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

Associated Therapies: -

Clinical Trials

DDI HV (ATV - Merck)

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Atazanavir + Raltegravir
Drug: Raltegravir
Drug: Atazanavir

First Posted Date: 2007-08-20

Last Posted Date: 2010-02-04

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 22

Registration Number: NCT00518297

Locations: 🇺🇸
Bristol-Myers Squibb Clinical Pharmacology Unit, Hamilton, New Jersey, United States

Effect of Atazanavir on Endothelial Function in HIV-Infected Patients

Phase 4

Completed

Conditions: HIV Infections
Dyslipidemia

First Posted Date: 2007-03-14

Last Posted Date: 2009-05-27

Lead Sponsor: Foundation for Cardiovascular Research, Zurich

Target Recruit Count: 50

Registration Number: NCT00447070

Locations: 🇨🇭
University Hospital Zurich, Infectiology, Zurich, ZH, Switzerland

Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

Phase 4

Terminated

Conditions: HIV Infection

Interventions: Drug: lopinavir/ritonavir
Drug: atazanavir

First Posted Date: 2007-01-11

Last Posted Date: 2009-02-06

Lead Sponsor: University of Oklahoma

Target Recruit Count: 19

Registration Number: NCT00420355

Locations: 🇺🇸
OUHSC General Clinical Research Center, Oklahoma City, Oklahoma, United States

Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Atazanavir

First Posted Date: 2006-12-15

Last Posted Date: 2020-07-17

Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Target Recruit Count: 22

Registration Number: NCT00411957

Locations: 🇹🇭
HIV-NAT, Thai Red Cross AIDS Research Center, Bangkok, Thailand

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: nevirapine bid
Drug: nevirapine qd
Drug: atazanavir

First Posted Date: 2006-10-18

Last Posted Date: 2014-01-27

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 576

Registration Number: NCT00389207

Locations: 🇲🇽
1100.1470.55001 Boehringer Ingelheim Investigational Site, Col. Toriello Guerra, Mexico
🇵🇹
1100.1470.35103 Boehringer Ingelheim Investigational Site, Porto, Portugal
🇨🇭
1100.1470.41002 Boehringer Ingelheim Investigational Site, Zürich, Switzerland

and more 65 locations

Drug Interaction Study With Proton Pump Inhibitor

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Atazanavir/Ritonavir
Drug: Atazanavir/Ritonavir+Omeprazole
Drug: Atazanavir

First Posted Date: 2006-07-27

Last Posted Date: 2011-04-08

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 56

Registration Number: NCT00357240

Locations: 🇺🇸
Local Institution, Hamilton, New Jersey, United States

A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

Phase 4

Terminated

Conditions: HIV Infections

First Posted Date: 2006-04-11

Last Posted Date: 2016-09-19

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 70

Registration Number: NCT00312754

Locations: 🇫🇷
Local Institution, Paris, France

Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Nelfinavir
Drug: Saquinavir/ritonavir
Drug: Lopinavir/ritonavir
Drug: Atazanavir
Drug: Atazanavir/ritonavir
Drug: Fos-amprenavir/ritonavir
Drug: Tipranavir/ ritonavir
Drug: Darunavir/ritonavir
Drug: Nevirapine
Drug: Efavirenz
Drug: Indinavir/ritonavir

First Posted Date: 2006-03-28

Last Posted Date: 2019-12-04

Lead Sponsor: Germans Trias i Pujol Hospital

Target Recruit Count: 675

Registration Number: NCT00307502

Locations: 🇪🇸
Hospital de Figueres, Figueras, Barcelona, Spain
🇪🇸
Hospital Universitari Sant Joan de Reus, Reus, Tarragona, Spain
🇪🇸
Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain

and more 3 locations

Blood Levels of Anti-HIV Drugs Used in Combination Regimens in HIV Infected Children

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Efavirenz
Drug: Darunavir
Drug: Atazanavir
Drug: Nevirapine
Drug: Ritonavir
Procedure: Pharmacokinetic Study
Drug: Tenofovir disoproxil fumarate

First Posted Date: 2005-12-01

Last Posted Date: 2021-11-09

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 75

Registration Number: NCT00260078

Locations: 🇺🇸
Rush Univ. Cook County Hosp. Chicago NICHD CRS, Chicago, Illinois, United States
🇺🇸
Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS, Chicago, Illinois, United States
🇺🇸
Children's Hosp. of Boston NICHD CRS, Boston, Massachusetts, United States

and more 20 locations

Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

Phase 3

Completed

Conditions: HIV Infection
Hyperlipidemia

Interventions: Drug: current antiretroviral regimen
Drug: Atazanavir

First Posted Date: 2005-09-23

Last Posted Date: 2012-08-02

Lead Sponsor: Northwestern University

Target Recruit Count: 50

Registration Number: NCT00225017

Locations: 🇮🇹
Universita degli studi di Modena e Reggio Emilia, Modena, Italy
🇦🇷
ACLIRES - Argentina S.R.L., Buenos Aires, Argentina
🇺🇸
University of California, San Diego, California, United States

and more 4 locations

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