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Integrase Inhibitor
A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (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 12/11
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 12/11
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at month 12/11
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 moreSide effects data
From 2023 Phase 3 trial • 687 Patients • NCT0454207061%
Injection site pain
19%
COVID-19
11%
Injection site induration
10%
Injection site nodule
10%
Injection site discomfort
10%
Fatigue
10%
Headache
9%
Injection site swelling
6%
Pyrexia
6%
Back pain
5%
Nasopharyngitis
5%
Syphilis
5%
Diarrhoea
5%
Arthralgia
1%
Herpes simplex meningitis
1%
Herpes simplex meningoencephalitis
1%
Overdose
1%
Alanine aminotransferase increased
1%
Substance abuse
1%
Urinary retention
1%
Acute myocardial infarction
1%
Atrial fibrillation
1%
Cholecystitis
1%
Bladder transitional cell carcinoma
1%
Angioedema
100%
80%
60%
40%
20%
0%
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
Rilpivirine Tablets
2020
Completed Phase 3
~710
Cabotegravir Tablets
2020
Completed Phase 3
~710
Find a Location
Who is running the clinical trial?
Janssen, LPIndustry Sponsor
168 Previous Clinical Trials
309,698 Total Patients Enrolled
ViiV HealthcareLead Sponsor
373 Previous Clinical Trials
469,726 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,605 Previous Clinical Trials
6,144,384 Total Patients Enrolled