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Integrase Inhibitor
Injectable Cabotegravir + Rilpivirine for HIV
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
HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent
Be older than 18 years old
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, 41, 2 hours post-dose at weeks 4 and 48
Awards & highlights
Study Summary
This trial is testing if two drugs given by injection monthly can keep people with HIV suppressed as well as a current treatment of one pill a day.
Who is the study for?
Adults with HIV-1 who haven't been treated for it before can join this trial. They must have a certain level of virus in their blood and be able to consent to the study's rules. Women can't be pregnant or breastfeeding, and everyone must meet specific contraception requirements. People with severe allergies to study drugs, serious health conditions, or those at risk of suicide are not eligible.Check my eligibility
What is being tested?
The FLAIR study is testing if a long-acting injectable combo (cabotegravir and rilpivirine) keeps HIV suppressed as well as a daily pill regimen does after initial treatment success. Participants will first take pills for 20 weeks; then they'll either continue pills or switch to monthly injections for up to 100 weeks.See study design
What are the potential side effects?
Possible side effects include pain at the injection site, allergic reactions, liver problems, depression or mood changes, stomach issues like nausea or vomiting, fatigue, headaches and muscle pains. The severity of side effects varies from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18, HIV positive, and have never taken antiretroviral therapy.
Timeline
Screening ~ 3 weeks3 visits
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, 41, 2 hours post-dose at weeks 4 and 48
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, 41, 2 hours post-dose at weeks 4 and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage 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
+60 moreOther 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
After Induction Phase with ABC/DTG/3TC (or DTG + two NRTIs), eligible participants will receive oral CAB 30 mg + RPV 25 mg once daily for approximately four weeks. At visit Week 4b subjects will receive an initial loading dose of CAB LA (600 mg) and RPV LA (900 mg) at Week 4b. From Week 8 onwards, subjects will receive CAB LA (400 mg) + RPV LA (600 mg) injections every 4 weeks.
Group II: ABC / DTG / 3TC (600 mg/50mg/300mg) once dailyActive Control2 Interventions
After the Induction Phase with ABC/DTG/3TC (or DTG + two NRTIs), eligible participants will continue to receive oral ABC/DTG/3TC (or DTG + two NRTIs) initiated during the Induction Phase for 100 weeks. At the end of the Maintenance Phase, eligible participants receiving ABC/DTG/3TC (or DTG + two NRTIs) have the option to continue in the study by switching to CAB LA + RPV LA in the Extension Phase. These participants will transition to LA dosing at either Week 100 (direct to inject) or Week 104b (if using optional oral lead-in with CAB 30 mg + RPV 25 mg once daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabotegravir - Injectable Suspension (CAB LA)
2022
Completed Phase 3
~100
Rilpivirine - Injectable Suspension (RPV 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
467,912 Total Patients Enrolled
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
204,440 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,066,821 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, not breastfeeding, and follow the required birth control guidelines.I do not have liver disease, cirrhosis, pancreatitis, or biliary abnormalities.Everyone will be tested for syphilis using a blood test called rapid plasma reagin (RPR).I am at high risk for seizures or have uncontrolled epilepsy.I am allergic to the study drug or similar medications.I am not taking any medications known to cause heart rhythm problems.I have chronic hepatitis C but don't show symptoms, and my doctor is checking if I need specific treatment for it.I have a serious heart condition.I haven't had radiation, chemotherapy, TB therapy (except for latent TB treatment with isoniazid), or immunomodulators in the last 28 days.I have moderate to severe liver problems.I have a tattoo or skin condition on my buttocks that could affect skin reaction assessments.I need or will need long-term blood thinners.I have not had an HIV-1 vaccine in the last 90 days.I haven't taken HIV-1 treatment, except for approved antiretroviral therapy, in the last 28 days.I have taken HIV medication for 10 days or less since my diagnosis.My kidney function is reduced, with a creatinine clearance below 50 mL/min.I am able to understand and willing to sign the consent form for the trial.I do not have any cancer except for certain skin cancers or early-stage cervical, anal, or penile cancer.I don't have any health issues that would affect how my body handles the study drug.Your alanine aminotransferase (ALT) levels are more than three times the upper limit of normal.I am not pregnant, breastfeeding, nor planning to during the study.You have a documented HIV-1 infection with a high level of virus in your blood.I cannot use certain HIV medications due to my HLA-B*5701 status.I don't have severe active infections, except for skin Kaposi's sarcoma not needing systemic treatment.You have a severe abnormality in your lab test results.I have tested positive for Hepatitis B.My HIV does not show resistance to most NNRTIs or INIs, except K103N.I haven't taken any experimental drugs or vaccines recently.I am over 18, HIV positive, and have never taken antiretroviral therapy.
Research Study Groups:
This trial has the following groups:- Group 1: CAB LA + RPV LA every 4 weeks
- Group 2: ABC / DTG / 3TC (600 mg/50mg/300mg) once daily
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary health concerns that Cabotegravir (CAB) tablet addresses?
"The cabotegravir (CAB) tablet is used to treat individuals that have tested negative for HIV. Additionally, it can be used to treat viral resistance, treatment failure, and HIV-1 RNA levels below 100,000 copies/mL."
Answered by AI
Do we have any historical context for the use of Cabotegravir (CAB) tablet in medical trials?
"21 clinical trials are currently ongoing for Cabotegravir. 7 of those are in Phase 3. Though most studies for Cabotegravir are based in Pathum Wan, Bangkok, there are a total of 640 locations running these studies."
Answered by AI
Are there long-term risks to taking Cabotegravir (CAB) tablets?
"There is available clinical evidence affirming Cabotegravir's safety, so it was given a 3."
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
Why did patients apply to this trial?
I want to help out with this trial study.
PatientReceived no prior treatments
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