Global Share

STATUS Recruiting

Study of Novel Antiretrovirals in Participants With HIV-1

LAST UPDATED

February 14, 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 GS-5894 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 - May 2024

Study Type

Interventional

Study Phase

Phase 1

Product

GS-5894, 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 (96)
Withdrawn

Long Beach Education and Research Consultants,Substudy-01

Long Beach, California, United States, 90813

Recruiting

Long Beach Education and Research Consultants,Substudy-02

Long Beach, California, United States, 90813

Recruiting

Long Beach Education and Research Consultants,Substudy-03

Long Beach, California, United States, 90813

Withdrawn

Ruane Clinical Research Group,Substudy-01

Los Angeles, California, United States, 90036

Recruiting

Ruane Clinical Research Group,Substudy-02

Los Angeles, California, United States, 90036

Withdrawn

Mills Clinical Research,Substudy-01

Los Angeles, California, United States, 90069

Recruiting

Mills Clinical Research,Substudy-02

Los Angeles, California, United States, 90069

Recruiting

Mills Clinical Research,Substudy-03

Los Angeles, California, United States, 90069

Withdrawn

BIOS Clinical Research,Substudy-01

Palm Springs, California, United States, 92262

Recruiting

Bios Clinical Research,Substudy-02

Palm Springs, California, United States, 92262

Recruiting

BIOS Clinical Research,Substudy-03

Palm Springs, California, United States, 92262

Study Complete

Quest Clinical Research,Substudy-01

San Francisco, California, United States, 94115

Recruiting

Quest Clinical Research,Substudy-02

San Francisco, California, United States, 94115

Recruiting

Quest Clinical Research,Substudy-03

San Francisco, California, United States, 94115

Recruiting

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

New Haven, Connecticut, United States, 06510

Withdrawn

Yale University,Substudy-01

New Haven, Connecticut, United States, 06520

Recruiting

Yale University,Substudy-02

New Haven, Connecticut, United States, 06520

Study Complete

Washington Health Institute,Substudy-01

Washington, District of Columbia, United States, 20017

Recruiting

Washington Health Institute,Substudy-02

Washington, District of Columbia, United States, 20017

Recruiting

Washington Health Institute,Substudy-03

Washington, District of Columbia, United States, 20017

Withdrawn

Midland Florida Clinical Research Center, LLC,Substudy-01

DeLand, Florida, United States, 32720

Recruiting

Midland Florida Clinical Research Center, LLC,Substudy-02

DeLand, Florida, United States, 32720

Recruiting

Midland Florida Clinical Research, LLC,Substudy-03

DeLand, Florida, United States, 32720

Withdrawn

Therafirst Medical Center,Substudy-01

Fort Lauderdale, Florida, United States, 33308

Withdrawn

Therafirst Medical Center,Substudy-02

Fort Lauderdale, Florida, United States, 33308

Withdrawn

CAN Community Health Care, Inc.,Substudy-02

Fort Lauderdale, Florida, United States, 33316

Withdrawn

Gary J. Richmond, M.D.,P.A.,Substudy-01

Fort Lauderdale, Florida, United States, 33316

Study Complete

Midway Immunology and Research Center,Substudy-01

Fort Pierce, Florida, United States, 34982

Recruiting

Midway Immunology and Research Center,Substudy-02

Fort Pierce, Florida, United States, 34982

Recruiting

Midway Immunology and Research Center,Substudy-03

Fort Pierce, Florida, United States, 34982

Withdrawn

AIDS Healthcare Foundation - South Beach,Substudy-01

Miami Beach, Florida, United States, 33140

Withdrawn

AIDS Healthcare Foundation - South Beach,Substudy-02

Miami Beach, Florida, United States, 33140

Withdrawn

Bliss Health,Substudy-01

Orlando, Florida, United States, 32803

Recruiting

Bliss Health,Substudy-02

Orlando, Florida, United States, 32803

Recruiting

Bliss Health,Substudy-03

Orlando, Florida, United States, 32803

Study Complete

Orlando Immunology Center,Substudy-01

Orlando, Florida, United States, 32803

Recruiting

Orlando Immunology Center,Substudy-02

Orlando, Florida, United States, 32803

Recruiting

Orlando Immunology Center,Substudy-03

Orlando, Florida, United States, 32803

Withdrawn

CAN Community Health,Substudy-01

Sarasota, Florida, United States, 34237

Withdrawn

Can Community Health,Substudy-02

Sarasota, Florida, United States, 34237

Study Complete

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

West Palm Beach, Florida, United States, 33407

Recruiting

Triple O Research Institute, P.A.,Substudy-02

West Palm Beach, Florida, United States, 33407

Recruiting

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

West Palm Beach, Florida, United States, 33407

Withdrawn

Atlanta ID Group, PC,Substudy-01

Atlanta, Georgia, United States, 30309

Withdrawn

Atlanta ID Group, PC,Substudy-02

Atlanta, Georgia, United States, 30309

Study Complete

