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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

Must not have

Any switch to a second line regimen due to virologic failure to therapy

Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement ≥50 c/mL

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

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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

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My HIV treatment regimen has been stable before screening.

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I am 18 years old or older.

Exclusion Criteria

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

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My medication was changed due to it not controlling my virus.

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My HIV viral load has been above 50 c/mL after initially being suppressed.

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

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I am not on any excluded ARV regimens.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and at weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 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

Number 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

+80 more

Other study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Cabotegravir - Injectable Suspension (CAB LA)

2022

Completed Phase 3

~100

Rilpivirine - Injectable Suspension (RPV LA)

2022

Completed Phase 3

~100