Bictegravir

Generic Name: Bictegravir

Brand Names: Biktarvy

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₁₈F_₃N_₃O_₅

CAS Number: 1611493-60-7

Unique Ingredient Identifier: 8GB79LOJ07

Background: Bictegravir is a recently approved investigational drug that has been used in trials studying the treatment of HIV-1 and HIV-2 infection. It has been approved for HIV-1 monotherapy combined with 2 other antiretrovirals in a single tablet.

Indication: Bictegravir is indicated in the management of HIV-1 infection in patients not previously treated with antiretroviral therapy. Additionally, Bictegravir is indicated in the management of HIV-1 infection in patients who are virologically suppressed (HIV-1 RNA <50 c/mL) on a regular antiretroviral regimen for a minimum of three months without a history of failu...

Associated Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Associated Therapies: -

Clinical Trials

Incidence of Metabolic Syndrome in People Living With HIV Without ExperienCe to ART Who Start DoLutegravir Based-Regimen Compared With BictegrAvir Based-RegimeN

Not Applicable

Completed

Conditions: Antiretroviral Treatment
HIV Infection
Metabolic Cardiovascular Syndrome

Interventions: Drug: Bictegravir

First Posted Date: 2024-10-07

Last Posted Date: 2024-10-07

Lead Sponsor: Instituto Mexicano del Seguro Social

Target Recruit Count: 378

Registration Number: NCT06629480

Locations: 🇲🇽
Hospital de Infectología, "La Raza" National Medical Center, Mexico City, Mexico

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

Phase 3

Recruiting

Conditions: HIV-1-infection

Interventions: Drug: Bictegravir
Drug: Lenacapavir
Drug: B/F/TAF
Drug: Placebo to match B/F/TAF
Drug: Placebo to match BIC/LEN

First Posted Date: 2024-03-27

Last Posted Date: 2024-11-12

Lead Sponsor: Gilead Sciences

Target Recruit Count: 546

Registration Number: NCT06333808

Locations: 🇦🇷
Fundacion Huesped, Buenos Aires, Argentina
🇨🇦
Regina General Hospital, Regina, Canada
🇩🇪
Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany

and more 99 locations

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 Therapy

Phase 3

Recruiting

Conditions: HIV
HIV Infections

Interventions: Drug: Dolutegravir
Drug: Bictegravir
Drug: Lamivudine
Drug: Emtricitabine
Drug: Tenofovir alafenamide

First Posted Date: 2023-08-07

Last Posted Date: 2024-08-19

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 412

Registration Number: NCT05979311

Locations: 🇬🇧
GSK Investigational Site, London, United Kingdom

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

Phase 2

Active, not recruiting

Conditions: HIV-1-infection

Interventions: Drug: Stable Baseline Regimen
Drug: BIC/LEN FDC
Drug: Bictegravir
Drug: Lenacapavir

First Posted Date: 2022-08-16

Last Posted Date: 2024-11-26

Lead Sponsor: Gilead Sciences

Target Recruit Count: 689

Registration Number: NCT05502341

Locations: 🇰🇷
Chungnam National University Hospital, Daejeon, Korea, Republic of
🇰🇷
Yonsei University Severance Hospital, Seoul, Korea, Republic of
🇰🇷
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea, Republic of

and more 90 locations

Gut Microbiota, PGx and INSTIs Response

Completed

Conditions: HIV Infections

Interventions: Drug: Bictegravir
Drug: Dolutegravir

First Posted Date: 2021-03-18

Last Posted Date: 2024-05-10

Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Target Recruit Count: 180

Registration Number: NCT04805944

Locations: 🇧🇪
Cliniques universitaires Saint-Luc, Brussels, Belgium

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

Phase 4

Completed

Conditions: HIV Prevention

Interventions: Drug: bictegravir

First Posted Date: 2018-04-17

Last Posted Date: 2022-04-07

Lead Sponsor: Fenway Community Health

Target Recruit Count: 52

Registration Number: NCT03499483

Locations: 🇺🇸
Fenway Community Health, Boston, Massachusetts, United States

Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Bictegravir

First Posted Date: 2015-03-27

Last Posted Date: 2019-10-11

Lead Sponsor: Gilead Sciences

Target Recruit Count: 19

Registration Number: NCT02400307

Locations: 🇺🇸
Avail Clinical Research, DeLand, Florida, United States
🇺🇸
Clinical Pharmacology of Miami, Inc., Miami, Florida, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

and more 4 locations

Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants

Phase 1

Completed

Conditions: HIV-1 Infection

Interventions: Drug: Placebo
Drug: Bictegravir

First Posted Date: 2014-10-27

Last Posted Date: 2020-11-09

Lead Sponsor: Gilead Sciences

Target Recruit Count: 23

Registration Number: NCT02275065

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