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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

Clinical trial comparing weekly HIV pills with daily treatment for suppressed HIV-1.

Recruiting
18 years and older
All
Phase 3

This study is for people with HIV who have stable, low levels of the virus in their blood, referred to as "virologically suppressed" (HIV-1 RNA < 50 copies/mL). It aims to compare two treatment regimens: a new weekly pill made of islatravir and lenacapavir (ISL/LEN), versus the standard daily treatment, bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). The goal is to see if the weekly pill is as effective as the daily one over 48 weeks.

  • Duration: The study lasts 48 weeks.
  • Eligibility: You must have been on B/F/TAF for at least 6 months with stable virus levels. You cannot have had past treatment failures or certain infections like hepatitis B or active hepatitis C.
  • Considerations: Participants will be monitored for safety and effectiveness of the new weekly regimen.

If you are eligible, participation involves regular health check-ups and following the study's guidelines on medication. It's important to discuss with your doctor if joining this study is right for you.

Study details
    HIV-1-infection

NCT06630286

Gilead Sciences

1 March 2025

Step 1 Get in touch with the nearest study center
Entire USA
Results (undefined sites found)
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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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