Study Comparing Weekly Islatravir/Lenacapavir Regimen to Standard Care in HIV Patients with Controlled Viral Load

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What is this study about?

This clinical trial is focused on studying the treatment of HIV-1 infection, a virus that attacks the body’s immune system. The study will compare a new treatment option, an oral weekly regimen of Islatravir and Lenacapavir, with the current standard of care for people who have their virus under control, known as being virologically suppressed. The purpose of the study is to evaluate how effective the new treatment is compared to the standard treatment over a period of 48 weeks.

Participants in the study will be randomly assigned to either continue their current standard treatment or switch to the new weekly oral regimen. The study will monitor the participants’ health and the level of the virus in their blood at various points, including at 48 weeks and 96 weeks. The study will also look at changes in the participants’ immune cell counts, specifically CD4 T-cells, which are important for fighting infections.

The study will involve taking medication by mouth, and participants will be closely monitored for any side effects or changes in their health. The trial aims to provide more information on whether the new treatment can be a viable option for people living with HIV-1 who are already managing their condition well with existing treatments.

1 initiation of trial participation

Upon joining the study, participants will be confirmed to have HIV-1 RNA levels below 50 copies/mL, ensuring they are virologically suppressed.

Participants must be receiving standard care treatment for at least six months prior to the start of the trial.

2 randomization and treatment assignment

Participants will be randomly assigned to one of two groups: one group will switch to a weekly oral regimen of islatravir/lenacapavir, while the other group will continue their current standard of care treatment.

3 treatment administration

For those in the islatravir/lenacapavir group, the medication will be taken orally once a week.

Participants continuing with standard care will maintain their current regimen as prescribed.

4 monitoring and assessments

Regular monitoring will occur to assess HIV-1 RNA levels at specified intervals, including at Week 48 and Week 96.

Additional assessments will include changes in CD4 T-cell counts and monitoring for any adverse effects from the treatment.

5 evaluation of primary and secondary endpoints

The primary endpoint is the proportion of participants with HIV-1 RNA levels of 50 copies/mL or more at Week 48.

Secondary endpoints include the proportion of participants with HIV-1 RNA levels below 50 copies/mL at Weeks 48 and 96, changes in CD4 T-cell counts, and the percentage of participants discontinuing the islatravir/lenacapavir regimen due to adverse events.

6 completion of trial participation

Participants will complete the trial after the final assessments at Week 96, with the option to continue their standard care treatment as needed.

Who Can Join the Study?

Participants must be 18 years of age or older and able to understand and give written consent to join the study.
Participants must have HIV-1 RNA levels (a measure of the virus in the blood) of less than 50 copies/mL for at least 6 months before the study starts. This means the virus is well-controlled.
Participants must have HIV-1 RNA levels of less than 50 copies/mL at the time of screening for the study.
Participants must be receiving a standard treatment for HIV, which usually includes 2 or 3 antiretroviral drugs (ARVs), for at least 6 months before the study starts. They must be willing to continue this treatment until the study begins. Some participants may need to continue their treatment for at least 96 weeks.
Individuals who were assigned female at birth and can become pregnant must agree to use specific methods of contraception if they have heterosexual intercourse.
Other specific criteria defined in the study protocol may also apply.

Who Cannot Join the Study?

Patients who are not currently taking medication for HIV-1 infection cannot participate. HIV-1 infection is a type of virus that affects the immune system.
Patients who are not virologically suppressed cannot participate. Virologically suppressed means that the virus is under control and not actively multiplying in the body.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not willing to switch to the new treatment method cannot participate. The study involves changing to a new type of medication.
Patients who are not able to follow the study procedures cannot participate. This means they must be able to attend appointments and take medication as directed.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie	Szczecin	Poland
MVZ Munchen Am Goetheplatz	Munich	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Wroclawskie Centrum Zdrowia Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Wroclaw	Poland
Lmsdw Uolxcdivstew Mgvlzrc Cvdgaup (tndjn	Leiden	The Netherlands
Dkp Sxmidbyd &gsiu Slpfeaihzd Gxg	Cologne	Germany
Mndaqlvktb Ozvxjayaa Pykuaz	Mannheim	Germany
Alsoyejmj Upp	Amsterdam	The Netherlands
Fjddchhui Pjyk La Iwnqqyvsfccjp Btuabhqth Dlo Huhsmisg Upiqkrxjoodsl Lz Pfa	Madrid	Spain
Hxvorndw Uidceytfedogv Hrnagjbf Thhms y Ppdqxv Imjbmhio Cmcarn dyohetnlnluvtxeuz (sois	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	31.01.2025
Poland	Not recruiting	31.01.2025
Spain	Not recruiting	31.01.2025
The Netherlands	Not recruiting	31.01.2025

Trial locations

Investigated drugs:

Islatravir is an investigational medication being studied for its potential use in treating HIV-1. It is designed to be taken orally once a week and works by interfering with the virus’s ability to replicate, helping to control the infection in people who are already virologically suppressed.

Lenacapavir is another investigational medication included in the study. Like Islatravir, it is intended for oral use once a week. Lenacapavir targets a different part of the HIV-1 virus, aiming to prevent it from multiplying and spreading in the body, thereby maintaining viral suppression in individuals with HIV-1.

HIV-1 Infection – Human Immunodeficiency Virus type 1 (HIV-1) is a virus that attacks the immune system, specifically targeting CD4 T-cells, which are crucial for immune defense. Over time, HIV-1 can lead to a significant decrease in CD4 T-cell count, weakening the immune system and making the body more susceptible to infections and certain diseases. The virus is primarily transmitted through contact with infected bodily fluids, such as blood, semen, vaginal fluids, and breast milk. In the early stages, individuals may experience flu-like symptoms, but as the infection progresses, it can remain asymptomatic for years. Without intervention, the continuous decline in immune function can lead to Acquired Immunodeficiency Syndrome (AIDS), characterized by severe immune system damage.

Trial ID:

2024-514047-28-00

Protocol code:

GS-US-563-5926

NCT ID:

NCT06630299

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Weekly Islatravir/Lenacapavir Regimen to Standard Care in HIV Patients with Controlled Viral Load

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?