Study of GS-0415 and How It Works in People With HIV

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV -1 Infection
• Intervention / Treatment: Drug: GS-0415; Drug: GS-0415 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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 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

Key Exclusion Criteria:

• 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:

  1. Positive HBV surface antigen, regardless of HBV core antibody status, at the Screening visit
  2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the Screening visit

• 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

  3.) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury)

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Single Ascending Dose (SAD): GS-0415; Participants will receive single escalating doses of GS-0415 via subcutaneous (SC) or intravenously (IV) on Day 1.	Drug: GS-0415; Administered SC or IV
Experimental: Group A SAD: Placebo; Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.	Drug: GS-0415 Placebo; Administered SC or IV
Experimental: Group B SAD: GS-0415; Participants will receive single escalating doses of GS-0415 via SC or IV on Day 1.	Drug: GS-0415; Administered SC or IV
Experimental: Group B SAD: Placebo; Participants will receive placebo to match the single escalating doses of GS-0415 via SC or IV on Day 1.	Drug: GS-0415 Placebo; Administered SC or IV
Experimental: Group C Multiple Ascending Dose (MAD): GS-0415; Participants will receive escalating doses of GS-0415 via SC or IV at five different timepoints up to Date 57.	Drug: GS-0415; Administered SC or IV
Experimental: Group C MAD: Placebo; Participants will receive placebo to match escalating doses of GS-0415 via SC or IV at five different timepoints up to Day 57.	Drug: GS-0415 Placebo; Administered SC or IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)		First dose date up to 99 days
Percentage of Participants Experiencing Clinical Laboratory Abnormalities		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).	Up to 43 days
Serum PK Parameters (SAD): Cmax of GS-0145	Cmax is defined as the maximum observed concentration of drug.	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.	Up to 99 days
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145		Up to 99 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentages of participants With of Treatment-Emergent Anti-GS-0415 Antibodies	Up to 99 days
Percentages of participants With Virological Rebound (Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 copies/mL)	Up to 99 days

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: July 17, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: GS-US-531-7345

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No