Infectious Disease Specialists of Atlanta,Substudy-01

Decatur, Georgia, United States, 30033

Recruiting

Infectious Disease Specialists of Atlanta,Substudy-02

Decatur, Georgia, United States, 30033

Recruiting

Infectious Disease Specialists of Atlanta,Substudy-03

Decatur, Georgia, United States, 30033

Withdrawn

Chatham County Health Department,Substudy-01

Savannah, Georgia, United States, 31401

Recruiting

Chatham County Health Department,Substudy-02

Savannah, Georgia, United States, 31401

Recruiting

Chatham County Health Department,Substudy-03

Savannah, Georgia, United States, 31401

Withdrawn

Howard Brown Health Center,Substudy-01

Chicago, Illinois, United States, 60613

Withdrawn

Howard Brown Health Center,Substudy-02

Chicago, Illinois, United States, 60613

Study Complete

Indiana CTSI Clinical Research Center,Substudy-01

Indianapolis, Indiana, United States, 46202

Recruiting

Indiana CTSI Clinical Research Center,Substudy-02

Indianapolis, Indiana, United States, 46202

Recruiting

Indiana CTSI Clinical Research Center,Substudy-03

Indianapolis, Indiana, United States, 46202

Withdrawn

Be Well Medical Center,Substudy-01

Berkley, Michigan, United States, 48072

Withdrawn

Be Well Medical Center,Substudy-02

Berkley, Michigan, United States, 48072

Withdrawn

KC CARE Health Center,Substudy-01

Kansas City, Missouri, United States, 64111

Withdrawn

KC CARE Health Center,Substudy-02

Kansas City, Missouri, United States, 64111

Recruiting

Northwell Health,Substudy-02

Great Neck, New York, United States, 11021

Recruiting

Northwell Health,Substudy-03

Great Neck, New York, United States, 11021

Withdrawn

Northwell Health,Substudy-01

Manhasset, New York, United States, 11030

Withdrawn

University of Cincinnati College of Medicine,Substudy-01

Cincinnati, Ohio, United States, 45267

Recruiting

University of Cincinnati College of Medicine,Substudy-02

Cincinnati, Ohio, United States, 45267

Recruiting

University of Cincinnati College of Medicine,Substudy-03

Cincinnati, Ohio, United States, 45267

Study Complete

Central Texas Clinical Research,Substudy-01

Austin, Texas, United States, 78705

Recruiting

Central Texas Clinical Research,Substudy-02

Austin, Texas, United States, 78705

Recruiting

Central Texas Clinical Research,Substudy-03

Austin, Texas, United States, 78705

Withdrawn

St Hope Foundation Inc.,Substudy-02

Bellaire, Texas, United States, 77401

Withdrawn

St. Hope Foundation, Inc.,Substudy-01

Bellaire, Texas, United States, 77401

Withdrawn

Prism Health North Texas,Substudy-01

Dallas, Texas, United States, 75208

Recruiting

Prism Health North Texas,Substudy-02

Dallas, Texas, United States, 75208

Recruiting

Prism Health North Texas,Substudy-03

Dallas, Texas, United States, 75215

Recruiting

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

Dallas, Texas, United States, 75246

Withdrawn

North Texas Infectious Diseases Consultants, P.A.,Substudy-01

Dallas, Texas, United States, 75246

Recruiting

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

Dallas, Texas, United States, 75246

Withdrawn

AXCES Research,Substudy-01

El Paso, Texas, United States, 79902

Recruiting

AXCES Research,Substudy-02

El Paso, Texas, United States, 79902

Recruiting

AXES Research Group LLC,Substudy-03

El Paso, Texas, United States, 79902

Withdrawn

Therapeutic Concepts, PA,Substudy-01

Houston, Texas, United States, 77004

Recruiting

Therapeutic Concepts, PA,Substudy-02

Houston, Texas, United States, 77004

Recruiting

Therapeutic Concepts, PA,Substudy-03

Houston, Texas, United States, 77004

Study Complete

The Crofoot Research Center, Inc.,Substudy-01

Houston, Texas, United States, 77098

Recruiting

The Crofoot Research, INC,Substudy-02

Houston, Texas, United States, 77098

Recruiting

The Crofoot Research, INC,Substudy-03

Houston, Texas, United States, 77098

Withdrawn

Seattle Infectious Disease Clinic,Substudy-01

Seattle, Washington, United States, 98101

Withdrawn

Seattle Infectious Disease Clinic,Substudy-02

Seattle, Washington, United States, 98101

Withdrawn

MultiCare Rockwood Main Clinic - Research,Substudy-01

Spokane, Washington, United States, 99202

Recruiting

MultiCare Rockwood Main Clinic - Research,Substudy-02

Spokane, Washington, United States, 99202

Recruiting

MultiCare Rockwood Main Clinic- Research,Substudy-03

Spokane, Washington, United States, 99202

Recruiting

Instituto Dominicano de Estudio Virologicos - IDEV,Substudy-02

Santo Domingo, Dominican Republic, 10103

Recruiting

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

Bangkok, Thailand, 10330

Recruiting

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

Bangkok, Thailand, 10330

Recruiting

Faculty of Medicine Ramathibodi Hospital, Mahidol University,Substudy-02

Bangkok, Thailand, 10400

Recruiting

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

Khon Kaen, Thailand, 40002