OVERVIEW
An Umbrella Phase 1b, Open-label, Multi-Cohort Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Novel Antiretrovirals in Participants With HIV-1
PROTOCOL SUMMARY
Master protocol: The goal of this master clinical trial study 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-01 (GS-US-544-5905-01) will evaluate bavtavirine in PWH. Substudy-02 (GS-US-544-5905-02) will evaluate GS-1720 in PWH. Substudy-03 (GS-US-544-5905-03) will evaluate GS-6212 in PWH.
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
October 2022 - February 2024
Study Type
Interventional
Study Phase
Phase 1
Product
Bavtavirine, B/F/TAF, Standard of Care (Substudy 01), GS-1720, Standard of Care (Substudy 02), GS-6212, Standard of Care (Substudy 03)
Eligibility information
Inclusion criteria
- All Substudies:
- Plasma human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 5000 copies/mL but ≤ 400,000 copies/mL at screening.
- Cluster of differentiation 4 (CD4) cell count > 200 cells/mm^3 at screening.
- Antiretroviral (ARV) treatment-naive or treatment-experienced but naive to the investigational ARV drug class being investigated in the given substudy and have not received any ARV within 12 weeks of screening, including medications received for pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) (note that current or prior receipt of long acting (LA) parenteral ARVs such as monoclonal antibodies (mAbs) targeting HIV-1, injectable cabotegravir (CAB), or injectable rilpivirine (RPV) is exclusionary).
- Have adequate renal function (estimated glomerular filtration rate (eGFR) ≥ 70 mL/min/1.73 m^2)
- No clinically significant abnormalities in electrocardiogram (ECG) at screening.
- Substudy-01, Substudy-02, and Substudy-03:
- Participants in substudy-01 should be willing to initiate a non-NNRTI based SOC ART on Day 11.
- Participants in substudy-02 and Substudy-03 should be willing to initiate any SOC ART on Day 11.
- Willing and able to comply with meal requirements on dosing days.
Exclusion criteria
- All Substudies:
- Known historical genotypic or phenotypic resistance to 4 major ARV classes (nucleoside reverse transcriptase inhibitor (NRTI), nonnucleoside reverse transcriptase inhibitor (NNRTI), protease inhibitor (PI), integrase strand-transfer inhibitor (INSTI)).
- History of an AIDS-defining condition including present at the time of screening.
- Active, serious infections (other than HIV-1) requiring therapy and including active tuberculosis infection < 30 days prior to randomization.
- History of or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding).
- Any other serious or active clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
- Hepatitis C virus (HCV) antibody positive and detectable HCV RNA.
- Chronic hepatitis B virus (HBV) infection, as determined by either:
- Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit, or
- Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.
- Hepatic transaminases (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) > 5 x upper limit of normal (ULN).
- Current alcohol or substance use judged by the investigator to potentially interfere with individual study compliance.
- Positive serum pregnancy test at screening or a positive pregnancy test prior to Day 1.
- Individuals with plan to breastfeed during the study period including the protocol-defined follow-up period.
- Requirement for ongoing therapy with or prior use of any prohibited medications listed in the protocol. Any prescription medications or over the counter medications, including herbal products, within 28 days prior to start of study drug dosing must be reviewed and approved by the sponsor, with the exception of vitamins and/or acetaminophen and/or ibuprofen.
- Any current or prior receipt of LA parenteral ARVs such as mAbs targeting HIV-1, injectable CAB, or injectable RPV, for treatment or prophylaxis (PrEP, PEP).
- Substudy-01, Substudy-02, Substudy-03:
- Requirement for ongoing therapy with any prohibited medications listed in protocol.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (42)
Long Beach Education and Research Consultants,Substudy-03
Long Beach, California, United States, 90813
Mills Clinical Research,Substudy-02
Los Angeles, California, United States, 90069
Mills Clinical Research,Substudy-03
Los Angeles, California, United States, 90069
Quest Clinical Research,Substudy-01
San Francisco, California, United States, 94115
Quest Clinical Research,Substudy-02
San Francisco, California, United States, 94115
Quest Clinical Research,Substudy-03
San Francisco, California, United States, 94115
Yale University; School of Medicine; AIDS Program (Administrative & Study Supplies),Substudy-03
New Haven, Connecticut, United States, 06510
Yale University,Substudy-02
New Haven, Connecticut, United States, 06520
Washington Health Institute,Substudy-01
Washington D.C., District of Columbia, United States, 20017
Washington Health Institute,Substudy-02
Washington D.C., District of Columbia, United States, 20017
Washington Health Institute,Substudy-03
Washington D.C., District of Columbia, United States, 20017
Midland Florida Clinical Research Center, LLC,Substudy-02
DeLand, Florida, United States, 32720
Midland Florida Clinical Research, LLC,Substudy-03
DeLand, Florida, United States, 32720
Midway Immunology and Research Center,Substudy-01
Ft. Pierce, Florida, United States, 34982
Midway Immunology and Research Center,Substudy-02
Ft. Pierce, Florida, United States, 34982
Midway Immunology and Research Center,Substudy-03
Ft. Pierce, Florida, United States, 34982
Orlando Immunology Center,Substudy-01
Orlando, Florida, United States, 32803
Orlando Immunology Center,Substudy-03
Orlando, Florida, United States, 32803
Triple O Research Institute, P.A.,Substudy-01
West Palm Beach, Florida, United States, 33407
Triple O Research Institute, P.A.,Substudy-03
West Palm Beach, Florida, United States, 33407
Infectious Disease Specialists of Atlanta,Substudy-01
Decatur, Georgia, United States, 30033
Indiana CTSI Clinical Research Center,Substudy-01
Indianapolis, Indiana, United States, 46202
University of Cincinnati College of Medicine,Substudy-02
Cincinnati, Ohio, United States, 45267
University of Cincinnati College of Medicine,Substudy-03
Cincinnati, Ohio, United States, 45267
Central Texas Clinical Research,Substudy-01
Austin, Texas, United States, 78705
Central Texas Clinical Research,Substudy-03
Austin, Texas, United States, 78705
Prism Health North Texas,Substudy-02
Dallas, Texas, United States, 75208
Prism Health North Texas,Substudy-03
Dallas, Texas, United States, 75215
North Texas Infectious Diseases Consultant, P.A.,Substudy-02
Dallas, Texas, United States, 75246
North Texas Infectious Diseases Consultants, P.A.,Substudy-03
Dallas, Texas, United States, 75246
AXES Research Group LLC,Substudy-03
El Paso, Texas, United States, 79902
Therapeutic Concepts, PA,Substudy-02
Houston, Texas, United States, 77004
Therapeutic Concepts, PA,Substudy-03
Houston, Texas, United States, 77004
The Crofoot Research Center, Inc.,Substudy-01
Houston, Texas, United States, 77098
MultiCare Rockwood Main Clinic- Research,Substudy-03
Spokane, Washington, United States, 99202
Instituto Dominicano de Estudio Virologicos - IDEV,Substudy-02
Santo Domingo, Dominican Republic, 10103
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-02
Bangkok, Thailand, 10330
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-03
Bangkok, Thailand, 10330
Faculty of Medicine, Srinagarind Hospital, Khon Kaen University,Substudy-03
Khon Kaen, Thailand, 40002
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