Drug
Bictegravir clinical trials
Also written GS-9883.
- studies test it
- 44
- open now
- 4
- in phase 3
- 15
- first study started
- 2014
Keep track of what changes. Save the bictegravir studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
44 studies that test it; most in 2019 (7)
| Year | Studies |
|---|---|
| 2014 | 1 |
| 2015 | 6 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 7 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 4 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 6
- Phase 2
- 8
- Phase 3
- 15
- Phase 4
- 17
- No phase
- 1
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 24 · Other 20
Gilead Sciences (22) · Shanghai Public Health Clinical Center (1) · Merck Sharp & Dohme LLC (1) · Peking Union Medical College Hospital (1) · Instituto Mexicano del Seguro Social (1) · Midland Research Group, Inc. (1) · Carmen Hidalgo Tenorio (1) · University of Maryland, Baltimore (1)
Often tested with
Tested in the same studies.
Emtricitabine (37) · Tenofovir alafenamide (37) · Lenacapavir (6) · Elvitegravir (2) · Cobicistat (2) · GS-3242 (2) · Islatravir (1) · Dolutegravir (1)
Studies
Open first, then newest update. How each study uses bictegravir is read from its arms, and is right about nine times in ten.
Testing it · 44
- A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1RecruitingPhase 2Gilead SciencesNCT07645287Written as B/F/TAF
- Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 TreatmentRecruitingPhase 2/3Gilead SciencesNCT07708727Written as B/F/TAF
- REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidERecruitingPhase 4CAN Community HealthNCT07476339Written as Bictegravir, emtricitabine, and tenofovir alafenamide
- The Antiretroviral Speed Access Program Switch (ASAP-Switch) StudyNot yet recruitingPhase 4McGill University Health Centre/Research Institute of the McGill University Health CentreNCT06375304Written as B/F/TAF
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (ARTISTRY-1)Active, not recruitingPhase 2/3Gilead SciencesNCT05502341Written as Bictegravir
- Study of Bictegravir/Lenacapavir in Children and Adolescents With HIV-1Active, not recruitingPhase 2/3Gilead SciencesNCT06532656Written as Bictegravir/Lenacapavir (BIC/LEN) FDC
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIVActive, not recruitingPhase 1Gilead SciencesNCT07055451Written as B/F/TAF
- A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)CompletedPhase 1Merck Sharp & Dohme LLCNCT07532304Written as Bictegravir/emtricitabine/tenofovir alafenamide
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With BiktarvyActive, not recruitingPhase 3Gilead SciencesNCT06333808Written as Bictegravir
- Biktarvy in Treatment-Naïve Late Presenters With HIV-1 InfectionCompletedPhase 4Peking Union Medical College HospitalNCT04296695Written as B/F/TAF
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1Active, not recruitingPhase 3Gilead SciencesNCT06630286Written as B/F/TAF
- Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)CompletedPhase 4Gilead SciencesNCT06104306Written as B/F/TAF
- Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIVActive, not recruitingPhase 2Gilead SciencesNCT05052996Written as B/F/TAF
- Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected AdultsCompletedPhase 3Gilead SciencesNCT03547908Written as B/F/TAF
- Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeNCompletedNot applicableInstituto Mexicano del Seguro SocialNCT06629480Written as Bictegravir
- Study to Evaluate the Safety and Efficacy of Lenacapavir (GS-6207) in Combination With Other Antiretroviral Agents in People Living With HIVCompletedPhase 2Gilead SciencesNCT04143594Written as BIC
- Efficacy, Safety & Tolerability of Switching EFV/TDF/FTC to BIC/FTC/TAF in Virologically Suppressed Adults With HIV-1CompletedPhase 4Midland Research Group, Inc.NCT03502005Written as bictegravir/emtricitabine/tenofovir alafenamide
- Study to Evaluate the Pharmacokinetics (PK), Safety, and Efficacy of B/F/TAF in Human Immunodeficiency Virus (HIV)-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third TrimestersCompletedPhase 1Gilead SciencesNCT03960645Written as B/F/TAF
