Study of Weekly Oral GS-1720 and GS-4182 for People with HIV-1 Who Are Virologically Suppressed

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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. The study will compare two different treatment approaches for people whose virus is currently under control. One group will switch to a new weekly oral treatment combining two experimental drugs, GS-1720 and GS-4182. The other group will continue their current daily treatment with Biktarvy, a medication that combines three active ingredients: emtricitabine, tenofovir alafenamide, and bictegravir.

The purpose of the study is to evaluate the effectiveness and safety of the new weekly treatment compared to the existing daily treatment. Participants will be randomly assigned to one of the two groups. The study will be conducted in two phases. In the first phase, the effectiveness of the weekly treatment will be assessed over 24 weeks. In the second phase, the study will continue for up to 48 weeks to further evaluate the long-term effects of the treatments.

Throughout the study, participants will have regular check-ups to monitor their health and the levels of the virus in their blood. The study aims to provide valuable information on whether the new weekly treatment can be a safe and effective alternative to the current daily regimen for people living with HIV-1.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that the HIV-1 RNA level is less than 50 copies/mL for at least 24 weeks before and at the time of screening.

Participants must have been receiving Biktarvy for at least 24 weeks prior to screening.

2 randomization

Participants are randomly assigned to one of two groups: one group continues with the current treatment of Biktarvy, while the other group switches to a new regimen of oral weekly GS-1720 in combination with GS-4182.

3 treatment phase 2

For those switching to the new regimen, GS-1720 and GS-4182 are taken orally once a week. The efficacy of this regimen is evaluated at Week 24.

Participants continuing with Biktarvy maintain their current daily dosage of 50 mg/200 mg/25 mg film-coated tablets.

4 evaluation at week 24

At Week 24, the primary endpoint is assessed. This involves determining the proportion of participants with HIV-1 RNA levels of 50 copies/mL or more.

Secondary endpoints include the proportion of participants with HIV-1 RNA levels below 50 copies/mL and changes in CD4+ T-cell count.

5 treatment phase 3

Participants who continue in the study proceed to Phase 3, where the new regimen of GS-1720 and GS-4182 is evaluated at Week 48.

The same evaluation criteria as in Phase 2 are applied, with additional assessments at Week 96.

6 evaluation at week 48 and 96

At Week 48, the primary endpoint is again assessed, focusing on the proportion of participants with HIV-1 RNA levels of 50 copies/mL or more.

Secondary endpoints include the proportion of participants with HIV-1 RNA levels below 50 copies/mL, changes in CD4+ T-cell count, and the occurrence of any treatment-emergent adverse events.

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 documented plasma HIV-1 RNA levels of less than 50 copies/mL for at least 24 weeks before and at the time of screening. This means their HIV levels in the blood are very low and have been stable for at least 24 weeks.
  • Participants must have been receiving BVY (Biktarvy®) for at least 24 weeks prior to screening. BVY is a medication used to treat HIV.

Who Cannot Join the Study?

  • Individuals who are not virologically suppressed. This means their HIV-1 virus levels are not well controlled by their current treatment.
  • Individuals who are not taking the specific medication called Biktarvy®, which is a combination of three drugs used to treat HIV-1 infection.
  • Individuals who are not able to switch to the new treatment being tested in the study.
  • Individuals who are not within the specified age range for the study.
  • Individuals who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy
Centre Hospitalier Universitaire De Nimes Nimes France
ASST Fatebenefratelli Sacco Milan Italy
Hospital Del Mar Barcelona Spain
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Lodz Poland
Hopital Europeen Marseille Marseille France
zibp Zentrum fuer Infektiologie Berlin Prenzlauer Berg GmbH Berlin Germany
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
Centre Hospitalier Universitaire d’Orléans Orléans France
Ospedale San Raffaele S.r.l. Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Karolinska University Hospital Solna Sweden
IRCCS Ospedale Policlinico San Martino Genoa Italy
Katholisches Klinikum Bochum gGmbH Bochum Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Azienda Sanitaria Locale Citta Di Torino Turin Italy
Servei De Salut De Les Illes Balears Palma Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Soedersjukhuset AB Stockholm Sweden
Upoffmorgzobysyzmaovz Emzbd Atk Essen Germany
Wdmomleuwo Sxbuczq Ofqiuqqxslgliahhuhqa Ir Tevsyrrv Bkvdibfr Bydgoszcz Poland
Sf Zds Shgkmlm Uyllqhtfecvcy w Ktgyfjkd Pnpknyfy Nmfsyuuo Nkmojzuyil Ovutnwooho Cracow Poland
Pipwl Zuutitr Horlbyuhz Jjiagvjftj Ldncgyy sjr ph Gdansk Poland
Mrhbbemkpw Olzorjtsw Pxczko Mannheim Germany
Dzq Ssoyeqgv &imfu Szgqnwmsdr Gsi Cologne Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.12.2024
Germany Germany
Not yet recruiting
02.12.2024
Italy Italy
Not yet recruiting
02.12.2024
Poland Poland
Not yet recruiting
02.12.2024
Spain Spain
Not yet recruiting
02.12.2024
Sweden Sweden
Not yet recruiting
02.12.2024

Trial locations

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 to see if it can maintain viral suppression in patients who are already virologically suppressed.

GS-4182 is another experimental medication used in combination with GS-1720. It is also taken orally once a week. The combination of GS-1720 and GS-4182 is being evaluated to determine if it can effectively maintain viral suppression in people with HIV-1.

Biktarvy is a medication that combines three active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide. It is used to treat HIV-1 and is taken daily. In this study, Biktarvy is used as a comparison to evaluate the effectiveness of the new weekly regimen of 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 can vary greatly among individuals, influenced by factors such as viral load and the individual’s overall health.

Trial ID:
2024-511054-50-00
Protocol code:
GS-US-695-6509
NCT ID:
NCT06544733
Trial Phase:
Therapeutic use (Phase IV)

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