← Back to Search

Integrase Inhibitor

Cabotegravir + Rilpivirine Injections for HIV/AIDS

Phase 3
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
Acceptable stable (initial or second) ARV regimens prior to Screening include specific combinations of drugs
Aged 18 years or older (or ≥19 where required by local regulatory agencies), at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Awards & highlights

Study Summary

This trial is testing whether an injection of two drugs every month can effectively suppress HIV in people who are already taking daily pills to control the virus.

Who is the study for?
Adults over 18 with HIV-1 who've been on a stable antiretroviral regimen for at least 6 months, showing viral suppression. They must not be pregnant or breastfeeding and agree to use effective contraception. Excluded are those with certain medical conditions, history of specific drug use, or participation in other trials.Check my eligibility
What is being tested?
The trial tests if switching from current antiretrovirals to long-acting injections of Cabotegravir and Rilpivirine maintains virus suppression. Participants will either continue their current treatment or switch after an initial oral phase, comparing the efficacy of both methods.See study design
What are the potential side effects?
Possible side effects include injection site reactions, potential liver enzyme changes, allergic reactions to medication components, and general symptoms like fatigue or headaches. Each individual may experience different side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My HIV treatment regimen has been stable before screening.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 week post-dose at weeks 5 and 41
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 week post-dose at weeks 5 and 41 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
Secondary outcome measures
AUC for RPV LA
Absolute Values for CD4+ Lymphocyte Count at Week 48
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
+80 more
Other outcome measures
Number of Participants With Different Demographic Parameters for Inter-subject Variability

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CAB LA + RPV LA every 4 weeksExperimental Treatment4 Interventions
Eligible subjects receive Oral CAB 30 mg + RPV 25 mg once daily for four weeks, IM CAB LA 600 mg and RPV LA 900 mg for the first injection, and Week 4 onwards subjects will receive CAB LA (400 mg) + RPV LA (600 mg) injections every 4 weeks until withdrawal.
Group II: Current antiretroviral regimenActive Control1 Intervention
Eligible subjects will continue their current anti-retroviral regimen (2 NRTIs plus an INI, NNRTI, or a PI) for 52 weeks. After 52 weeks subjects have the option to continue study participation by switching to CAB LA + RPV LA in the Extension Phase where they will follow the procedure of CAB LA + RPV LA arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rilpivirine - Injectable Suspension (RPV LA)
2022
Completed Phase 3
~100
Cabotegravir - Injectable Suspension (CAB LA)
2022
Completed Phase 3
~100
Cabotegravir (CAB) tablet
2020
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
359 Previous Clinical Trials
468,030 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
77 Previous Clinical Trials
172,941 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,742 Previous Clinical Trials
8,062,318 Total Patients Enrolled

Media Library

Cabotegravir (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02951052 — Phase 3
Human Immunodeficiency Virus Infection Research Study Groups: Current antiretroviral regimen, CAB LA + RPV LA every 4 weeks
Human Immunodeficiency Virus Infection Clinical Trial 2023: Cabotegravir Highlights & Side Effects. Trial Name: NCT02951052 — Phase 3
Cabotegravir (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02951052 — Phase 3

Frequently Asked Questions

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

What other medical research has been completed with Cabotegravir - Injectable Suspension (CAB LA)?

"At the current moment, there are 21 ongoing clinical trials evaluating Cabotegravir - Injectable Suspension (CAB LA). Of these 21 active studies, 7 are in Phase 3. The majority of research on this topic is being conducted in Bronx, New york; however, there are 640 total locations running similar investigations."

Answered by AI

What are the risks associated with Cabotegravir - Injectable Suspension (CAB LA)?

"Cabotegravir - Injectable Suspension (CAB LA) is a medication that has received a 3 for safety. This number comes from it being in Phase 3 of trials, where there is some evidence of its efficacy as well as multiple rounds of data supporting its safety."

Answered by AI

What is Cabotegravir - Injectable Suspension (CAB LA) most often used as a remedy for?

"Cabotegravir - Injectable Suspension (CAB LA) is most often used to treat patients that have tested negative for HIV. However, it can also be effective in treating viral resistance, treatment failure, and patients with an HIV-1 RNA of 100,000 copies/ml or less."

Answered by AI

Are there numerous facilities testing this in urban areas?

"There are a total of 36 enrolling sites for this clinical trial, which are situated in Denver, Birmingham, Los Angeles and 33 other cities. To make participation more convenient, it is best to select the location that is closest to you."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
~73 spots leftby Mar 2025