrials.gov:

NCT06694805

Sponsor:

221611

Status

Open to Enrollment

Age Group

Adult

Sponsor