Study of Novel Antiretrovirals in Participants With HIV-1
NCT ID: NCT05585307
Last Updated: 2025-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2022-10-26
2024-03-18
Brief Summary
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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.
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Detailed Description
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* Substudy-01 enrollment closed, actual enrollment is 13.
* Substudy-02 enrollment closed, actual enrollment is 28.
* Substudy-03 enrollment closed, actual enrollment is 8.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Substudy 01: Cohort 1: Bavtavirine 675 mg (High-Fat Meal)
Participants receive a single dose of bavtavirine 675 mg tablet with a high-fat meal on Day 1. After assessments on Day 11 or upon early termination (ET), the participants initiate a regimen of B/F/TAF, or an alternative standard of care (SOC) antiretroviral (ART) regimen (example INSTI + NRTIs: dolutegravir (DTG)/abacavir (ABC)/3TC or DTG/3TC) up to Day 39.
Bavtavirine
Administered orally
B/F/TAF
Administered orally
Standard of Care (Substudy 01)
Antiretroviral therapy, administered orally
Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
Substudy 01: Cohort 2: Bavtavirine 1200 mg (Low-Fat Meal)
Participants receive a single dose of bavtavirine 1200 mg tablet with a low-fat meal on Day 1. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 39.
Bavtavirine
Administered orally
B/F/TAF
Administered orally
Standard of Care (Substudy 01)
Antiretroviral therapy, administered orally
Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
Substudy 01: Cohort 3: Bavtavirine 900 mg (High-Fat Meal)
Participants receive bavtavirine 900 mg tablet with a high-fat meal on Days 1 and 2. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 39.
Bavtavirine
Administered orally
B/F/TAF
Administered orally
Standard of Care (Substudy 01)
Antiretroviral therapy, administered orally
Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
Substudy 02: Cohort 1: GS-1720 450 mg
Participants receive a single dose of GS-1720 450 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60.
B/F/TAF
Administered orally
GS-1720
Administered orally
Standard of Care (Substudy 02)
Antiretroviral therapy, administered orally
Example INSTIs: DTG/ABC/3TC or DTG/3TC
Substudy 02: Cohort 2: GS-1720 150 mg
Participants receive a single dose of GS-1720 150 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60.
B/F/TAF
Administered orally
GS-1720
Administered orally
Standard of Care (Substudy 02)
Antiretroviral therapy, administered orally
Example INSTIs: DTG/ABC/3TC or DTG/3TC
Substudy 02: Cohort 3: GS-1720 30 mg
Participants receive a single dose of GS-1720 30 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60.
B/F/TAF
Administered orally
GS-1720
Administered orally
Standard of Care (Substudy 02)
Antiretroviral therapy, administered orally
Example INSTIs: DTG/ABC/3TC or DTG/3TC
Substudy 02: Cohort 4: GS-1720 900 mg
Participants receive a single dose of GS-1720 900 mg tablet on both Days 1 and 2 in fasted condition. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 60.
B/F/TAF
Administered orally
GS-1720
Administered orally
Standard of Care (Substudy 02)
Antiretroviral therapy, administered orally
Example INSTIs: DTG/ABC/3TC or DTG/3TC
Substudy 03: Cohort 1: GS- 6212 100 mg
Participants receive GS-6212 100 mg tablet twice daily on Days 1 through 10. After assessments on Day 11 or upon ET, the participants initiate a regimen of B/F/TAF, or an alternative SOC ART regimen (example INSTI + NRTIs: DTG/ABC/3TC or DTG/3TC) up to Day 25.
