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

Pilot Study of a Raltegravir Based NRTI Sparing Regimen

Not Applicable

Completed

Conditions: HIV Infections
AIDS
Human Immunodeficiency Virus
Acquired Immune Deficiency Syndrome

Interventions: Other: Standard treatment regimen
Drug: Raltegravir
Drug: Atazanavir

First Posted Date: 2008-12-25

Last Posted Date: 2016-02-04

Lead Sponsor: Yale University

Target Recruit Count: 60

Registration Number: NCT00814879

Locations: 🇺🇸
Saint Raphael Healthcare System, New Haven, Connecticut, United States
🇺🇸
Waterbury Hospital, Waterbury, Connecticut, United States
🇺🇸
VA CT Healthcare Systems, West Haven, Connecticut, United States

and more 2 locations

Comparative Study of Three NNRTI-Sparing HAART Regimens

Phase 3

Completed

Conditions: HIV Infection

Interventions: Drug: Emtricitabine/tenofovir disoproxil fumarate
Drug: Ritonavir
Drug: Raltegravir
Drug: Darunavir
Drug: Atazanavir

First Posted Date: 2008-12-19

Last Posted Date: 2014-09-05

Lead Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Target Recruit Count: 1814

Registration Number: NCT00811954

Locations: 🇺🇸
The Ponce de Leon Center CRS, Atlanta, Georgia, United States
🇺🇸
The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States
🇺🇸
Trinity Health and Wellness Center, Dallas, Texas, United States

and more 54 locations

Phase IIB Pilot of Atazanavir + Raltegravir

Phase 2

Terminated

Conditions: HIV

Interventions: Drug: Atazanavir
Drug: Raltegravir
Drug: Ritonavir
Drug: Tenofovir/Emtricitabine

First Posted Date: 2008-10-08

Last Posted Date: 2012-02-24

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 167

Registration Number: NCT00768989

Locations: 🇺🇸
Orlando Immunology Center, Orlando, Florida, United States
🇫🇷
Local Institution, Paris Cedex 20, France
🇺🇸
Yale University School Of Medicine, New Haven, Connecticut, United States

and more 7 locations

Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

Phase 4

Completed

Conditions: HIV

Interventions: Drug: ritonavir
Drug: darunavir
Drug: atazanavir
Drug: emtricitabine [FTC]/tenofovir [TDF]

First Posted Date: 2008-09-23

Last Posted Date: 2015-12-30

Lead Sponsor: Tibotec, Inc

Target Recruit Count: 68

Registration Number: NCT00757783

Effect of the HIV Protease Inhibitors Atazanavir and Lopinavir/Ritonavir on Cardiovascular Disease Risk Factors

Not Applicable

Completed

Conditions: Endothelial Dysfunction

Interventions: Drug: Atazanavir
Drug: Lopinavir/ritonavir
Drug: Placebo

First Posted Date: 2008-07-23

Last Posted Date: 2017-10-25

Lead Sponsor: Indiana University

Target Recruit Count: 30

Registration Number: NCT00720590

Locations: 🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus Related Endothelial Dysfunction

Interventions: Drug: placebo + atazanavir
Drug: atazanavir + placebo

First Posted Date: 2008-06-13

Last Posted Date: 2010-01-26

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 16

Registration Number: NCT00696722

Locations: 🇳🇱
Radboud University Nijmegen Medical Centre, Nijmegen, Gelderland, Netherlands

Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: tenofovir DF 300 mg QD
Drug: emtricitabine 200 mg QD
Drug: Nevirapine 200 mg BID
Drug: Atazanavir 300 mg
Drug: Ritonavir 100 mg

First Posted Date: 2007-11-01

Last Posted Date: 2014-01-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 154

Registration Number: NCT00552240

Locations: 🇺🇸
1100.1512.24 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
🇺🇸
1100.1512.20 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States
🇺🇸
1100.1512.17 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States

and more 16 locations