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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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

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 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Treatment
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Georgetown University Medical Center
Washington D.C., District of Columbia 20007

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.