GS-1219 for HIV

No longer recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must not be taking: Long-acting ARVs

Disqualifiers: AIDS, Active infections, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 25 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study a new HIV treatment called GS-1219. Researchers seek to understand how the body absorbs, modifies, and eliminates this drug, as well as its effectiveness against the HIV-1 virus. The trial seeks participants who have HIV-1, have not taken HIV medicines in the last 12 weeks, and have a manageable viral load. Participants must also be willing to follow specific meal plans on dosing days. As a Phase 1 trial, this research focuses on understanding how GS-1219 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that any prescription or over-the-counter medications, including herbal products, be reviewed and approved by the sponsor 28 days before starting the study drug, except for vitamins, acetaminophen, and ibuprofen. This means you might need to stop or adjust some of your current medications.

Is there any evidence suggesting that GS-1219 is likely to be safe for humans?

Research shows that GS-1219 is an experimental treatment for HIV-1, currently in early testing stages. Detailed safety information in humans is not yet available. GS-1219 belongs to a group of drugs called integrase inhibitors, which help stop the virus from multiplying. Other drugs in this group have shown similar safety patterns in the past.

This trial, being in the first phase, focuses on assessing the drug's safety and understanding its effects in the body. Early trials like this typically involve smaller groups to closely monitor any potential side effects. Although specific safety data for GS-1219 is not yet available, reaching this phase indicates some level of safety in lab tests or animal studies. Experts closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard HIV treatments that rely on combinations of antiretroviral drugs like integrase strand transfer inhibitors (INSTIs) and nucleoside reverse transcriptase inhibitors (NRTIs), GS-1219 offers a unique approach. Researchers are excited about GS-1219 because it introduces a new active ingredient with a potentially different mechanism of action, which could enhance treatment options. Additionally, GS-1219 is being explored for its potential to simplify dosing regimens, as it may require fewer doses over a shorter period. This could make it more convenient for patients while maintaining or even improving efficacy.

What evidence suggests that GS-1219 might be an effective treatment for HIV?

Research has shown that GS-1219 is a new HIV treatment known as an integrase inhibitor. These inhibitors block a key enzyme the virus needs to grow. Although detailed human data on GS-1219 remains limited, similar drugs have shown promise in lowering HIV levels. Early results suggest that long-lasting treatments like GS-1219 could better control HIV by maintaining low virus levels over time. This might reduce the number of doses needed, simplifying treatment for patients. The scientific community remains hopeful that GS-1219 will offer a new option for people living with HIV. Participants in this trial will receive GS-1219 in different dosing regimens to evaluate its effectiveness and safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for people living with HIV who have a viral load between 5,000 and 400,000 copies/mL and a CD4 cell count over 200 cells/mm3. Participants should have adequate kidney function, be willing to start treatment provided by the study on Day 11 or earlier if needed, and able to follow meal requirements. Those new to antiretroviral drugs or haven't taken any in the last 12 weeks can join.

Inclusion Criteria

My CD4 cell count is above 200 cells/mm^3.

I can follow the diet plan on treatment days.

I haven't taken HIV drugs recently or only those not being tested in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GS-1219 800 mg once daily on Day 1 through Day 4, and a single dose on Day 7, followed by a regimen of Biktarvy® or alternative ART up to Day 25

25 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GS-1219

Trial Overview The study tests GS-1219's safety, how it's processed by the body (pharmacokinetics), and its effectiveness against HIV-1. It compares GS-1219 with standard HIV treatments (Standard of Care) including BVY. The master protocol oversees this substudy as part of broader research into new anti-HIV drugs.

How Is the Trial Designed?

Group I: Cohort 1 of GS-1219 Experimental Treatment 3 Interventions

Participants in Cohort 1 will receive a single dose of GS-1219 800 mg administered once daily on Day 1 through Day 4, followed by a single dose of GS-1219 800 mg administered on Day 7, all in the fasted condition. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy®) (BVY), or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 25. Following the completion of Cohort 1, additional cohorts may open for enrollment if further data are needed. Participants will receive single or multiple doses of GS-1219 up to 1800 mg administered in the fasted condition or with food (low-fat or high-fat meal).

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07115368

NCT07115368 | Study of GS-1219 in Participants With HIV-1 The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. gileadclinicaltrials.com gileadclinicaltrials.com/study?nctid=NCT07115368

Study of GS-1219 in Participants With HIV-1 All Substudies: · Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening.

3. gilead.com gilead.com/science/pipeline

Virology, Inflammation, & Oncology Pipeline HIV INSTI (GS-1219). Long-acting injectable. Phase 1. Notes. INSTI – Integrase ... Phase 2 clinical trials study efficacy while also collecting data about safety.

4. synapse.patsnap.com synapse.patsnap.com/drug/24daa3f760fd459093786574f7a95308

GS-1219 - Drug Targets, Indications, Patents GS-1219: a HIV-1 integrase inhibitors Drug, Initially developed by Gilead ... Results showed that twice-yearly lenacapavir cut HIV incidence by 96% .

5. hivglasgow.org hivglasgow.org/the-long-acting-hiv-treatment-era-is-just-beginning/

The long-acting HIV treatment era is just beginning At HIV Glasgow 2024, Gilead presented data from a phase 1b study of six-monthly treatment with lenacapavir and two broadly neutralising ...

6. withpower.com withpower.com/trial/phase-1-human-immunodeficiency-virus-type-1-hiv-1-infection-7-2025-2a628

GS-1219 for HIV · Info for Participants This trial is for people living with HIV who have a viral load between 5,000 and 400,000 copies/mL and a CD4 cell count over 200 cells/mm3. Participants should ...