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HIV-1-infectionPhase 1NCT07115368

Study of GS-1219 in Participants With HIV-1

A Phase 1 study testing GS-1219 and BVY in people with HIV-1-infection, run by Gilead Sciences at 15 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is part of a master study. The goal of master protocol (GSUS-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV-1-infection
What is being tested?
GS-1219 and BVY
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
15 sitesUnited States
Study dates
11 Aug 2025to 2 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All Substudies:
  • Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening.
  • Cluster of differentiation 4 (CD4) cell count > 200 cells/mm^3 at screening.
  • Antiretroviral (ARV) treatment-naive or treatment-experienced but naive to the investigational ARV drug class being investigated in the given substudy and have not received any ARV within 12 weeks of screening, including medications received for pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) (note that current or prior receipt of long acting (LA) parenteral ARVs such as monoclonal antibodies (mAbs) targeting HIV-1, injectable cabotegravir (CAB), injectable rilpivirine (RPV) or injectable Lenacapavir (LEN) is exclusionary).
  • Have adequate renal function (estimated glomerular filtration rate (eGFR) ≥ 70 mL/min/1.73 m^2)
  • No clinically significant abnormalities in electrocardiogram (ECG) at screening.
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  • Substudy-04:
  • Willing to initiate BVY provided by the sponsor, or an alternative SOC ART regimen selected by the investigator on Day 11 or upon ET.
  • Willing and able to comply with meal requirements on dosing days.

Who cannot join

  • Known historical genotypic or phenotypic resistance to 4 major ARV classes (nucleoside reverse transcriptase inhibitor (NRTI), nonnucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand-transfer inhibitor (INSTI)).
  • History of an AIDS-defining condition including present at the time of screening.
  • Active, serious infections (other than HIV-1) requiring therapy and including active tuberculosis infection < 30 days prior to randomization.
  • History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
  • Any other serious or active clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
  • Hepatitis C virus (HCV) antibody positive and detectable HCV RNA.
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  • Chronic hepatitis B virus (HBV) infection, as determined by either:
  • Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit, or
  • Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
  • Hepatic transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) > 5 x upper limit of normal (ULN).
  • Current alcohol or substance use judged by the investigator to potentially interfere with individual study compliance.
  • 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.
  • Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. Any prescription medications or over the counter medications, including herbal products, within 28 days prior to start of study drug dosing must be reviewed and approved by the sponsor, with the exception of vitamins and/or acetaminophen and/or ibuprofen.
  • Any current or prior receipt of LA parenteral ARVs such as mAbs targeting HIV-1, injectable CAB, or injectable RPV, or injectable LEN, for treatment or prophylaxis (PrEP, PEP).
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • Prism Health North Texas

    Dallas, Texas, 75208

  • North Texas Infectious Diseases Consultants

    Dallas, Texas, 75246

  • Midland Florida Clinical Research Center

    DeLand, Florida, 32720

  • AXCES Research Group

    El Paso, Texas, 79902

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • Ruane Clinical Research Group

    Los Angeles, California, 90036

  • Mills Clinical Research

    Los Angeles, California, 90069

  • BLISS Health Inc

    Orlando, Florida, 32803

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • AXCES Research Group

    Salt Lake City, Utah, 84102

  • Quest Clinical Research

    San Francisco, California, 94115

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017

  • Triple O Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1; Substudy-04: GS-1219

This study is part of a master study. The goal of master protocol (GSUS-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH).

Substudy GS-US-544-5905-04 is to learn more about study drug GS-1219, safety, pharmacokinetics (PK) (how GS-1219 is absorbed, modified, distributed, and removed from the body of the participants), and antiviral activity in Participants With HIV-1.

Read the detailed description

To refer master study protocol (GS-US-544-5905), refer to NCT05585307 on https://clinicaltrials.gov/

Conditions
HIV-1-infection
Being tested
GS-1219, BVY, Standard of Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GS-1219Drug

    Administered orally

  • BVYDrug

    Also called Biktarvy®

    Administered orally

  • Standard of CareDrug

    Antiretroviral therapy, administered orally non nonnucleoside reverse transcriptase inhibitor (NNRTIs), examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Study groups in NCT07115368
Study groupRoleWhat they receive
Cohort 1 of GS-1219ExperimentalParticipants 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).
Receives: Drug: GS-1219; Drug: BVY; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data

    Measured: Baseline, Day 11

Secondary outcomes (9)

  1. Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data

    Measured: Baseline, Day 8

  2. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: First dose up to Day 25

  3. Percentage of Participants With Graded Laboratory Abnormalities

    Measured: First dose up to Day 25

  4. Pharmacokinetic (PK) Parameter: Cmax of GS-1219

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Day 1 Predose up to Day 11

  5. PK Parameter: AUC of GS-1219

    AUC is defined as the area under the concentration versus time curve (AUC).

    Measured: Day 1 Predose up to Day 11

  6. PK Parameter: Ct of GS-1219

    Ct is defined as the concentration at specified time "t".

    Measured: Any day between Day 1 Predose up to Day 11

  7. Correlation Between Ct and/ or AUC versus the Change in Plasma HIV-1 RNA (Log10 Copies/mL) from Day 1 Through Day 11

    Measured: Day 1 up to Day 11

  8. Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level

    Measured: Up to Day 11

  9. Percentage of Participants With Emergence of Viral Resistance to the ARV Class of the Given Drug (GS-1219)

    Measured: Up to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start11 Aug 2025
  3. Primary completion19 Sep 2025
  4. Study completion2 Oct 2025

Why it stopped: Sponsor decision to terminate study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07115368
Sponsor's protocol ID
GS-US-544-5905-04
Status last verified
Oct 2025
First submitted
4 Aug 2025
Last updated
21 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GS-1219 and BVY in people with HIV-1-infection, run by Gilead Sciences at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision to terminate study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data (time frame: Baseline, Day 11). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07115368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.

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