- Switching From TDF-based Antiretroviral Therapy Regimens to B/F/TAF in Virally Suppressed Adults With HIV-1 InfectionActive, not recruitingPhase 4Shanghai Public Health Clinical CenterNCT05122754Written as B/F/TAF
- Study of Bictegravir/Emtricitavine/Tenofovir Alafenamide in HIV-1 Infected naïve Patients Using Test and Treat Stategy Rapid-initiation Model of Care: BIC-NOW Clinical Trial (BIC-NOW)CompletedPhase 4Carmen Hidalgo TenorioNCT06177574Written as BIC/FTC/TAF
See all 44 studies that test bictegravir →
Given in every arm · 5 — bictegravir is usual care beside what is tested
- Study of Novel Antiretrovirals in Participants With HIV-1CompletedPhase 1Gilead SciencesNCT05585307Written as B/F/TAF
- 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 ParticipantsCompletedPhase 3Gilead SciencesNCT03631732Written as B/F/TAF
- Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Lenacapavir Administered Subcutaneously in Human Immunodeficiency Virus (HIV) -1 Infected AdultsCompletedPhase 1Gilead SciencesNCT03739866Written as B/F/TAF
- Study to Evaluate the Efficacy of GS-9131 Functional Monotherapy in Human Immunodeficiency Virus (HIV)-1-Infected Adults Failing a Nucleos(t)Ide Reverse Transcriptase Inhibitor-Containing Regimen With Nucleos(t)Ide Reverse Transcriptase Inhibitor Resistant VirusTerminatedPhase 2Gilead SciencesNCT03472326Written as BIC
- Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected AdultsCompletedPhase 3Gilead SciencesNCT02603107Written as B/F/TAF
As the comparator · 13 — what is tested is compared with bictegravir
- Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus LevelsRecruitingPhase 2Gilead SciencesNCT07841990Written as B/F/TAF
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)RecruitingPhase 2/3Merck Sharp & Dohme LLCNCT07266831Written as BIC/FTC/TAF
- DOR/TDF/3TC COmpared With BIC/FTC/TAF in ART-Naïve People Living With HIV and Overweight or ObesityRecruitingPhase 3José Antonio Mata MarínNCT07075146Written as BIC/FTC/TAF
- Safety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral ExperienceRecruitingPhase 4Instituto Mexicano del Seguro SocialNCT07031063Written as Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral TherapyActive, not recruitingPhase 3ViiV HealthcareNCT05979311Written as Bictegravir
- DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)Active, not recruitingPhase 3Merck Sharp & Dohme LLCNCT05705349Written as BIC/FTC/TAF
- Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020)CompletedPhase 3Merck Sharp & Dohme LLCNCT04233879Written as BIC/FTC/TAF
- Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically SuppressedActive, not recruitingPhase 2/3Gilead SciencesNCT06544733Written as Bictegravir/emtricitabine/tenofovir alafenamide
- Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been TreatedTerminatedPhase 2/3Gilead SciencesNCT06613685Written as Bictegravir/emtricitabine/tenofovir alafenamide
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)CompletedPhase 3Merck Sharp & Dohme LLCNCT04223791Written as BIC/FTC/TAF
- Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013]CompletedPhase 2Merck Sharp & Dohme LLCNCT04564547Written as BIC/FTC/TAF
- A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052)Active, not recruitingPhase 3Merck Sharp & Dohme LLCNCT05630755Written as BIC/FTC/TAF
- A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)Active, not recruitingPhase 2Merck Sharp & Dohme LLCNCT06891066Written as BIC/FTC/TAF
Codes
What other systems call bictegravir · ClinicalTrials.gg INT000714
- MeSH (NLM) C000620396bictegravirOne source NLM
- UNII (FDA) 8GB79LOJ07BICTEGRAVIRConfirmed FDA, NLM, Wikidata
- RxNorm 1999660Confirmed FDA, Wikidata
- Wikidata Q27270406bictegravirConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C171719BictegravirOne source FDA
- DrugBank DB11799One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000620396 | bictegravir | One source NLM |
| UNII (FDA) | 8GB79LOJ07 | BICTEGRAVIR | Confirmed FDA, NLM, Wikidata |
| RxNorm | 1999660 | — | Confirmed FDA, Wikidata |
| Wikidata | Q27270406 | bictegravir | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C171719 | Bictegravir | One source FDA |
| DrugBank | DB11799 | — | One source Wikidata |
Also registered as bictegravir sodium (UNII 4L5MP1Y7W7 · RxNorm 1999661).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.