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

Microboosting of Atazanavir 300 mg With 50 mg Versus 100mg Ritonavir Daily in HIV-infected Patients: a Pharmacokinetic Study

Phase 1

Completed

Conditions: HIV Infection

Interventions: Drug: atazanavir 300mg boosted with ritonavir 50 mg

First Posted Date: 2014-01-14

Last Posted Date: 2015-09-22

Lead Sponsor: Ottawa Hospital Research Institute

Target Recruit Count: 12

Registration Number: NCT02034838

Locations: 🇨🇦
The Ottawa Hospital, Ottawa, Ontario, Canada

Evaluation of the Efficacy and Safety Between Two Antiretroviral Regimens, in HIV-1-infected Treatment-naïve Subjects With Low CD4 Counts

Phase 4

Completed

Conditions: HIV-1 Infection
Immunosuppression-related Infectious Disease

Interventions: Drug: ATAZANAVIR
Drug: DARUNAVIR

First Posted Date: 2013-08-26

Last Posted Date: 2018-01-12

Lead Sponsor: Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Target Recruit Count: 120

Registration Number: NCT01928407

Locations: 🇫🇷
Hopital Saint Antoine, Paris, France
🇫🇷
Hopital Le Bocage, Dijon, France
🇫🇷
C.H.D de Vendee, La Roche Sur Yon, France

and more 26 locations

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Phase 3

Completed

Conditions: Infection, Human Immunodeficiency Virus
HIV Infections

Interventions: Drug: Dolutegravir/abacavir/lamivudine FDC
Drug: Atazanavir
Drug: Ritonavir
Drug: Tenofovir/emtricitabine FDC

First Posted Date: 2013-07-29

Last Posted Date: 2024-02-20

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 499

Registration Number: NCT01910402

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

Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat

Phase 1

Completed

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

Interventions: Drug: Atazanavir/Cobicistat FDC
Drug: Atazanavir
Drug: Cobicistat

First Posted Date: 2013-04-23

Last Posted Date: 2014-08-29

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 64

Registration Number: NCT01837719

Locations: 🇺🇸
Ppd Development, Inc., Austin, Texas, United States

Study to Evaluate a HIV Drug for the Treatment of HIV Infection

Phase 2

Completed

Conditions: Infection, Human Immunodeficiency Virus
HIV Infections

Interventions: Drug: Atazanavir
Drug: BMS-955176
Drug: Placebo matching with BMS-955176
Drug: Tenofovir
Drug: Ritonavir
Drug: Emtricitabine

First Posted Date: 2013-03-04

Last Posted Date: 2019-11-25

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 107

Registration Number: NCT01803074

Locations: 🇩🇪
GSK Investigational Site, Berlin, Germany

Effects of Gastric pH on the Pharmacokinetics of Atazanavir

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ritonavir-boosted Atazanavir
Drug: Ritonavir-boosted Atazanavir plus Rabeprazole
Drug: Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride

First Posted Date: 2013-01-03

Last Posted Date: 2015-04-28

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 8

Registration Number: NCT01759875

Locations: 🇺🇸
Clinical Research Center, UCSF, San Francisco, California, United States

Safety Sudy of Atazanavir Boosted With Ritonavir in the Treatment of HIV Infection in Pediatric Patients

Phase 4

Completed

Conditions: HIV, Pediatric

Interventions: Drug: Atazanavir
Drug: Ritonavir

First Posted Date: 2012-09-25

Last Posted Date: 2018-04-27

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 108

Registration Number: NCT01691794

Locations: 🇺🇸
Children'S Medical Center Of Dallas, Dallas, Texas, United States
🇺🇸
Phoenix Children'S Hospital, Phoenix, Arizona, United States
🇿🇦
Local Institution, Cape Town, Western CAPE, South Africa

and more 1 locations

Atazavanir/Ritonavir-based HAART in Children

Phase 2

Completed

Conditions: HIV

Interventions: Drug: boosted atazanavir (ATV/r)

First Posted Date: 2012-08-02

Last Posted Date: 2014-08-26

Lead Sponsor: The HIV Netherlands Australia Thailand Research Collaboration

Target Recruit Count: 20

Registration Number: NCT01656109

Locations: 🇹🇭
Department of Pediatrics Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
🇹🇭
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand
🇹🇭
Division of Infectious Diseases Department of Pediatrics Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC

Phase 3

Terminated

Conditions: HIV

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

First Posted Date: 2012-06-15

Last Posted Date: 2024-01-10

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 3

Registration Number: NCT01620944

Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone

Phase 3

Withdrawn

Conditions: HIV

Interventions: Drug: Darunavir
Drug: Atazanavir
Drug: Ritonavir
Drug: Optimized NRTI backbone

First Posted Date: 2012-05-24

Last Posted Date: 2023-12-19

Lead Sponsor: Bristol-Myers Squibb

Registration Number: NCT01605084

Locations: 🇺🇸
Anthony M. Mills Md Inc, Los Angeles, California, United States
🇺🇸
Metropolis Medical Pc, San Francisco, California, United States
🇺🇸
Be Well Medical Center, Berkley, Michigan, United States

and more 9 locations

Drug Development Updates

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