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A clinical study of people with HIV-1 who take antiretroviral therapy and switch their treatment to a combination of doravirine and islatravir
EU CTIS ID: 2022-502127-22-00
What this study is testing
1. To evaluate the antiretroviral activity of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), as assessed by the percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) ≥50 copies/mL at Week 48 2. To evaluate the safety and tolerability of a switch to DOR/ISL compared with continued baseline ART, as assessed by review of the safety data accumulated
- 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
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
- Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
- Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator
You likely can't join if
- Has human immunodeficiency virus type 2 (HIV-2) infection
- Has a documented or known virologic resistance to DOR
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B virus (HBV) infection
- Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
See the full eligibility criteria
- Is HIV-1 positive with plasma HIV-1 RNA <50 copies/mL at screening
- Has been receiving continuous, stable oral 2-drug or 3-drug combination (± pharmacokinetic (PK) booster) ART with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
- Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator
- Has human immunodeficiency virus type 2 (HIV-2) infection
- Has a documented or known virologic resistance to DOR
- Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
- Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
- Has active hepatitis B virus (HBV) infection
- Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
- Has a ≤5 years prior history of malignancy
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A) inducers
- Has taken long-acting HIV therapy at any time
- Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Canada
- Japan
- South Africa
- Colombia
- United Kingdom
- Australia
- United States
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Canada; Japan; South Africa; Colombia; United Kingdom and 2 more location(s). 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.