← Back to Search

Antiretroviral Therapy

Oral vs Injectable Therapy for HIV (VOLITION Trial)

Phase 3
Recruiting
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 baseline (week 4) and at month 6 and 12
Awards & highlights

VOLITION Trial Summary

This trial will compare two treatments of HIV-1 to see which is more effective and safe, and which patients prefer. Patients will start with one treatment and can switch to another if they wish.

Who is the study for?
Adults with HIV-1 who haven't taken antiretroviral therapy before can join this trial. They must have a certain level of HIV in their blood and be able to consent to the study's requirements. People with severe liver issues, heart conditions, risk of suicide, untreated syphilis or hepatitis B infection, recent exposure to experimental drugs or vaccines, or those on certain medications are excluded.Check my eligibility
What is being tested?
The trial is testing two drug regimens for treating HIV-1: an oral tablet (DTG/3TC) taken daily and long-acting injectable drugs (CAB + RPV LA) given every two months. Participants start with the oral tablet and after viral suppression can choose to switch to injections or continue pills.See study design
What are the potential side effects?
Possible side effects include allergic reactions, liver problems, digestive disturbances, changes in body fat distribution and bone density loss for DTG/3TC; injection site reactions, fever-like symptoms and potential organ damage for CAB + RPV LA.

VOLITION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 4) and at month 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 4) and at month 6 and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
[CAB + RPV LA]: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as per Snapshot Algorithm at Month 11
[DTG/3TC]: Time to Virologic Suppression (HIV-1 Ribonucleic Acid [RNA] <50 Copies per Millilitre [c/mL]) From Baseline (Day 1)
Secondary outcome measures
Absolute Values for Plasma HIV-1 RNA (log10 c/mL) Through Day of choice
Absolute Values in Cluster of Differentiation 4 (CD4+) Cell Count Through Day of Choice
Change From Baseline in Anxiety and Depression Score Using General Anxiety Disorder 7 (GAD-7) Through Day of Choice
+48 more

VOLITION Trial Design

2Treatment groups
Experimental Treatment
Group I: Participants Receiving DTG/3TC Fixed Dose Combination (FDC)Experimental Treatment1 Intervention
Group II: Participants Receiving CAB + RPV LAExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

ViiV HealthcareLead Sponsor
360 Previous Clinical Trials
468,399 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,655 Total Patients Enrolled
PPDIndustry Sponsor
159 Previous Clinical Trials
36,685 Total Patients Enrolled

Media Library

CAB + RPV LA (Antiretroviral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05917509 — Phase 3
Human Immunodeficiency Virus Infection Research Study Groups: Participants Receiving DTG/3TC Fixed Dose Combination (FDC), Participants Receiving CAB + RPV LA
Human Immunodeficiency Virus Infection Clinical Trial 2023: CAB + RPV LA Highlights & Side Effects. Trial Name: NCT05917509 — Phase 3
CAB + RPV LA (Antiretroviral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05917509 — Phase 3

Frequently Asked Questions

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

Have the regulators authorized CAB + RPV LA for patient consumption?

"According to our review, Participants Receiving CAB + RPV LA has been rated 3 out of 3 on the safety scale due to existing clinical evidence that demonstrates efficacy and multiple studies confirming its security."

Answered by AI

How many participants are accepted into this investigation?

"Affirmative, the information publicly available on clinicaltrials.gov indicates that this medical trial is currently recruiting participants. Initially posted on July 6th 2023 and most recently updated July 17th 2023, this study aims to enrol 180 patients from 2 different locations."

Answered by AI

Are new participants being accepted for this research endeavor?

"Affirmative. Information posted on clinicaltrials.gov verifies that this medical endeavour is actively recruiting patients, having been initially listed on July 6th 2023 and recently updated the 17th of July 2023. 180 individuals are sought after at 2 different sites for participation in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy
2023. "A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05917509.
All > Hiv
~108 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top