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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05585307
Other study ID # GS-US-544-5905
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date October 26, 2022
Est. completion date March 2027

Study information

Verified date June 2024
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This umbrella study will begin with a substudy of bavtavirine (Substudy-01), and new substudies may be added in the future. Substudies evaluating additional study drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. - Substudy-01 enrollment closed, actual enrollment is 13. - Substudy-02 enrollment closed, actual enrollment is 28. - Substudy-03 enrollment closed, actual enrollment is 8.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 49
Est. completion date March 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Key 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. Key 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Dominican Republic Instituto Dominicano de Estudio Virologicos - IDEV,Substudy-02 Santo Domingo
Thailand 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
United States Central Texas Clinical Research,Substudy-01 Austin Texas
United States Central Texas Clinical Research,Substudy-03 Austin Texas
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 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 Prism Health North Texas,Substudy-02 Dallas Texas
United States Prism Health North Texas,Substudy-03 Dallas Texas
United States Infectious Disease Specialists of Atlanta,Substudy-01 Decatur Georgia
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 AXCES Research,Substudy-02 El Paso Texas
United States AXES Research Group LLC,Substudy-03 El Paso Texas
United States Midway Immunology and Research Center,Substudy-01 Fort Pierce Florida
United States Midway Immunology and Research Center,Substudy-02 Fort Pierce Florida
United States Midway Immunology and Research Center,Substudy-03 Fort Pierce Florida
United States The Crofoot Research Center, Inc.,Substudy-01 Houston Texas
United States Therapeutic Concepts, PA,Substudy-02 Houston Texas
United States Therapeutic Concepts, PA,Substudy-03 Houston Texas
United States Indiana CTSI Clinical Research Center,Substudy-01 Indianapolis Indiana
United States 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 Yale University,Substudy-02 New Haven Connecticut
United States Yale University; School of Medicine; AIDS Program (Administrative & Study Supplies),Substudy-03 New Haven Connecticut
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 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 MultiCare Rockwood Main Clinic- Research,Substudy-03 Spokane Washington
United States Washington Health Institute,Substudy-01 Washington District of Columbia
United States Washington Health Institute,Substudy-02 Washington District of Columbia
United States Washington Health Institute,Substudy-03 Washington District of Columbia
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

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Dominican Republic,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary All Substudies: Change From Baseline in Plasma Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (log10 copies/mL) at Day 11 Baseline; Day 11
Secondary All Substudies: Change From Baseline in Plasma HIV-1 RNA (log10 copies/mL) at Day 8 Baseline; Day 8
Secondary All Substudies: Percentage of Participants Experiencing Adverse Events (AEs) Substudy-01: First dose date up to Day 39; Substudy-02: First dose date up to Day 60; Substudy-03 First dose date up to Day 25
Secondary All Substudies: Percentage of Participants Experiencing Graded Laboratory Abnormalities Substudy-01: First dose date up to Day 39; Substudy-02: First dose date and up to Day 60; Substudy-03 First dose date up to Day 25
Secondary Substudy-01, Substudy-02, and Substudy-03: Pharmacokinetic (PK) Parameter: Cmax of bavtavirine, GS-1720, and GS-6212 Cmax is defined as the maximum observed concentration of drug. Day 1 Predose up to Day 11
Secondary Substudy-01, Substudy-02, and Substudy-03: PK Parameter of: AUC of bavtavirine, GS-1720, and GS-6212 AUC is defined as the area under the concentration versus time curve. Substudy-01: Day 1 Predose up to Day 39; Substudy-02: Day 1 Predose up to Day 60
Secondary Substudy-01, Substudy-02, and Substudy-03: PK Parameter: Ct of bavtavirine, GS-1720, and GS-6212 Ct is defined as the concentration at specified time "t". Day 1 Predose up to Day 11
Secondary All Substudies: Correlation Between Ct and/or AUC versus the Reduction of Plasma HIV-1 RNA (Log10 Copies/mL) from Day 1 Through Day 11 Day 1 up to Day 11
Secondary All Substudies: Percentage of Participants at Any Measurement Achieving HIV-1 RNA < 50 Copies/mL by Day 11 at Each Dose Level Up to Day 11
Secondary Percentage of Participants with Emergence of Viral Resistance to the ARV Class of the Given Drug The ARV class of given drugs would be BVY or NNRTIs (Substudy 01) or INSTIs (Substudy 02) or INSTIs (Substudy 03). Up to Day 11
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