Atazanavir

Generic Name: Atazanavir

Brand Names: Evotaz, Reyataz, Atazanavir Krka, Atazanavir Viatris (previously Atazanavir Mylan)

Drug Type: Small Molecule

Chemical Formula: C_₃₈H_₅₂N_₆O_₇

CAS Number: 198904-31-3

Unique Ingredient Identifier: QZU4H47A3S

Background: Atazanavir (formerly known as BMS-232632) is an antiretroviral drug of the protease inhibitor (PI) class. Like other antiretrovirals, it is used to treat infection of human immunodeficiency virus (HIV). Atazanavir is distinguished from other PIs in that it can be given once daily (rather than requiring multiple doses per day) and has lesser effects on the patient's lipid profile (the amounts of cholesterol and other fatty substances in the blood). Like other protease inhibitors, it is used only in combination with other HIV medications. The U.S. Food and Drug Administration (FDA) approved atazanavir on June 20, 2003.

Indication: Atazanavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 3 months of age and older weighing at least 5kg. Atazanavir is also indicated in combination with cobicistat and other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35kg.

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

Clinical Trials

A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: atazanavir
Drug: danoprevir
Drug: ritonavir
Drug: tenofovir disoproxil fumarate

First Posted Date: 2012-05-07

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 40

Registration Number: NCT01592305

A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: RO5093151
Drug: ketoconazole
Drug: rifampicin
Drug: atazanavir
Drug: ritonavir

First Posted Date: 2012-05-04

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 51

Registration Number: NCT01591850

Pharmacokinetics, Safety & Tolerability of Isotopologs of Atazanavir (ATV), With Pharmacokinetic Comparison to Reyataz

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: C-10276
Drug: C-10297
Drug: C-10299
Drug: Reyataz®

First Posted Date: 2011-10-25

Last Posted Date: 2013-05-24

Lead Sponsor: Concert Pharmaceuticals

Target Recruit Count: 47

Registration Number: NCT01458769

A Study on Antiretroviral Therapy (ART) Naïve Patients On Different Regimens to Treat Hiv (NORTHIV)

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Atazanavir ritonavir
Drug: Lopinavir ritonavir
Drug: Efavirenz

First Posted Date: 2011-10-03

Last Posted Date: 2011-10-04

Lead Sponsor: Göteborg University

Target Recruit Count: 242

Registration Number: NCT01445223

Locations: 🇸🇪
Department of Infectious Diseases, Goteborg, Sweden

A Pilot Study of Moderate Hyperbilirubinemia in Type 1 Diabetes Mellitus

Phase 1

Completed

Conditions: Type 1 Diabetes Mellitus

Interventions: Drug: Atazanavir

First Posted Date: 2011-08-22

Last Posted Date: 2014-07-21

Lead Sponsor: Brigham and Women's Hospital

Target Recruit Count: 15

Registration Number: NCT01421355

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects

Phase 1

Completed

Conditions: HIV

Interventions: Drug: Atazanavir (POU2)
Drug: Atazanavir (current formulation)
Drug: Atazanavir, powder for oral use 1 (POU1)

First Posted Date: 2011-07-28

Last Posted Date: 2013-06-10

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 12

Registration Number: NCT01404572

Locations: 🇺🇸
Pra International, Lenexa, Kansas, United States

Genetics and HIV-1 Protease Inhibitors

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Atazanavir

First Posted Date: 2011-07-06

Last Posted Date: 2019-11-19

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 31

Registration Number: NCT01388543

Locations: 🇺🇸
University of Colorado Denver and Health Sciences Center, Aurora, Colorado, United States

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Phase 2

Completed

Conditions: Infection, Human Immunodeficiency Virus

Interventions: Drug: BMS-663068 400 mg
Drug: BMS-663068 1200 mg
Drug: BMS-663068 600 mg
Drug: BMS-663068 800 mg
Drug: Raltegravir 400 mg
Drug: Tenofovir 300 mg
Drug: Ritonavir 100 mg
Drug: Atazanavir 300 mg

First Posted Date: 2011-06-29

Last Posted Date: 2018-11-14

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 254

Registration Number: NCT01384734

Locations: 🇪🇸
GSK Investigational Site, Madrid, Spain

Two Clinical Trials to Evaluate Pharmacokinetics of Unboosted and Boosted Atazanavir Used Alone or Co-administered With Tenofovir DF in Healthy Korean and Caucasian Male Volunteers

Phase 1

Conditions: Atazanavir

Interventions: Drug: Atazanavir(ATZ) and Tenofovir(TDF)
Drug: Atazanavir(ATZ) + Ritonavir
Drug: atazanavir(ATZ) + tenofovir(TDF) + ritonavir
Drug: atazanavir