OVERVIEW
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
PROTOCOL 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.
View moreParticipation requirements
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Age
18 years - 65 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
HIV -1 Infection
Gender
N/A
Date
July 2026 - August 2029
Study Type
Interventional
Study Phase
Phase 1
Product
GS-0415, GS-0415 Placebo
Eligibility information
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.
Locations
Locations (16)
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States, 33016
Triple O Research Institute, P.A.
West Palm Beach, Florida, United States, 33407
Emory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Centricity Research CPU - Georgia
Columbus, Georgia, United States, 31904
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States, 46202
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
St. Michaels Medical Center
Newark, New Jersey, United States, 07102
Duke Early Phase Clinical Research Unit
Durham, North Carolina, United States, 27710
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
The Ohio State University Medical Center Infectious Diseases Clinic
Columbus, Ohio, United States, 43210
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