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ClinicalTrials.gov public records Last synced Oct 18, 2026, 11:20 PM EDT

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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Biktarvy Clear all
Not listed No phase listed Observational

Bictegravir in the Elderly Living With HIV (BICEP)

NCT05064020
View directory record Official record
Conditions
HIV-1-infection
Interventions
Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]
Drug
Lead sponsor
State University of New York at Buffalo
Other
Eligibility
18 Years and older
Enrollment
162 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Jun 4, 2024 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 1 Interventional

Study of GS-3242 in Participants With HIV-1; Substudy-05

NCT07001319
View directory record Official record
Conditions
HIV-1-infection
Interventions
GS-3242, BVY, Standard of Care
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years to 65 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
21
States / cities
Bakersfield, California • Los Angeles, California • San Francisco, California + 15 more
Source: ClinicalTrials.gov public record
Updated May 11, 2026 · Synced Oct 18, 2026, 11:20 PM EDT
Recruiting Phase 2 Interventional

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

NCT05719441
View directory record Official record
Conditions
Acute HIV Infection
Interventions
VRC07-523LS, PGT121.414.LS, Placebo, ART
Biological · Other · Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 70 Years
Enrollment
48 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
9
States / cities
Birmingham, Alabama • Aurora, Colorado • Atlanta, Georgia + 6 more
Source: ClinicalTrials.gov public record
Updated Oct 14, 2026 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

NCT03631732
View directory record Official record
Conditions
HIV-1 Infection
Interventions
B/F/TAF, NRTIs, Third Agent
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
496 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
82
States / cities
Birmingham, Alabama • Mobile, Alabama • Los Angeles, California + 53 more
Source: ClinicalTrials.gov public record
Updated Sep 5, 2021 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 3 Interventional

Next Generation Ingestible Sensors for Medication Adherence Measurement

NCT05592613
View directory record Official record
Conditions
HIV Infection, Adherence, Medication, Adherence, Treatment, Pre-Exposure Prophylaxis, Antiretroviral Therapy
Interventions
Next-generation Reader and ID-Cap System, Truvada for pre-exposure prophylaxis (PrEP), Biktarvy for antiretroviral therapy (ART)
Device · Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years and older
Enrollment
15 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Sep 25, 2024 · Synced Oct 18, 2026, 11:20 PM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1

NCT06630299
View directory record Official record
Conditions
HIV-1-Infection
Interventions
ISL/LEN, Antiretroviral Combinations
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2030
U.S. locations
49
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 41 more
Source: ClinicalTrials.gov public record
Updated May 29, 2026 · Synced Oct 18, 2026, 11:20 PM EDT
Recruiting Phase 2 Interventional

A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1

NCT07645287
View directory record Official record
Conditions
HIV-1-infection
Interventions
GS-3242 Tablet, GS-3242 Injection, Lenacapavir Tablet, Lenacapavir Injection, B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
175 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
47
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 42 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2026 · Synced Oct 18, 2026, 11:20 PM EDT
Not listed Phase 4 Interventional

Empiric Treatment for Acute HIV in the ED

NCT03711253
View directory record Official record
Conditions
Acute HIV Infection
Interventions
Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg
Drug
Lead sponsor
University of Southern California
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
2
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Apr 26, 2023 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 4 Interventional Results available

Bictegravir/Emtricitabine/Tenofovir Alafenide Plus Doravirine

NCT04538040
View directory record Official record
Conditions
HIV-1-infection
Interventions
Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch
Drug
Lead sponsor
Quest Clinical Research
Other
Eligibility
45 Years and older · Male only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
San Francisco, California
Source: ClinicalTrials.gov public record
Updated Mar 5, 2024 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 4 Interventional Results available

Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM

NCT04039217
View directory record Official record
Conditions
ART, HIV
Interventions
Biktarvy
Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years to 49 Years · Male only
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Feb 22, 2022 · Synced Oct 18, 2026, 11:20 PM EDT
Not listed Phase 4 Interventional

Effect of Biktarvy & Symtuza on microRNAs in HIV and Correlation With Weight Gain

NCT05463783
View directory record Official record
Conditions
HIV Infections, Obesity
Interventions
Biktarvy, Symtuza
Drug
Lead sponsor
East Carolina University
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Greenville, North Carolina
Source: ClinicalTrials.gov public record
Updated Nov 14, 2023 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607930
View directory record Official record
Conditions
HIV-1 Infection
Interventions
ABC/DTG/3TC, B/F/TAF, ABC/DTG/3TC Placebo, B/F/TAF Placebo
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
631 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
78
States / cities
Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 57 more
Source: ClinicalTrials.gov public record
Updated Mar 2, 2022 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 4 Interventional Results available

Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

NCT04650269
View directory record Official record
Conditions
Harm Reduction, HIV Infections, Drug Use
Interventions
Biktarvy 50Mg-200Mg-25Mg Tablet, HIV care
Drug · Other
Lead sponsor
University of Miami
Other
Eligibility
18 Years and older
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jan 8, 2025 · Synced Oct 18, 2026, 11:20 PM EDT
Terminated Phase 4 Interventional

Rapid Start vs. Standard Start Antiretroviral Therapy (ART) in HIV

NCT04249037
View directory record Official record
Conditions
HIV/AIDS
Interventions
bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), Standard initiation of antiretroviral therapy (ART)
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
15 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
3
States / cities
Aurora, Colorado • Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Nov 30, 2023 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 2 Interventional Results available

Early ART to Limit Infection and Establishment of Reservoir

NCT02859558
View directory record Official record
Conditions
HIV-1 Infection
Interventions
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Drug
Lead sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Network
Eligibility
18 Years and older
Enrollment
195 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2025
U.S. locations
23
States / cities
Birmingham, Alabama • San Diego, California • Torrance, California + 17 more
Source: ClinicalTrials.gov public record
Updated Aug 29, 2025 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIV

NCT04143594
View directory record Official record
Conditions
HIV-1-infection
Interventions
Oral Lenacapavir, F/TAF, Subcutaneous Lenacapavir, TAF, BIC, B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
183 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2023
U.S. locations
49
States / cities
Phoenix, Arizona • Los Angeles, California • Palm Springs, California + 40 more
Source: ClinicalTrials.gov public record
Updated Oct 2, 2024 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 3 Interventional Results available

Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

NCT02607956
View directory record Official record
Conditions
HIV-1 Infection
Interventions
DTG, F/TAF, B/F/TAF, DTG Placebo, F/TAF Placebo, B/F/TAF Placebo
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
657 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2021
U.S. locations
74
States / cities
Phoenix, Arizona • Beverly Hills, California • Los Angeles, California + 53 more
Source: ClinicalTrials.gov public record
Updated Mar 7, 2022 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 3 Interventional Results available

Effects of Biktarvy on CFR in Stable HIV Patients

NCT03656783
View directory record Official record
Conditions
HIV
Interventions
Biktarvy
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years to 95 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
3
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Feb 8, 2023 · Synced Oct 18, 2026, 11:20 PM EDT
Not listed Phase 4 Interventional

Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)

NCT04826562
View directory record Official record
Conditions
Human Immunodeficiency Virus
Interventions
Dolutegravir/Lamivudine
Drug
Lead sponsor
Saint Michael's Medical Center
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Newark, New Jersey
Source: ClinicalTrials.gov public record
Updated Oct 11, 2023 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

NCT02652624
View directory record Official record
Conditions
HIV-1 Infection
Interventions
E/C/F/TAF, E/C/F/TDF, ATV, RTV, FTC/TDF, B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older · Female only
Enrollment
472 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
29
States / cities
Stamford, Connecticut • Washington D.C., District of Columbia • Fort Lauderdale, Florida + 22 more
Source: ClinicalTrials.gov public record
Updated Mar 4, 2020 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Biktarvy for Non-Occupational Post-Exposure Prophylaxis (nPEP)

NCT03499483
View directory record Official record
Conditions
HIV Prevention
Interventions
bictegravir
Drug
Lead sponsor
Fenway Community Health
Other
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019 – 2020
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Apr 7, 2022 · Synced Oct 18, 2026, 11:20 PM EDT
Active, not recruiting Phase 3 Interventional

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy

NCT06333808
View directory record Official record
Conditions
HIV-1-infection
Interventions
Bictegravir, Lenacapavir, B/F/TAF, Placebo to match B/F/TAF, Placebo to match BIC/LEN
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
577 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
51
States / cities
Phoenix, Arizona • Berkeley, California • Beverly Hills, California + 43 more
Source: ClinicalTrials.gov public record
Updated Jun 15, 2026 · Synced Oct 18, 2026, 11:20 PM EDT
Terminated Phase 2Phase 3 Interventional

Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated

NCT06613685
View directory record Official record
Conditions
HIV-1-infection
Interventions
lepetegravir, lenacapavir pacfosacil, Bictegravir/emtricitabine/tenofovir alafenamide, lepetegravir/lenacapavir pacfosacil FDC, Placebo to Match BVY, Placebo to Match GS1720/GS-4182 FDC
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2026
U.S. locations
21
States / cities
Birmingham, Alabama • Torrance, California • West Hollywood, California + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 15, 2026 · Synced Oct 18, 2026, 11:20 PM EDT
Completed Phase 4 Interventional Results available

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

NCT06104306
View directory record Official record
Conditions
HIV-1-infection
Interventions
B/F/TAF
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
33 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
10
States / cities
Bakersfield, California • Palm Springs, California • San Diego, California + 7 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2026 · Synced Oct 18, 2026, 11:20 PM EDT