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Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

Try a new weekly HIV treatment in a clinical study.

Recruiting
18 years and older
All
Phase 3

This study is exploring a new treatment plan for people living with HIV-1 who have the virus under control. It will compare a weekly pill containing islatravir and lenacapavir (ISL/LEN), with the usual daily treatment, which includes 2 or 3 antiretroviral agents (ARVs). Participants should have HIV-1 RNA levels below 50 copies/mL for at least 6 months before joining. The main goal is to see if the new treatment works as well as the current one after 48 weeks.

Eligibility requirements include having consistently low HIV-1 levels and being on a stable treatment plan. You can’t join if you’ve had previous treatment failures, have active infections like tuberculosis or hepatitis B, or if you’ve used ISL or LEN before. Females of childbearing age should use approved birth control methods.

  • Study involves switching to a weekly pill, comparing it to daily treatment.
  • Lasts for 48 weeks, with follow-up visits required.
  • Participants must have stable HIV-1 levels and no serious infections.
Study details
    HIV-1-Infection

NCT06630299

Gilead Sciences

8 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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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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