GS-3242 for HIV

Recruiting at 31 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: 3

Duration: 2 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, GS-3242, to determine its effectiveness in helping people with HIV. The main goal is to assess how well this drug stops the virus from multiplying. Participants will take a single dose of GS-3242 before switching to a standard HIV treatment. Suitable candidates are those living with HIV who have not recently taken any HIV treatments and are willing to follow specific meal plans on dosing days. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial requires that any prescription or over-the-counter medications, except for vitamins, acetaminophen, or ibuprofen, be reviewed and approved by the sponsor. You may need to stop taking certain medications if they are prohibited by the trial protocol.

Is there any evidence suggesting that GS-3242 is likely to be safe for humans?

Research has shown that GS-3242 is under study to determine its safety for people. This new medicine aims to treat HIV by inhibiting the virus's growth. The treatment remains in the early testing stages, so detailed safety information from human trials is not yet available. However, reaching this stage indicates safety in lab and animal studies, a standard step before human testing. Although specific information on side effects or tolerance is not yet available, the early trial phase involves careful monitoring to ensure participant safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

GS-3242 is unique because it offers a potential new approach to HIV treatment by utilizing a single-dose administration. Unlike the standard of care, which often involves daily intake of multiple antiretroviral drugs, GS-3242 could simplify the treatment regimen significantly. This could enhance adherence and improve the quality of life for individuals living with HIV. Researchers are excited about GS-3242 because it might provide a more convenient and potentially more effective way to manage HIV.

What evidence suggests that GS-3242 might be an effective treatment for HIV?

Research has shown that GS-3242, which participants in this trial will receive, is a promising new treatment for HIV-1. GS-3242 belongs to a group of drugs called integrase inhibitors, which help stop the HIV virus from multiplying. Although limited information exists from human studies, early research suggests that integrase inhibitors can effectively lower the amount of HIV in the blood. This indicates that GS-3242 might help people with HIV manage the virus better. As more research is conducted, researchers will better understand how well GS-3242 works. ^{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-1. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of HIV-1 and may need to meet certain health conditions or treatment histories.

Inclusion Criteria

Cluster of differentiation 4 (CD4) cell count > 200 cells/mm^3 at screening

Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening

No clinically significant abnormalities in electrocardiogram (ECG) at screening

Exclusion Criteria

Hepatic transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) > 5 x upper limit of normal (ULN)

Positive serum pregnancy test at screening or a positive pregnancy test prior to Day 1

Individuals with plan to breastfeed during the study period including the protocol-defined follow-up period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of GS-3242 450 mg on Days 1 and 2 in the fasted condition

2 days

2 visits (in-person)

Follow-up

Participants are monitored for pharmacokinetic parameters and safety up to Day 11

9 days

1 visit (in-person) on Day 11

Post-Treatment

Participants initiate a regimen of Biktarvy® or an alternative standard of care antiretroviral regimen up to Day 39

28 days

What Are the Treatments Tested in This Trial?

Interventions

• GS-3242

Trial Overview The study is testing GS-3242, a novel antiretroviral drug designed to inhibit the multiplication of HIV-1 in infected individuals. Participants will also receive standard care, and some may be given an additional drug called BVY.

How Is the Trial Designed?

Group I: Cohort 1: Single Dose of GS-3242 Experimental Treatment 3 Interventions

Participants in cohort 1 will receive single dose of GS-3242 450 mg on Days 1 and 2 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 39. Following the completion of Cohort 1, additional cohorts may be opened for enrollment if further data are needed. Doses of GS-3242 will be based on safety and pharmacokinetic (PK) data from ongoing Phase 1a studies.

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/NCT07001319

NCT07001319 | Study of GS-3242 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=NCT07001319

Study of GS-3242 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-3242). Long-acting injectable. Phase 1. Notes. INSTI – Integrase ... Phase 2 clinical trials study efficacy while also collecting data about safety.

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

The long-acting HIV treatment era is just beginning ... GS-1219 and GS-3242. All these agents are integrase inhibitors; only VH-184 has reached human studies. At HIV Glasgow 2024, Gilead presented ...

5. synapse.patsnap.com synapse.patsnap.com/drug/57aa9e1724d7481284bd2c5f56f5ccef

GS-3242 - Drug Targets, Indications, Patents GS-3242: a HIV-1 integrase inhibitors Drug, Initially developed ... Results showed that twice-yearly lenacapavir cut HIV incidence by 96% .

6. fiercebiotech.com fiercebiotech.com/biotech/gilead-ends-ph-1-trial-after-settling-twice-yearly-treatment-partner-lenacapavir

Gilead settles on twice-yearly treatment partner for ... “We have now chosen to prioritize the development of GS-3242 over GS-1219, and we expect to share more details on GS-3242 at a virology ...