AzTrials
AzTrials

HIV-1-infectionPhase 1NCT07001319

Study of GS-3242 in Participants With HIV-1; Substudy-05

A Phase 1 study testing GS-3242 and BVY in people with HIV-1-infection, run by Gilead Sciences at 28 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is part of a master study. The goal of master protocol (GS-US-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-3242 and BVY
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
28 sitesin 3 countries
Study dates
29 May 2025to 16 Apr 2026
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.
Show all 9Show fewer
  • Substudy-05:
  • Willing to initiate BVY provided by the sponsor, or an alternative SOC ART regimen selected by the investigator on Day 11 or upon ET.
  • Participants must also be willing to comply with meal requirements on dosing days.

Who cannot join

  • All Substudies:
  • 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.
Show all 19Show fewer
  • Hepatitis C virus (HCV) antibody positive and detectable HCV RNA.
  • Chronic hepatitis B virus (HBV) infection, as determined by either:
  • 1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit, or
  • 2. 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).
  • Substudy-05:
  • Requirement for ongoing therapy with any prohibited medication.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

28 sites in 3 countries.

28 sites in 3 countries

United States21 sites

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Franco Felizarta, MD

    Bakersfield, California, 93301

  • Be Well Medical Center

    Berkley, Michigan, 48072

  • University of Cincinnati College of Medicine

    Cincinnati, Ohio, 45267

  • Prism Health North Texas

    Dallas, Texas, 75208

  • North Texas Infectious Diseases Consultant's, P.A.

    Dallas, Texas, 75246

  • Midland Florida Clinical Research Center, LLC

    DeLand, Florida, 32720

  • AXCES Research Group, LLC

    El Paso, Texas, 79902

  • AIDS Healthcare Foundation - Northpoint

    Fort Lauderdale, Florida, 33308

  • Midway Immunology & Research Center, LLC

    Ft. Pierce, Florida, 34982

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • KC CARE Health Center

    Kansas City, Missouri, 64111

  • Ruane Clinical Research Group, Inc

    Los Angeles, California, 90036

  • Mills Clinical Research

    Los Angeles, California, 90069

  • BLISS Health

    Orlando, Florida, 32803

  • Orlando Immunology Center, PA

    Orlando, Florida, 32803

  • AXCES Research Group, LLC

    Salt Lake City, Utah, 84102

  • Quest Clinical Research

    San Francisco, California, 94115

  • Chatham County Health Department

    Savannah, Georgia, 31401

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017

  • Triple O Research Institute, P.A.

    West Palm Beach, Florida, 33407

Other trials in United States

Thailand6 sites

  • Institute of HIV Research and Innovation (IHRI)

    Bangkok, 10330

  • Faculty of Medicine Ramathibodi Hospital, Mahidol University

    Bangkok, 10400

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002

  • Bamrasnaradura Infectious Diseases Institute

    Nonthaburi, 11000

  • The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Thai Red Cross AIDS and Infectious Disease Research Center

    Pathumwan, 10330

Other trials in Thailand

Mexico1 site

  • ProcliniQ Investigación Clínica S.A. de C.V

    Mexico City, 6170

Other trials in Mexico

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-05: GS-3242

This study is part of a master study. The goal of master protocol (GS-US-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-544-5905-05 is to learn more about the study drug GS-3242 in PWH.

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-3242, BVY, Standard of Care

What participants receive

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

  • GS-3242Drug

    Administered orally

  • BVYDrug

    Also called Biktarvy®

    Administered orally

  • Standard of CareDrug

    Antiretroviral therapy, administered orally Non-NNRTIs, examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)

Study groups in NCT07001319
Study groupRoleWhat they receive
Cohort 1: Single Dose of GS-3242ExperimentalParticipants 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.
Receives: Drug: GS-3242; 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 39

  3. Percentage of Participants With Graded Laboratory Abnormalities

    Measured: First dose up to Day 39

  4. Pharmacokinetic (PK) Parameter: Cmax of GS-3242

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Day 1 Predose up to Day 11

  5. PK Parameter: AUC of GS-3242

    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-3242

    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-3242)

    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 posted3 Jun 2025
  2. Study start29 May 2025
  3. Primary completion3 Mar 2026
  4. Study completion16 Apr 2026

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
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07001319
Sponsor's protocol ID
GS-US-544-5905-05
Status last verified
May 2026
First submitted
23 May 2025
Last updated
11 May 2026
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-3242 and BVY in people with HIV-1-infection, run by Gilead Sciences at 28 sites in 3 countries.

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 19 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States, Thailand, Mexico. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT07001319.

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 11 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in