BridgeMD
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen
EU CTIS ID: 2022-500929-33-01
What this study is testing
Phase 2: To evaluate the efficacy of switching to a bictegravir (BIC) + lenacapavir (LEN) regimen versus continuing on stable baseline regimen (SBR) in virologically suppressed people with HIV-1 as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 24 Phase 3: To evaluate the efficacy of switching to BIC/LEN fixed-dose combination (FDC) tablet regimen versus continuing on a SBR in virologically suppressed people with HIV-1 as determined by the proportion of participants with HIV--1 RNA ≥ 50 copies/mL at Week 48.
- Phase II and Phase III (Integrated)
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
- Documented plasma human immunodeficiency virus type-1 (HIV-1) ribonucleic acid (RNA) levels must be < 50 copies/mL during treatment with the baseline regimen for a minimum period of 6 months prior to the screening visit (Phase 2 only).
- If plasma HIV-1 RNA measurements in the 6 months prior to screening are available, all levels must be < 50 copies/mL (Phase 3 only).
- Currently receiving a complex antiretroviral (ARV) regimen due to previous viral resistance, or intolerance, or contraindication to the components of existing single-tablet regimens, and on this regimen for at least 6 months prior to the screening visit. The criteria to define a complex regimen in this study are as follows: A regimen containing a boosted protease inhibitor or a nonnucleos(t)ide reverse transcriptase inhibitor (NRTI) plus at least 1 other third agent (ie, an agent from a class other than NRTIs) (eg, bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®)(BVY) + darunavir/cobicistat, BVY + etravirine), or A regimen of ≥ 2 pills/day, or a regimen requiring dosing more than once daily, or A regimen containing parenteral agent(s) (excluding a complete long acting injectable regimen, such as intramuscular cabotegravir plus rilpivirine) as well as oral agents.
- No documented or suspected resistance to bictegravir (BIC).
- Estimated glomerular filtration rate ≥ 15 mL/min according to the Cockcroft- Gault formula for creatinine clearance (CLcr) who are not on renal replacement therapy.
You likely can't join if
- Prior use of, or exposure to, lenacapavir (LEN)
- Active tuberculosis infection
- Chronic hepatitis B virus (HBV) infection
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- South Africa
- Australia
- Canada
- United Kingdom
- Dominican Republic
- Taiwan
- United States
- Japan
- Argentina
- Puerto Rico
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 Korea, Republic of; South Africa; Australia; Canada; United Kingdom; Dominican Republic and 5 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.