Oral vs Injectable Therapy for HIV
(VOLITION Trial)

Recruiting in Palo Alto (17 mi)

+60 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ViiV Healthcare

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing two treatments for people with HIV-1 who haven't had previous treatments. Participants start with a pill to manage the virus and may later switch to an injection. The study aims to see how well these treatments work and how patients feel about them.

Eligibility Criteria

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.

Inclusion Criteria

Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category

Participants having plasma HIV-1 RNA ≥1,000 c/mL at Screening

I have never taken antiretroviral drugs before.

+1 more

Exclusion Criteria

Participants with treatment with any of the following agents within 28 days of Screening: radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid, INH), anti-coagulation agents, with the exception of the use of low dose acetylsalicylic acid (≤325 mg), immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. Note: Participants using short-term (e.g. ≤21 days) systemic corticosteroid treatment; topical, inhaled and intranasal corticosteroids are eligible for enrolment, Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening, Treatment with any agent with documented activity against HIV-1 in vitro within 28 days of first dose of study treatment. Treatment with acyclovir/valacyclovir is permitted, Use of medications which are associated with Torsade de Pointes, Participants receiving any protocol-defined prohibited medication and who are unwilling or unable to switch to an alternate medication, Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities, Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant's participation in an interventional clinical trial, Participant has estimated creatine clearance <30 milliliter per minute (mL/min) per 1.73 square meter (m^2) using the refitted, race-neutral Chronic Kidney Disease Epidemiology Collaboration (CKDEPIcr_R) method, Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN); or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35 percentage (%) direct bilirubin), Participants known or suspected to have acquired HIV-1 concurrent with use of protease-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) must be discussed with the Medical Monitor prior to enrolment, Participant has a gluteal implant/enhancements (including fillers); or tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions, Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study drugs, Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant, Participant is currently participating in, or anticipates being selected for, any other interventional study

My liver disease is stable and does not include severe symptoms or conditions.

I do not have untreated syphilis or have completed treatment for it at least 7 days ago.

+17 more

Participant Groups

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.

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