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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 12/11
Awards & highlights

SOLAR Trial Summary

This trial will compare the effectiveness of two different drug regimens for treating HIV. One regimen contains the drugs CAB LA and RPV LA, while the other contains the drug BIKTARVY.

SOLAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 12/11
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 12/11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
59%
Injection site pain
18%
COVID-19
10%
Injection site nodule
10%
Injection site induration
9%
Headache
9%
Fatigue
9%
Injection site discomfort
8%
Injection site swelling
6%
Pyrexia
5%
Diarrhoea
5%
Nasopharyngitis
5%
Syphilis
1%
Angioedema
1%
Cholecystitis
1%
Urinary retention
1%
Herpes simplex meningoencephalitis
1%
Overdose
1%
Herpes simplex meningitis
1%
Bladder transitional cell carcinoma
1%
Back pain
1%
Acute myocardial infarction
1%
Alanine aminotransferase increased
1%
Substance abuse
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral lead-in Phase (OLI)
Direct to Injections (D2I)
Biktarvy (BIK)

SOLAR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving CAB LA + RPV LA regimenExperimental Treatment4 Interventions
Participants will be offered the option to start with a month long oral lead in or to start long acting intramuscular (IM) injections (oral lead in [OLI] or direct to injection [D2I]). On Day 1, participants who choose to participate in OLI will be administered CAB + RPV orally for one month. At the Month 1 visit, last dose of oral CAB + RPV will be given followed by the first CAB LA + RPV LA IM injection. The second IM injection with CAB LA and RPV LA will be administered at Month 2 followed by the same administered every 2 months (Q2M) until Month 12. In D2I, at Day 1, eligible participants will receive the first injection of CAB LA + RPV LA as initial loading dose. The second and third injections (CAB LA + RPV LA) will be administered at Month 1 and Month 3 followed by the same Q2M until Month 11.
Group II: Participants receiving BIKActive Control1 Intervention
Participants will receive BIK, that is a combination of Bictegravir (BIC) + Emtricitabine (FTC) + Tenofovir alafenamide (TAF) orally, administered until Month 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabotegravir Injectable Suspension (CAB LA)
2020
Completed Phase 3
~690
Rilpivirine Tablets
2020
Completed Phase 3
~710
Rilpivirine Injectable Suspension (RPV LA)
2020
Completed Phase 3
~690
Cabotegravir Tablets
2020
Completed Phase 3
~710

Find a Location

Who is running the clinical trial?

Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,303 Total Patients Enrolled
ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
467,892 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorViiV Healthcare
3,595 Previous Clinical Trials
6,143,243 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this the first time Cabotegravir Tablets have been used in a research setting?

"There are 122 separate ongoing clinical trials investigating the efficacy of Cabotegravir Tablets. Of these, 29 are in Phase 3. Most of the trials are situated in Boylston, Massachusetts, but there are 2161 centres running studies for Cabotegravir Tablets in total."

Answered by AI

Are there still available slots that patients can fill in this trial?

"This clinical trial is not admitting patients at the moment. According to the date stamps, this study was first posted on November 9th, 2020 and was most recently edited on October 24th, 2022. However, there are 499 other clinical trials for patients with HIV infections and 122 studies for Cabotegravir Tablets that are admitting patients."

Answered by AI

Are there different areas in the state where this research is being conducted?

"Presently, this trial is underway in 43 hospitals, with sites in New Haven, Syracuse, Dallas, and many others. If you enroll in this study, try to select a location that is close to you to reduce travel burdens."

Answered by AI

What are Cabotegravir Tablets designed to help with?

"Cabotegravir Tablets is most often used to treat anti-retroviral agents, though it is also approved for treatment naive patients, those without resistance to darunavir, and those with human immunodeficiency virus type 1 (hiv-1)."

Answered by AI

Does Cabotegravir Tablets have any harmful side effects?

"There is some data that cabotegravir is effective and it has been tested multiple times for safety, giving it a score of 3."

Answered by AI

How many people are the most that can be enrolled in this experiment?

"As of October 24th, 2022, this clinical trial is not presently looking for patients. This study was first posted on November 9th, 2020. If you are interested in finding other studies, there are 499 trials actively admitting participants with hiv infections and 122 studies for Cabotegravir Tablets actively recruiting patients."

Answered by AI

Who else is applying?

What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
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
2020. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04542070.
~156 spots leftby Apr 2025
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