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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
112
Administered SC or IV
Administered SC or IV
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
RECRUITINGGeorgetown University Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGFloridian Clinical Research, LLC
Miami Lakes, Florida, United States
RECRUITINGTriple O Research Institute, P.A.
West Palm Beach, Florida, United States
RECRUITINGEmory University Hospital Midtown Infectious Disease Clinic
Atlanta, Georgia, United States
RECRUITINGCentricity Research CPU - Georgia
Columbus, Georgia, United States
RECRUITINGIndiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGBoston Medical Center
Boston, Massachusetts, United States
RECRUITINGPPD Development, LP
Las Vegas, Nevada, United States
RECRUITING...and 6 more locations
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
AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
Time frame: Up to 43 days
Serum PK Parameters (SAD): Cmax of GS-0145
Cmax is defined as the maximum observed concentration of drug.
Time frame: 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.
Time frame: Up to 99 days
Serum PK Parameters MAD: Dose 1 and Dose 5: Cmax of GS-0145
Time frame: Up to 99 days
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
Gilead Clinical Study Information Center
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