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

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

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

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

First Posted Date: 2011-06-08

Last Posted Date: 2011-06-08

Lead Sponsor: Asan Medical Center

Target Recruit Count: 32

Registration Number: NCT01368783

Locations: 🇰🇷
Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of

Switch to Unboosted Atazanavir With Tenofovir Study

Phase 4

Completed

Conditions: HIV Infection

Interventions: Drug: atazanavir/ritonavir
Drug: atazanavir

First Posted Date: 2011-05-11

Last Posted Date: 2018-07-30

Lead Sponsor: University of British Columbia

Target Recruit Count: 50

Registration Number: NCT01351740

Locations: 🇨🇦
Immunodeficiency Clinic, St. Paul's Hospital, Vancouver, British Columbia, Canada

Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

Phase 4

Completed

Conditions: HIV, Combination Therapy

Interventions: Drug: Atazanavir
Drug: Ritonavir (heat-stable)
Drug: Tenofovir/Emtricitabine
Drug: Raltegravir

First Posted Date: 2011-04-11

Last Posted Date: 2015-02-19

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 132

Registration Number: NCT01332227

Locations: 🇺🇸
Health For Life Clinic Pllc, Little Rock, Arkansas, United States
🇺🇸
Eisenhower Medical Center, Palm Springs, California, United States
🇺🇸
Consultive Medicine, Daytona Beach, Florida, United States

and more 6 locations

A Multicentre Trial of Second-line Antiretroviral Treatment Strategies in African Adults Using Atazanavir or Lopinavir/Ritonavir

Phase 3

Withdrawn

Conditions: HIV

Interventions: Drug: Lopinavir
Drug: Atazanavir

First Posted Date: 2010-12-07

Last Posted Date: 2012-11-08

Lead Sponsor: ANRS, Emerging Infectious Diseases

Registration Number: NCT01255371

Locations: 🇹🇿
NIMR-Mbeya Medical Research Program-Mbeya Referral Hospital, Mbeya, Tanzania
🇿🇦
Tshepang clinic, Limpopo University, Pretoria, South Africa

Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection

Phase 4

Completed

Conditions: HIV

Interventions: Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir (TDF)
Drug: Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Drug: Famotidine (FAM)

First Posted Date: 2010-11-02

Last Posted Date: 2012-08-31

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 25

Registration Number: NCT01232127

Locations: 🇬🇧
Local Institution, London, Greater London, United Kingdom

Tenofovir, Emtricitabine, Efavirenz and Atazanavir Pharmacokinetics in the Aging HIV-Infected Population

Completed

Conditions: Human Immunodeficiency Virus

Interventions: Drug: tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)
Drug: tenofovir/emtricitabine (TDF/FTC)
Drug: Atazanavir (ATV)
Procedure: Phlebotomy
Drug: Ritonavir

First Posted Date: 2010-08-11

Last Posted Date: 2014-12-02

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 85

Registration Number: NCT01180075

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

Phase 3

Completed

Conditions: HIV

Interventions: Drug: Tenofovir/Emtricitabine
Drug: Atazanavir
Drug: Atazanavir/Ritonavir
Drug: Lopinavir/ritonavir

First Posted Date: 2009-10-29

Last Posted Date: 2017-05-11

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 710

Registration Number: NCT01003990

Locations: 🇵🇷
Clinical Research Puerto Rico, Inc., San Juan, Puerto Rico
🇺🇸
Sbma Research, Llc, Miami Beach, Florida, United States
🇺🇸
St Francis Memorial Hospital, San Francisco, California, United States

and more 12 locations

Pharmacokinetic and Safety Study of Raltegravir and Atazanavir in a Once Daily Dose Regimen in HIV-1 Infected Patients

Phase 2

Completed

Conditions: HIV Infections
HIV Infection

Interventions: Drug: raltegravir QD
Drug: atazanavir
Drug: lamivudine (or emtricitabine)

First Posted Date: 2009-07-22

Last Posted Date: 2020-11-12

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 20

Registration Number: NCT00943540

Locations: 🇳🇱
Rijnstate Hospital Arnhem, Arnhem, Netherlands
🇳🇱
Radboud University Medical Centre Nijmegen, Nijmegen, Netherlands
🇳🇱
Erasmus Medical Center Rotterdam, Rotterdam, Netherlands

and more 1 locations

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