HIV -1 InfectionPhase 1NCT07719491
Study of GS-0415 and How It Works in People With HIV
A Phase 1 study testing GS-0415 in people with HIV -1 Infection, run by Gilead Sciences at 16 sites in United States.
Trial summary
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment. 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-0415
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 16 sitesUnited States
- Study dates
- 22 Jul 2026to Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years and age ≤ 65 years at screening
- On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
- The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
- Plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA <50 copies/mL within the last 12 months.
- Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL
- Weight ≥ 50 kg and ≤ 110 kg at screening and Day 1
- Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening and Day 1
Who cannot join
- Documented history of pre-ART CD4 nadir < 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
- Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
- Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration
- Have chronic hepatitis B virus (HBV) as determined by either:
- Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit
Show all 16Show fewer
- Have active hepatitis C virus (HCV) infection:
- 1.) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
- Have a history of any of the following:
- 2.) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria as assessed by the investigator
- 3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury) as assessed by the investigator
- 4.) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients
- 5.) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia
- 6.) Autoimmune diseases including Type 1 diabetes mellitus
- 7.) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, 30308
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
- Recruiting
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
- Recruiting
Centricity Research CPU - Georgia
Columbus, Georgia, 31904
- Recruiting
The Ohio State University Medical Center Infectious Diseases Clinic
Columbus, Ohio, 43210
- Recruiting
Duke Early Phase Clinical Research Unit
Durham, North Carolina, 27710
- Recruiting
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, 46202
- Recruiting
PPD Development, LP
Las Vegas, Nevada, 89113
- Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
- Recruiting
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
- Not yet recruiting
St. Michaels Medical Center
Newark, New Jersey, 07102
- Recruiting
Jacobi Medical Center
The Bronx, New York, 10461
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
- Recruiting
Triple O Research Institute, P.A.
West Palm Beach, Florida, 33407
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A First-in-Human Phase 1b, Single-Blind, Placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate Safety and Pharmacokinetics of GS-0415 in People With HIV-1 Who Are Virologically Suppressed on Antiretroviral Treatment
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment.
The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.
- Conditions
- HIV -1 Infection
- Being tested
- GS-0415, GS-0415 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-0415Drug
Administered SC or IV
GS-0415 PlaceboDrug
Administered SC or IV
| Study group | Role | What they receive |
|---|---|---|
| Group A Single Ascending Dose (SAD): GS-0415 | Experimental | Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1. Receives: Drug: GS-0415 |
| Group A SAD: Placebo | Experimental | Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. Receives: Drug: GS-0415 Placebo |
| Group B SAD: GS-0415 | Experimental | Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1. Receives: Drug: GS-0415 |
| Group B SAD: Placebo | Experimental | Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. Receives: Drug: GS-0415 Placebo |
| Group C Multiple Ascending Dose (MAD): GS-0415 | Experimental | Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57. Receives: Drug: GS-0415 |
| Group C MAD: Placebo | Experimental | Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57. Receives: Drug: GS-0415 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Measured: First dose date up to 99 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Measured: First dose date up to 99 days
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Measured: Up to 43 days
Serum PK Parameters (SAD): Cmax of GS-0145
Cmax is defined as the maximum observed concentration of drug.
Measured: Up to 43 days
Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Measured: Up to 99 days
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Measured: Up to 99 days
Secondary outcomes (2)
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Measured: Up to 99 days
Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)
Measured: Up to 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start22 Jul 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in SAD cohorts will receive a single dose and participants in the MAD cohorts will receive multiple doses at different time points.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719491
- Sponsor's protocol ID
- GS-US-531-7345
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Phase 1b, Single-Blind, Placebo-controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate Safety and Pharmacokinetics of GS-0415 in People With HIV-1 Who Are Virologically Suppressed on Antiretroviral Treatment
- ClinicalTrials.gov ID
- NCT07719491
- Acronym / sponsor ID
- GS-US-531-7345
- Conditions
- HIV -1 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goals of this clinical study are to learn more about the study drug GS-0415, safety, tolerability, and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of subcutaneous (SC) and intravenous (IV) GS-0415 in people with HIV-1 (PWH) on antiretroviral treatment.
The primary objectives of this study are to evaluate the safety and tolerability of escalating, single and multiple subcutaneous (SC) and intravenous (IV) doses of GS-0415, administered in PWH who are virologically suppressed on antiretroviral therapy (ART) and to evaluate the pharmacokinetics (PK) of GS-0415.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
- Model description
- Participants in SAD cohorts will receive a single dose and participants in the MAD cohorts will receive multiple doses at different time points.
| Arm | Type | Receives |
|---|---|---|
| Group A Single Ascending Dose (SAD): GS-0415 | Experimental | Drug: GS-0415Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1. |
| Group A SAD: Placebo | Experimental | Drug: GS-0415 PlaceboParticipants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. |
| Group B SAD: GS-0415 | Experimental | Drug: GS-0415Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1. |
| Group B SAD: Placebo | Experimental | Drug: GS-0415 PlaceboParticipants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1. |
| Group C Multiple Ascending Dose (MAD): GS-0415 | Experimental | Drug: GS-0415Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57. |
| Group C MAD: Placebo | Experimental | Drug: GS-0415 PlaceboParticipants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and age ≤ 65 years at screening
- On stable antiretroviral (ARV) treatment for ≥ 12 consecutive months prior to screening, throughout the duration of study treatment and follow-up
- The following ARV agents are not allowed as part of the current ART regimen: entry inhibitors (maraviroc, enfuvirtide, ibalizumab, or fostemsavir)
- Plasma HIV-1 RNA < 50 copies/mL for ≥ 12 months before and at screening with at least 2 documented HIV-1 RNA <50 copies/mL within the last 12 months.
- Clusters of differentiation 4 (CD4) count ≥ 350 cells/μL
Key exclusion criteria (16 listed)
- Documented history of pre-ART CD4 nadir < 100 cells/μL. Unknown pre-ART CD4 nadir is acceptable
- Known to have initiated ART within 6 months of HIV infection. Unknown time between infection and ART initiation is acceptable
- Females who are pregnant or breastfeeding or who may wish to become pregnant during the study or within 42 days after last study drug administration
- Have chronic hepatitis B virus (HBV) as determined by either:
- Have active hepatitis C virus (HCV) infection:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-0415Administered SC or IV | Drug | Group A Single Ascending Dose (SAD): GS-0415, Group B SAD: GS-0415, Group C Multiple Ascending Dose (MAD): GS-0415 |
| GS-0415 PlaceboAdministered SC or IV | Drug | Group A SAD: Placebo, Group B SAD: Placebo, Group C MAD: Placebo |
Primary outcome
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
Time frame: First dose date up to 99 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose date up to 99 days
Serum Pharmacokinetic (PK) Parameter (After Single Ascending Dose (SAD)): AUCinf of GS-0145
Time frame: Up to 43 days
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Serum PK Parameters (SAD): Cmax of GS-0145
Time frame: Up to 43 days
Cmax is defined as the maximum observed concentration of drug.
Serum PK Parameters Multiple Ascending Dose (MAD): Dose 1 and Dose 5: AUCtau of GS-0145
Time frame: Up to 99 days
AUCtau is defined as the area under the concentration versus time curve over the dosing interval.
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Time frame: Up to 99 days
2 secondary outcomes
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies
Time frame: Up to 99 days
Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)
Time frame: Up to 99 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-0415 in people with HIV -1 Infection, run by Gilead Sciences at 16 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 7 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) (time frame: First dose date up to 99 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.