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

ATV/Ritonavir Nevirapine Interaction (USPAC)

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: Nevirapine + Atazanavir/Ritonavir
Drug: Atazanavir + Ritonavir
Drug: Nevirapine

First Posted Date: 2005-09-13

Last Posted Date: 2011-04-08

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 46

Registration Number: NCT00162149

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

Atazanavir or Boosted Atazanavir Substitution for Ritonavir Boosted PI in Patients With Hyperlipidemia

Phase 3

Completed

Conditions: Hyperlipidemia
HIV Infections

First Posted Date: 2005-09-12

Last Posted Date: 2011-07-21

Lead Sponsor: Stanford University

Target Recruit Count: 60

Registration Number: NCT00160329

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

Phase 4

Completed

Conditions: HIV-Associated Lipodystrophy Syndrome

Interventions: Drug: Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)
Drug: continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

First Posted Date: 2005-08-26

Last Posted Date: 2010-05-07

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 219

Registration Number: NCT00135356

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

Efficacy and Safety of Tenofovir DF/Atazanavir Enhanced With Low Dose of Ritonavir in HIV-Infected Patients

Phase 2

Terminated

Conditions: HIV Infections

First Posted Date: 2005-07-22

Last Posted Date: 2005-07-28

Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Target Recruit Count: 50

Registration Number: NCT00122577

Locations: 🇫🇷
Service d'Immunologie clinique Hopital Europeen Georges Pompidou, Paris, France

Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Efavirenz
Drug: Abacavir/Lamivudine
Drug: Atazanavir
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Abacavir/Lamivudine placebo
Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo
Drug: Ritonavir

First Posted Date: 2005-07-12

Last Posted Date: 2018-10-12

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

Target Recruit Count: 1864

Registration Number: NCT00118898

Locations: 🇺🇸
Univ of Iowa Hosp and Clinic (1504), Iowa City, Iowa, United States
🇺🇸
Vanderbilt Therapeutics CRS (3652), Nashville, Tennessee, United States
🇺🇸
SUNY - Buffalo (Rochester) (1102), Buffalo, New York, United States

and more 49 locations

Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults

Not Applicable

Completed

Conditions: HIV Infections
Tuberculosis

Interventions: Drug: Atazanavir
Drug: Rifampin
Drug: Ritonavir

First Posted Date: 2004-11-17

Last Posted Date: 2021-11-01

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

Target Recruit Count: 18

Registration Number: NCT00096850

Locations: 🇺🇸
Vanderbilt Therapeutics CRS, Nashville, Tennessee, United States
🇺🇸
The Ohio State Univ. AIDS CRS, Columbus, Ohio, United States
🇺🇸
Stanford CRS, Palo Alto, California, United States

Prospective Evaluation of Anti-retroviral Combinations for Treatment Naive, HIV Infected Persons in Resource-limited Settings

Phase 4

Completed

Conditions: HIV Infections

Interventions: Drug: Efavirenz
Drug: Atazanavir
Drug: Didanosine (enteric-coated)
Drug: Lamivudine/Zidovudine
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Emtricitabine

First Posted Date: 2004-06-08

Last Posted Date: 2018-10-10

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

Target Recruit Count: 1571

Registration Number: NCT00084136

Locations: 🇺🇸
University of Texas, Galveston, Galveston, Texas, United States
🇲🇼
College of Med. JHU CRS, P.O. Box 1131, Blantyre, Malawi
🇿🇼
UZ-Parirenyatwa CRS, AIDS Research Unit P.O. Box A178, Harare, Zimbabwe

and more 39 locations

Atazanavir/Ritonavir Maintenance Therapy

Not Applicable

Completed

Conditions: HIV Infections

First Posted Date: 2004-06-07

Last Posted Date: 2021-11-01

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

Target Recruit Count: 36

Registration Number: NCT00084019

Locations: 🇺🇸
University of Pittsburgh CRS, Pittsburgh, Pennsylvania, United States
🇺🇸
Dallas VAMC, Dallas, Texas, United States
🇺🇸
University of Colorado Hospital CRS, Aurora, Colorado, United States

and more 9 locations

A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV

Phase 4

Completed

Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection

First Posted Date: 2004-05-10

Last Posted Date: 2017-05-24

Lead Sponsor: GlaxoSmithKline

Registration Number: NCT00082394

Locations: 🇲🇽
GSK Investigational Site, Monterrey, Nuevo León, Mexico

Preventing Sexual Transmission of HIV With Anti-HIV Drugs

Phase 3

Completed

Conditions: HIV Infections

Interventions: Drug: Atazanavir
Drug: Didanosine
Drug: Efavirenz
Drug: Emtricitabine/Tenofovir disoproxil fumarate
Drug: Lamivudine
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Drug: Stavudine
Drug: Tenofovir disoproxil fumarate
Drug: Zidovudine/Lamivudine

First Posted Date: 2003-12-17

Last Posted Date: 2021-11-05

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

Target Recruit Count: 3526

Registration Number: NCT00074581

Locations: 🇺🇸
Fenway Community Health Ctr. CRS, Boston, Massachusetts, United States
🇧🇼
Gaborone CRS, Gaborone, Botswana
🇧🇷
Hospital Geral de Nova Iguaçu CRS (HGNI CRS), Nova Iguacu, Rio De Janeiro, Brazil

and more 14 locations

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