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

NCT07719491 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GS-US-531-7345
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

Study Arms (6)

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.

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.

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.

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.

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.

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.

Drug: GS-0415 Placebo

Interventions

GS-0415 Placebo DRUG

Administered SC or IV

Group A SAD: Placebo; Group B SAD: Placebo; Group C MAD: Placebo

GS-0415 DRUG

Administered SC or IV

Group A Single Ascending Dose (SAD): GS-0415; Group B SAD: GS-0415; Group C Multiple Ascending Dose (MAD): GS-0415

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Have active hepatitis C virus (HCV) infection:
• ) Positive anti-HCV antibody and negative HCV polymerase chain reaction (PCR) results are acceptable
• Have a history of any of the following:
• ) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria
• ) Significant drug sensitivity or drug allergy ('but not limited to anaphylaxis or drug-induced liver injury)
• ) Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients
• ) Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia
• ) Autoimmune diseases including Type 1 diabetes mellitus
• ) Serious or active medical or psychiatric illness that would interfere with participant treatment, assessment, or compliance with the protocol.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

1-833-445-3230 (GILEAD-0); GileadClinicalTrials@gilead.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in SAD cohorts will receive a single dose and participants in the MAD cohorts will receive multiple doses at different time points.

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share