Study of Weekly Oral GS-1720 and GS-4182 for Untreated HIV-1 Patients

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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 immune system and can lead to acquired immunodeficiency syndrome (AIDS) if not treated. The study will compare the effectiveness and safety of a new treatment regimen involving two investigational drugs, GS-1720 and GS-4182, taken together once a week, against an existing medication called Biktarvy. Biktarvy is a combination of three active substances: emtricitabine, tenofovir alafenamide, and bictegravir, which is already used to treat HIV-1.

The purpose of the study is to evaluate how well the new weekly treatment works compared to Biktarvy in people who have not received any prior treatment for their HIV-1 infection. Participants in the study will be randomly assigned to receive either the new weekly treatment or Biktarvy. The study will last for up to 48 weeks, during which participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to see if the new treatment can maintain low levels of the virus in the blood, similar to Biktarvy.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study will also collect information on how the new treatment affects the immune system and the levels of the virus in the blood over time. This research is important for developing new treatment options for people living with HIV-1, potentially offering a more convenient weekly dosing schedule compared to daily medication.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the participant is 18 years or older, able to provide informed consent, and has not received antiretroviral treatment, except for specific pre-exposure or post-exposure prophylaxis.

The participant’s HIV-1 RNA levels are measured to ensure they are 500 copies/mL or higher.

2 randomization and treatment assignment

Participants are randomly assigned to one of two treatment groups. One group receives a weekly oral regimen of GS-1720 in combination with GS-4182, while the other group receives Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) daily.

The medications are administered orally in tablet form.

3 treatment phase 2

During Phase 2, the efficacy of the treatments is evaluated over 24 weeks. The primary goal is to determine the proportion of participants with HIV-1 RNA levels below 50 copies/mL at Week 24.

Participants attend regular check-ups to monitor their health and the effectiveness of the treatment.

4 treatment phase 3

In Phase 3, the study continues for an additional 24 weeks, totaling 48 weeks. The primary goal is to evaluate the proportion of participants with HIV-1 RNA levels below 50 copies/mL at Week 48.

Secondary assessments include changes in HIV-1 RNA levels and CD4 cell counts, as well as monitoring for any adverse effects.

5 extended monitoring

For some participants, the study may extend to 96 weeks to further assess the long-term efficacy and safety of the treatments.

Regular monitoring continues, focusing on maintaining HIV-1 RNA levels below 50 copies/mL and observing any long-term effects.

Who Can Join the Study?

Participants must be 18 years of age or older and able to understand and give written informed consent.
Participants assigned male at birth and participants assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception. This means using methods to prevent pregnancy as outlined in the study guidelines.
Participants must have HIV-1 RNA levels of 500 copies/mL or higher at the time of screening. HIV-1 RNA is a measure of the amount of HIV virus in the blood.
Participants must be antiretroviral (ARV) treatment naive, which means they have not received treatment for HIV before, except for the use of oral pre-exposure prophylaxis or post-exposure prophylaxis with specific medications (Truvada® or Descovy®) up to 1 month before screening. These medications are used to prevent HIV infection.

Who Cannot Join the Study?

Individuals who are not diagnosed with HIV-1 Infection cannot participate. HIV-1 Infection is a type of virus that affects the immune system.
Participants who have previously received treatment for HIV-1 Infection are not eligible. This means if you have taken medication for this condition before, you cannot join the study.
People who are not within the specified age range for the study cannot participate. The study is looking for individuals in certain age groups.
Individuals who are not willing or able to follow the study procedures and requirements cannot join. This means you need to be able to attend appointments and take the study medication as directed.
Women who are pregnant or breastfeeding are not eligible to participate. This is to ensure the safety of both the mother and the baby.
Participants with certain other medical conditions that might interfere with the study results are not allowed to join. This is to make sure the study results are accurate and reliable.
Individuals who are part of another clinical trial cannot participate. This is to avoid any interference with the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Clinico San Carlos	Madrid	Spain
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal
Unidade Local De Saude De Lisboa Ocidental E.P.E.	Carnaxide	Portugal
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego	Lodz	Poland
Unidade Local De Saude De Amadora Sintra E.P.E.	Amadora	Portugal
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu	Balotesti	Romania
ICH Study Center GmbH & Co. KG	Hamburg	Germany
Samodzielny Publiczny Wojewodzki Szpital Zespolony W Szczecinie	Szczecin	Poland
Wojewodzki Szpital Zakazny W Warszawie SPZOZ	Warsaw	Poland
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara	Timisoara	Romania
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Institutul National De Boli Infectioase Prof.Dr.Matei Bals	Bucharest	Romania
Spitalul Clinic De Boli Infectioase Constanta	Constanta	Romania
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
Hospital Alvaro Cunqueiro	Vigo	Spain
Uniwersytecki Szpital Dzieciecy W Krakowie	Cracow	Poland
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ufpeixiwgglqqksbgsrfr Egplg Acm	Essen	Germany
Sgnqjqmi Cyfxvx Dm Bvdh Iyrfqprlywm Chspvfdkchn	Cluj Napoca	Romania
Wgftqvfygr Setxkvg Opcoqjphoyzjgfvykdpn Iq Tbnevgaw Bknznfvz	Bydgoszcz	Poland
Pxlgv Zlavats Hjaogatjg Jvljslcqdl Lqmjzfk sob pb	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	18.02.2025
Poland	Not recruiting	18.02.2025
Portugal	Not recruiting	18.02.2025
Romania	Not recruiting	18.02.2025
Spain	Not recruiting	18.02.2025

Trial locations

Investigated drugs:

GS-1720 is an experimental medication being tested for its effectiveness in treating people with HIV-1. It is taken orally once a week and is being studied in combination with another medication, GS-4182, to see how well it works in people who have not received treatment for HIV-1 before.

GS-4182 is another experimental medication used in combination with GS-1720. It is part of a weekly oral treatment regimen being tested for its ability to help control HIV-1 in people who are new to treatment.

Biktarvy is a medication already approved for the treatment of HIV-1. It combines three active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide. It is used as a comparison in the study to evaluate the effectiveness of the new treatment regimen involving GS-1720 and GS-4182.

HIV-1 Infection – HIV-1 infection is caused by the human immunodeficiency virus type 1, which attacks the body’s immune system, specifically the CD4 cells (T cells). Over time, HIV-1 can destroy so many of these cells that the body can’t fight off infections and disease. The virus is transmitted through contact with certain body fluids of an infected person, most commonly during unprotected sex or through sharing needles. Initially, individuals may experience flu-like symptoms, but as the infection progresses, it can lead to more severe immune system damage. Without intervention, HIV-1 can advance to acquired immunodeficiency syndrome (AIDS), where the immune system is severely compromised. The progression of the disease varies among individuals, and it can remain in a latent stage for many years.

Trial ID:

2024-512505-66-00

Protocol code:

GS-US-695-7156

Trial Phase:

Therapeutic use (Phase IV)

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Study of Weekly Oral GS-1720 and GS-4182 for Untreated HIV-1 Patients

What is this study about?

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