This study is part of a master study. The goal of master protocol (GSUS-544-5905, NCT05585307) is to learn how novel antiretrovirals (medicines that stop the virus from multiplying) affect the human immunodeficiency virus-1 (HIV-1) infection in people living with HIV (PWH). Substudy GS-US-544-5905-04 is to learn more about study drug GS-1219, safety, pharmacokinetics (PK) (how GS-1219 is absorbed, modified, distributed, and removed from the body of the participants), and antiviral activity in Participants With HIV-1.
To refer master study protocol (GS-US-544-5905), refer to NCT05585307 on https://clinicaltrials.gov/
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Administered orally
Administered orally
Antiretroviral therapy, administered orally non nonnucleoside reverse transcriptase inhibitor (NNRTIs), examples: ABC/ DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
Ruane Clinical Research Group
Los Angeles, California, United States
Mills Clinical Research
Los Angeles, California, United States
Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 Copies/mL) at Day 11 Relative to Historical Placebo Data
Time frame: Baseline, Day 11
Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Day 8 Relative to Historical Placebo Data
Time frame: Baseline, Day 8
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: First dose up to Day 25
Percentage of Participants With Graded Laboratory Abnormalities
Time frame: First dose up to Day 25
Pharmacokinetic (PK) Parameter: Cmax of GS-1219
Cmax is defined as the maximum observed concentration of drug.
Time frame: Day 1 Predose up to Day 11
PK Parameter: AUC of GS-1219
AUC is defined as the area under the concentration versus time curve (AUC).
Time frame: Day 1 Predose up to Day 11
PK Parameter: Ct of GS-1219
Ct is defined as the concentration at specified time "t".
Time frame: Any day between Day 1 Predose up to Day 11
Correlation Between Ct and/ or AUC versus the Change in Plasma HIV-1 RNA (Log10 Copies/mL) from Day 1 Through Day 11
Time frame: Day 1 up to Day 11
Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level
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Quest Clinical Research
San Francisco, California, United States
Washington Health Institute
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center
DeLand, Florida, United States
Midway Immunology and Research Center
Ft. Pierce, Florida, United States
BLISS Health Inc
Orlando, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Triple O Research Institute
West Palm Beach, Florida, United States
Be Well Medical Center
Berkley, Michigan, United States
...and 5 more locations
Time frame: Up to Day 11
Percentage of Participants With Emergence of Viral Resistance to the ARV Class of the Given Drug (GS-1219)
Time frame: Up to Day 11