Authorised Therapeutic confirmatory (Phase III) Human immunodeficiency virus (HIV)

A study to evaluate the efficacy, safety, and tolerability of using an oral once-daily 2 drug regimen compared to an oral once-daily 3 drug regimen for the treatment of HIV-1 in adults who have not previously taken antiretroviral therapy

EU CTIS ID: 2023-504993-40-00

What this study is testing

To demonstrate the non-inferior antiviral activity of DTG/3TC compared to BIC/FTC/TAF in antiretroviral-naïve PWH.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • All participants eligible for enrolment in the study must meet all of the following criteria: - Age ≥18 years (or older, if required by local regulations) at the time of obtaining informed consent. - Male or female. Female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotropin (hCG) test at Screening and a negative urine hCG test at Enrolment) and not lactating. - Antiretroviral-naïve (no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) PWH. - Participant (or participant’s Legally Acceptable Representative) is capable of giving written informed consent. - Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

You likely can't join if

  • A participant will not be eligible for inclusion in this study if any of the following criteria apply: 1. Pregnant or breastfeeding women or those planning to become pregnant or breastfeed during the study. 2. Active CDC Stage 3 disease is excluded, except for cutaneous Kaposi's sarcoma not needing systemic therapy, and CD4 cell counts below 200 cells/mm3. 3. Previous or current allergy or intolerance to the study treatment, its components, drugs of their class, or other allergies that contraindicate participation. 4. Ongoing or clinically relevant pancreatitis. 5. Ongoing malignancy, except for specific cases agreed upon by the Investigator and Medical Monitor
  • 6. Severe hepatic impairment (Class C) as per Child-Pugh classification. 7. Unstable liver disease or known biliary abnormalities (excluding Gilbert's syndrome, asymptomatic gallstones or stable chronic liver disease). 8. History of liver cirrhosis with or without hepatitis viral co-infection. 9. Alanine aminotransferase (ALT) levels ≥5 times the upper limit of normal (ULN) or ALT ≥3xULN with bilirubin ≥1.5xULN (with >35% direct bilirubin) 10. Significant suicidality risk, based on investigator judgment or history of suicidal behavior or ideation.
  • 11. Signs and symptoms suggestive of active SARS-CoV-2 infection within 14 days before enrolment. 12. Evidence of hepatitis B virus (HBV) infection based on the results of testing at Screening, unless immune. 13. Participants with HCV co-infection are eligible if: liver enzymes meet entry criteria; there is no anticipated requirement for concomitant HCV treatment with potential adverse drug interactions, and HCV disease has undergone appropriate work-up and is not advanced or associated with cirrhosis. 14. Untreated syphilis infection (positive RPR at Screening). Participants ≥7 days post completed treatment are eligible. 15. Major resistance-associated mutations to specified drugs based on resistance guidelines.
  • 16. Recent exposure to experimental drugs or vaccines, meeting protocol-defined conditions, before first dose of study drug. 17. Treatment with radiation therapy, cytotoxic chemotherapeutic agents, or systemic immune suppressants within 28 days of screening. 18. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. 19. Treatment with agents active against HIV-1, except recognized antiretroviral therapy (ART), within 28days of first study dose. 20. Participants receiving protocol-defined prohibited medications who are unwilling or unable to switch to alternate medication
  • 21. Grade 4 laboratory abnormalities, excluding lipid abnormalities. 22. Acute laboratory abnormalities at Screening that, per investigator judgement, preclude participation in a clinical trial. 23. Estimated creatine clearance below 30 mL/min per 1.73 m2 using the refitted, race-neutral CKD-EPIcr_R method 24. Known or suspected acquisition of HIV-1 during either pre-exposure prophylaxis or post-exposure prophylaxis use, requiring consultation with Medical Monitor before enrolment. 25. Conditions affecting drug absorption, distribution, metabolism, or excretion.
  • 26. Pre-existing conditions that may interfere with dosing, protocol compliance, or participant safety. 27. Current or expected participation in another interventional study after randomization, unless pre- approved by the medical monitor

The study team makes the final eligibility decision.

Where it's taking place

  • Israel
  • Japan
  • Argentina
  • Mexico
  • United Kingdom
  • Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Israel; Japan; Argentina; Mexico; United Kingdom; Switzerland. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.