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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

Must not have

Unstable liver disease, known biliary abnormalities, history of liver cirrhosis, ongoing or clinically relevant pancreatitis

History or presence of allergy or intolerance to the study drugs or their components or drugs of their class

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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I am over 18, HIV positive, and have never taken antiretroviral therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have liver disease, cirrhosis, pancreatitis, or biliary abnormalities.

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I am allergic to the study drug or similar medications.

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I am not taking any medications known to cause heart rhythm problems.

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I have a serious heart condition.

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I have moderate to severe liver problems.

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I need or will need long-term blood thinners.

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My kidney function is reduced, with a creatinine clearance below 50 mL/min.

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I am not pregnant, breastfeeding, nor planning to during the study.

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I cannot use certain HIV medications due to my HLA-B*5701 status.

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I have tested positive for Hepatitis B.

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My HIV does not show resistance to most NNRTIs or INIs, except K103N.

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I haven't taken any experimental drugs or vaccines recently.

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

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, 41, 2 hours post-dose at weeks 4 and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48

Secondary study objectives

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 more

Other study objectives

Number of Participants With Different Demographic Parameters for Inter-subject Variability

Awards & Highlights

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.

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