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STATUS Recruitment Complete

Study of Novel Antiretrovirals in Participants With HIV-1

LAST UPDATED

June 6, 2024

Clinicaltrials.gov ID

NCT05585307

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.

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Participation Requirements

Calendar

Age

18 Years - 65 Years

Condition

Sex

All

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

HIV-1-infection

Gender

N/A

Date

October 2022 - March 2027

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

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.
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Exclusion

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.
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Locations

Locations (42)
Other

Long Beach Education and Research Consultants,Substudy-03

Long Beach, California, United States, 90813

Other

Mills Clinical Research,Substudy-02

Los Angeles, California, United States, 90069

Other

Mills Clinical Research,Substudy-03

Los Angeles, California, United States, 90069

Other

Quest Clinical Research,Substudy-01

San Francisco, California, United States, 94115

Other

Quest Clinical Research,Substudy-02

San Francisco, California, United States, 94115

Other

Quest Clinical Research,Substudy-03

San Francisco, California, United States, 94115

Other

Yale University; School of Medicine; AIDS Program (Administrative & Study Supplies),Substudy-03

New Haven, Connecticut, United States, 06510

Other

Yale University,Substudy-02

New Haven, Connecticut, United States, 06520

Other

Washington Health Institute,Substudy-01

Washington, District of Columbia, United States, 20017

Other

Washington Health Institute,Substudy-02

Washington, District of Columbia, United States, 20017

Other

Washington Health Institute,Substudy-03

Washington, District of Columbia, United States, 20017

Other

Midland Florida Clinical Research Center, LLC,Substudy-02

DeLand, Florida, United States, 32720

Other

Midland Florida Clinical Research, LLC,Substudy-03

DeLand, Florida, United States, 32720

Other

Midway Immunology and Research Center,Substudy-01

Fort Pierce, Florida, United States, 34982

Other

Midway Immunology and Research Center,Substudy-02

Fort Pierce, Florida, United States, 34982

Other

Midway Immunology and Research Center,Substudy-03

Fort Pierce, Florida, United States, 34982

Other

Bliss Health,Substudy-02

Orlando, Florida, United States, 32803

Other

Bliss Health,Substudy-03

Orlando, Florida, United States, 32803

Other

Orlando Immunology Center,Substudy-01

Orlando, Florida, United States, 32803

Other

Orlando Immunology Center,Substudy-03

Orlando, Florida, United States, 32803

Other

Triple O Research Institute, P.A.,Substudy-01

West Palm Beach, Florida, United States, 33407

Other

Triple O Research Institute, P.A.,Substudy-03

West Palm Beach, Florida, United States, 33407

Other

Infectious Disease Specialists of Atlanta,Substudy-01

Decatur, Georgia, United States, 30033

Other

Indiana CTSI Clinical Research Center,Substudy-01

Indianapolis, Indiana, United States, 46202

Other

University of Cincinnati College of Medicine,Substudy-02

Cincinnati, Ohio, United States, 45267

Other

University of Cincinnati College of Medicine,Substudy-03

Cincinnati, Ohio, United States, 45267

Other

Central Texas Clinical Research,Substudy-01

Austin, Texas, United States, 78705

Other

Central Texas Clinical Research,Substudy-03

Austin, Texas, United States, 78705

Other

Prism Health North Texas,Substudy-02

Dallas, Texas, United States, 75208

Other

Prism Health North Texas,Substudy-03

Dallas, Texas, United States, 75215

Other

North Texas Infectious Diseases Consultant, P.A.,Substudy-02

Dallas, Texas, United States, 75246

Other

North Texas Infectious Diseases Consultants, P.A.,Substudy-03

Dallas, Texas, United States, 75246

Other

AXCES Research,Substudy-02

El Paso, Texas, United States, 79902

Other

AXES Research Group LLC,Substudy-03

El Paso, Texas, United States, 79902

Other

Therapeutic Concepts, PA,Substudy-02

Houston, Texas, United States, 77004

Other

Therapeutic Concepts, PA,Substudy-03

Houston, Texas, United States, 77004

Other

The Crofoot Research Center, Inc.,Substudy-01

Houston, Texas, United States, 77098

Other

MultiCare Rockwood Main Clinic- Research,Substudy-03

Spokane, Washington, United States, 99202

Other

Instituto Dominicano de Estudio Virologicos - IDEV,Substudy-02

Santo Domingo, Dominican Republic, 10103

Other

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-02

Bangkok, Thailand, 10330

Other

The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),Substudy-03

Bangkok, Thailand, 10330

Other

Faculty of Medicine, Srinagarind Hospital, Khon Kaen University,Substudy-03

Khon Kaen, Thailand, 40002