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 to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Atazanavir
Drug: Cobicistat
Drug: Atazanavir/Cobicistat Mini-tablet

First Posted Date: 2022-02-11

Last Posted Date: 2022-10-31

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 42

Registration Number: NCT05236738

Locations: 🇺🇸
Local Institution - 0001, Miami, Florida, United States

Antiviral Agents Against COVID-19 Infection

Phase 2

Completed

Conditions: COVID-19

Interventions: Drug: Daclatasvir 60 mg
Drug: Placebo Sofusbuvir + Daclatasvir 60 mg
Drug: Sofusbuvir + Daclastavir 60 mg
Drug: Placebo Daclatasvir 60 mg
Drug: Atazanavir
Drug: Placebo Atazanavir

First Posted Date: 2020-07-13

Last Posted Date: 2024-03-22

Lead Sponsor: Hospital do Coracao

Target Recruit Count: 256

Registration Number: NCT04468087

Locations: 🇧🇷
Hospital do Coracao, Sao Paulo, SP, Brazil

A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time

Phase 1

Completed

Conditions: Healthy Participants

Interventions: Drug: Atazanavir/Cobicistat
Drug: Reyataz Atazanavir
Drug: Cobicistat

First Posted Date: 2020-02-10

Last Posted Date: 2021-11-23

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 34

Registration Number: NCT04263350

Locations: 🇺🇸
PPD Development, LP, Austin, Texas, United States

Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials

Phase 1

Completed

Conditions: Hematological Malignancies
Solid Tumor

Interventions: Drug: Belinostat
Drug: Atazanavir

First Posted Date: 2019-12-04

Last Posted Date: 2023-05-03

Lead Sponsor: Acrotech Biopharma Inc.

Target Recruit Count: 8

Registration Number: NCT04184869

Locations: 🇺🇸
John Wayne Cancer Institute @ Providence Saint John's Health Center, Santa Monica, California, United States

ANRS 12372 MODERATO Study

Phase 3

Active, not recruiting

Conditions: HIV-1-infection

Interventions: Drug: tenofovir + lamivudine +efavirenz or dolutegravir + lamivudine + tenofovir
Drug: atazanavir boosted with ritonavir
Drug: dolutegravir
Drug: Lamivudine

First Posted Date: 2019-07-17

Last Posted Date: 2023-09-06

Lead Sponsor: ANRS, Emerging Infectious Diseases

Target Recruit Count: 480

Registration Number: NCT04022967

Locations: 🇨🇮
Service des Maladies Infectieuses et Tropicales (SMIT), CHU de Treichville, Abidjan, Côte D'Ivoire
🇧🇫
Service de médecine interne, CHU Yalgado Ouédraogo, Ouagadougou, Burkina Faso
🇧🇫
Hôpital de jour, Service des maladies infectieuses, CHU Sourô Sanou, Bobo-Dioulasso, Burkina Faso

and more 2 locations

Pharmacokinetics of Atazanavir in Special Populations

Completed

Conditions: HIV/AIDS
Tuberculosis

Interventions: Drug: Atazanavir 300mg/ Ritonavir 100 mg once daily
Drug: Atazanavir 250 mg / ritonavir 80 mg

First Posted Date: 2019-04-22

Last Posted Date: 2023-05-09

Lead Sponsor: University of Liverpool

Target Recruit Count: 32

Registration Number: NCT03923231

Locations: 🇺🇬
Infectious Diseases Institute, Kampala, Uganda
🇺🇬
Joint Clinical Research Centre, Kampala, Uganda
🇿🇦
Desmond Tutu HIV Foundation, Cape Town, Western Cape, South Africa

and more 1 locations