B/F/TAF
Administered orally
GS-6212
Administered orally
Standard of Care (Substudy 03)
Antiretroviral therapy, administered orally
Interventions
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Bavtavirine
Administered orally
B/F/TAF
Administered orally
Standard of Care (Substudy 01)
Antiretroviral therapy, administered orally
Non-NNRTIs, examples: ABC/DTG/3TC; DTG plus (TAF or TDF) plus (FTC or 3TC)
GS-1720
Administered orally
Standard of Care (Substudy 02)
Antiretroviral therapy, administered orally
Example INSTIs: DTG/ABC/3TC or DTG/3TC
GS-6212
Administered orally
Standard of Care (Substudy 03)
Antiretroviral therapy, administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Long Beach Education and Research Consultants,Substudy-03
Long Beach, California, United States
Mills Clinical Research,Substudy-02
Los Angeles, California, United States
Mills Clinical Research,Substudy-03
Los Angeles, California, United States
Quest Clinical Research,Substudy-01
San Francisco, California, United States
Quest Clinical Research,Substudy-02
San Francisco, California, United States
Quest Clinical Research,Substudy-03
San Francisco, California, United States
Yale University; School of Medicine; AIDS Program (Administrative & Study Supplies),Substudy-03
New Haven, Connecticut, United States
Yale University,Substudy-02
New Haven, Connecticut, United States
Washington Health Institute,Substudy-01
Washington D.C., District of Columbia, United States
Washington Health Institute,Substudy-02
Washington D.C., District of Columbia, United States
Washington Health Institute,Substudy-03
Washington D.C., District of Columbia, United States
Midland Florida Clinical Research Center, LLC,Substudy-02
DeLand, Florida, United States
Midland Florida Clinical Research, LLC,Substudy-03
DeLand, Florida, United States
Midway Immunology and Research Center,Substudy-01
Ft. Pierce, Florida, United States
Midway Immunology and Research Center,Substudy-02
Ft. Pierce, Florida, United States
Midway Immunology and Research Center,Substudy-03
Ft. Pierce, Florida, United States
Bliss Health,Substudy-02
Orlando, Florida, United States
Bliss Health,Substudy-03
Orlando, Florida, United States
Orlando Immunology Center,Substudy-01
Orlando, Florida, United States
Orlando Immunology Center,Substudy-03
Orlando, Florida, United States
Triple O Research Institute, P.A.,Substudy-01
West Palm Beach, Florida, United States
Triple O Research Institute, P.A.,Substudy-03
West Palm Beach, Florida, United States
Infectious Disease Specialists of Atlanta,Substudy-01
Decatur, Georgia, United States
Indiana CTSI Clinical Research Center,Substudy-01
Indianapolis, Indiana, United States
University of Cincinnati College of Medicine,Substudy-02
Cincinnati, Ohio, United States
University of Cincinnati College of Medicine,Substudy-03
Cincinnati, Ohio, United States
Central Texas Clinical Research,Substudy-01
Austin, Texas, United States
Central Texas Clinical Research,Substudy-03
Austin, Texas, United States
Prism Health North Texas,Substudy-02
Dallas, Texas, United States
Prism Health North Texas,Substudy-03
Dallas, Texas, United States
North Texas Infectious Diseases Consultant, P.A.,Substudy-02
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A.,Substudy-03
Dallas, Texas, United States
AXCES Research,Substudy-02
El Paso, Texas, United States
AXES Research Group LLC,Substudy-03
El Paso, Texas, United States
Therapeutic Concepts, PA,Substudy-02
Houston, Texas, United States
Therapeutic Concepts, PA,Substudy-03
Houston, Texas, United States
The Crofoot Research Center, Inc.,Substudy-01
Houston, Texas, United States
MultiCare Rockwood Main Clinic- Research,Substudy-03
Spokane, Washington, United States
Instituto Dominicano de Estudio Virologicos - IDEV,Substudy-02
Santo Domingo, , Dominican Republic
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-02
Bangkok, , Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-03
Bangkok, , Thailand
Faculty of Medicine, Srinagarind Hospital, Khon Kaen University,Substudy-03
Khon Kaen, , Thailand
Countries
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References
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Carl J. Fichtenbaum, Mezgebe Berhe, Jose Bordon, et al, Antiviral Activity, Safety, and Pharmacokinetics of GS-1720: A Novel Weekly Oral INSTI. Conference on Retroviruses and Opportunistic Infections, 2024, 3-6 March.
Provided Documents
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Document Type: Study Protocol: Substudy 01 Protocol Amendment 01
Document Type: Study Protocol: Substudy 02 Protocol Amendment 02
Document Type: Study Protocol: Substudy 03 Protocol Amendment 01
Document Type: Statistical Analysis Plan: Substudy 01 Statistical Analysis Plan
Document Type: Statistical Analysis Plan: Substudy 02 Statistical Analysis Plan
Document Type: Statistical Analysis Plan: Substudy 03 Statistical Analysis Plan
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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GS-US-544-5905
Identifier Type: -
Identifier Source: org_study_id
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