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Integrase Inhibitor

Long-acting Cabotegravir + Rilpivirine for HIV (ATLAS-2M Trial)

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

Subjects receiving oral SOC treatment for HIV-1 must meet specific criteria related to treatment history and viral load

Eligible participants must have been on CAB LA + RPV LA regimen for a minimum of 152 weeks while on the ATLAS-2M study

Must not have

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

Use of medications associated with Torsade de Pointes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is designed to compare the antiviral activity and safety of two regimens of an injectable combination of cabotegravir and rilpivirine given every 8 weeks or every 4 weeks, in adults living with HIV who are currently on a stable antiretroviral regimen.

Who is the study for?

Adults with HIV-1 who have maintained a viral load under 50 copies/mL and been on stable antiretroviral therapy for at least 6 months. Participants must understand the study commitments and be likely to complete them, not be pregnant or breastfeeding, and use effective contraception if of reproductive potential. Those with certain health conditions or taking specific medications are excluded.

What is being tested?

The trial is testing the effectiveness of long-acting injections of Cabotegravir plus Rilpivirine given every two months compared to every month in controlling HIV-1. It includes adults previously treated with standard care or those already receiving these drugs monthly, assessing safety over a year.

What are the potential side effects?

Possible side effects include allergic reactions to the medication components, injection site reactions such as pain or swelling, liver problems indicated by blood tests, potential interactions with other drugs leading to heart issues (like abnormal rhythms), and general symptoms like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on standard HIV-1 treatment and meet specific criteria for treatment history and viral load.

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I have been on the CAB LA + RPV LA treatment for at least 152 weeks as part of the ATLAS-2M study.

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I am 18 years old or older.

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I am able to understand and sign the consent form.

Exclusion Criteria

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

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

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I have used etravirine (ETR) before.

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I am taking medication that is not allowed in the trial and cannot change it.

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

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I do not have serious liver, pancreas, or heart conditions.

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I am currently taking tipranavir/ritonavir or fosamprenavir/ritonavir.

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I have no other cancers except for certain allowed types.

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I have moderate to severe liver problems.

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My cancer has mutations that make it resistant to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose at weeks 4, 8, 13, 24, 32, 40, 48; 1 week post-dose at week 9 and 41 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 Plasma Human Immunodeficiency Virus-ribonucleic Acid (HIV-RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Week 48

Secondary study objectives

AUC for RPV LA

Absolute Values for Cluster of Differentiation 4 Plus (CD4+) at Week 48

Absolute Values for HIV-1 RNA at Week 48

+42 more

Other study objectives

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

Number of Participants With Different Demographic Parameters for Intra-participant Variability

Side effects data

From 2023 Phase 3 trial • 687 Patients • NCT04542070

61%

Injection site pain

19%

COVID-19

11%

Injection site induration

10%

Injection site nodule

10%

Injection site discomfort

10%

Fatigue

10%

Headache

Injection site swelling

Pyrexia

Back pain

Nasopharyngitis

Syphilis

Diarrhoea

Arthralgia

Herpes simplex meningitis

Herpes simplex meningoencephalitis

Overdose

Alanine aminotransferase increased

Substance abuse

Urinary retention

Acute myocardial infarction

Atrial fibrillation

Cholecystitis

Bladder transitional cell carcinoma

Angioedema

100%

80%

60%

40%

20%

Study treatment Arm

Oral lead-in Phase (OLI)

Direct to Injections (D2I)

Biktarvy (BIK)

Switch Q2M Group

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

4Treatment groups

Experimental Treatment

Group I: Subjects in group 2 receiving study treatment once in 8 weeksExperimental Treatment2 Interventions

Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to receive CAB LA plus RPV LA Q8W via IM route.

Group II: Subjects in group 2 receiving study treatment once in 4 weeksExperimental Treatment2 Interventions

Group 2 will consist of subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in Group 2 will be randomized to continue CAB LA plus RPV LA Q4W administration via IM route.

Group III: Subjects in group 1 receiving study treatment once in 8 weeksExperimental Treatment4 Interventions

Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q8W via IM route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.

Group IV: Subjects in group 1 receiving study treatment once in 4 weeksExperimental Treatment4 Interventions

Group 1 will consist of subjects randomized from current ART SOC therapy. Subjects in group 1 will be randomized to receive CAB LA plus RPV LA Q4W via intramuscular (IM) route. All subjects will receive oral therapy with CAB 30 mg + RPV 25 mg once daily prior to randomization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cabotegravir Tablets

2020

Completed Phase 3

~710

Rilpivirine Tablets

2020

Completed Phase 3

~710