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Integrase Inhibitor

Cabotegravir Tablets for Human Immunodeficiency Virus Infection (SOLAR 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6/5

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new two-drug treatment for HIV that uses long-lasting medications. It aims to see if this new treatment is as effective and safe as the current commonly used treatment. The new drugs work by stopping the virus from multiplying in the body. As HIV has become a manageable chronic condition, there is increased interest in challenging traditional three-drug therapies and moving toward two-drug regimens for initial or maintenance treatment.

Eligible Conditions

Human Immunodeficiency Virus (HIV) Infection
HIV Suppression

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 1) and at month 6/5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 1) and at month 6/5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and at month 6/5 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 HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population

Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population

Secondary study objectives

Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count

Absolute Values of HIV Viral Load

Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L))

+28 more

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

Active Control

Group I: Oral lead-in phase (OLI)Experimental Treatment2 Interventions

Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase

Group II: Direct to injections (D2I)Experimental Treatment2 Interventions

Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.

Group III: Biktarvy (BIK)Active Control1 Intervention

Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).

Group IV: Switch Q2M GroupActive Control2 Interventions

Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rilpivirine Injectable Suspension (RPV LA)

2020

Completed Phase 3

~690

Cabotegravir Injectable Suspension (CAB LA)

2020

Completed Phase 3

~690