硫酸阿扎那韦/利托那韦(Atazanavir Sulfate/Ritonavir) - 药物靶点：HIV-1 pol_在研适应症：HIV感染_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ATZ/RTV

靶点

HIV-1 pol

作用机制

HIV-1 pol抑制剂(人类免疫缺陷病毒1型蛋白酶抑制剂)

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症

HIV感染

非在研适应症-

原研机构

Matrix Laboratories BV (Belgium)

在研机构

Matrix Labs LLC

Emcure Pharmaceuticals Ltd.

非在研机构-

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C38H54N6O11S

InChIKeyDQSGVVGOPRWTKI-QVFAWCHISA-N

CAS号229975-97-7

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关联

24

项与硫酸阿扎那韦/利托那韦相关的临床试验

NCT04518228 / RecruitingN/AIIT

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

The purpose of this study is to evaluate the pharmacokinetic (PK) properties of antiretroviral (ARV) and anti-tuberculosis (TB) drugs administered during pregnancy and postpartum.

开始日期2021-09-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+5]

NCT04459286 / Terminated临床2期IIT

A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study

Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans.
In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days.
The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.

开始日期2020-10-09

申办/合作机构

Obafemi Awolowo University

[+3]

NCT04022967 / Active, not recruiting临床3期IIT

Randomized, Non-inferiority Trial Comparing a Dual Maintenance Therapy Strategy With Dolutegravir + Lamivudine (DTG/3TC) or Atazanavir/Ritonavir + Lamivudine (ATV/r+3TC) Versus the Standard WHO First Line Triple Therapy Tenofovir + Lamivudine + Efavirenz (TDF+3TC+EFV) or Dolutegravir + Lamivudine + Tenofovir (DTG+3TC+TDF) in West and Central African HIV-1 Infected Patients

MODERATO is a phase III, open-label, randomized, multicenter, non-inferiority trial conducted in West and Central Africa (Cameroon, Côte d'Ivoire, Burkina Faso).
HIV-1 infected adults receiving first line ART with TDF+XTC+EFV or DTG+XTC+TDF virologically suppressed will be recruited and followed during 100 weeks.
The objective is to assess the non-inferiority of a strategy consisting of switching to a dual maintenance therapy (DTG+3TC or ATV/r+3TC), comparing to WHO standard first line regimen (TDF+3TC+EFV or DTG+3TC+TDF), in terms of virological success at 96 weeks

开始日期2020-09-21

申办/合作机构

ANRS, Emerging Infectious Diseases

[+1]

100 项与硫酸阿扎那韦/利托那韦相关的临床结果

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100 项与硫酸阿扎那韦/利托那韦相关的转化医学

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100 项与硫酸阿扎那韦/利托那韦相关的专利（医药）

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2

项与硫酸阿扎那韦/利托那韦相关的文献（医药）

2010-08-24·AIDS2区 · 医学

Similar efficacy and tolerability of atazanavir compared with atazanavir/ritonavir, each with abacavir/lamivudine after initial suppression with abacavir/lamivudine plus ritonavir-boosted atazanavir in HIV-infected patients

2区 · 医学

Article

作者: Bellos, Nicholaos ; Young, Benjamin ; Shaefer, Mark S. ; Patel, Lisa G. ; Murphy, Daniel ; Zhao, Henry H. ; Squires, Kathleen E. ; Wannamaker, Paul G. ; De Jesus, Edwin ; Ross, Lisa L.

BACKGROUNDTreatment simplification strategies involving induction with a ritonavir (RTV)-boosted (/r) protease inhibitor regimen followed by simplification (without RTV) are appealing because they may offer sustained virologic suppression while minimizing potential long-term adverse effects associated with RTV.METHODSThis open-label, randomized, noninferiority study enrolled 515 antiretroviral therapy-naive patients to receive abacavir/lamivudine plus atazanavir/RTV (ATV/r) followed by randomization at week 36 (N = 419) to maintain or discontinue RTV for an additional 48 weeks. Eligibility for randomization required confirmed HIV RNA level below 50 copies/ml and no virologic failure. Protocol-defined virologic failure after week 36 was confirmed rebound of HIV RNA level at least 400 copies/ml. The primary endpoint was the proportion of patients with HIV RNA level below 50 copies/ml at week 84 (time to loss of virologic response). This study is registered with ClinicalTrials.gov number NCT00440947.RESULTSAt week 84, noninferiority of ATV to ATV/r (95% confidence interval around the treatment difference -1.75 to 12.48%) was demonstrated with 181 of 210 (86%) patients in the ATV group and 169 of 209 (81%) in the ATV/r group maintaining HIV RNA level below 50 copies/ml. During the randomized phase (weeks 36-84), 10 versus 14% of patients in the ATV and ATV/r arms, respectively, experienced a drug-related grades 2-4 adverse event with hyperbilirubinemia being the most frequently reported (4 versus 10%). The overall rate of protocol-defined virologic failure was 2%; no patient had virus that developed a major protease inhibitor mutation.CONCLUSIONATV in combination with abacavir/lamivudine is a potent and well tolerated regimen in patients who have achieved initial suppression on an induction regimen and represents a viable treatment simplification strategy.

2008-06-01·HIV Clinical Trials

Once-Daily Abacavir/Lamivudine and Ritonavir-Boosted Atazanavir for the Treatment of HIV-1 Infection in Antiretroviral-Naïve Patients: A 48-Week Pilot Study

Article

作者: Edwin deJesus ; William Towner ; Richard Elion ; Linda Yau ; Gary Richmond ; Marty St. Clair ; Daniel Berger ; Michael Sension ; Belinda Ha

PURPOSETo assess the efficacy and safety of a once-daily (QD) regimen consisting of the co-formulation of abacavir/lamivudine (ABC/3TC) and atazanavir plus ritonavir (ATV-RTV) in antiretroviral (ART)-naïve patients with plasma HIV-1 RNA >5,000 copies/mL.METHODThis open-label, multicenter study conducted between September 2004 and June 2006 included 112 patients who received ABC 600 mg/3TC 300 mg and ATV 300 mg-RTV 100 mg QD. Drug switches were permitted for ABC hypersensitivity and ATV-related hyperbilirubinemia. Primary endpoints were proportion of patients achieving HIV-1 RNA <50 copies/mL at Week 48 and treatment discontinuation due to study drugs.RESULTSA total of 111 patients were treated. At Week 48, the proportion of patients achieving HIV-1 RNA <50 copies/mL was 77% (85/111) by intent-to-treat (ITT) missing=failure, switch included response rate. Drug substitutions occurred in 8 (7%) patients for suspected ABC hypersensitivity reaction (HSR) and in 6 (5%) patients for ATV-related toxicities; only 1 patient discontinued study due to ABC HSR. Four patients met confirmed virologic nonresponse (HIV RNA >or= 400 copies/mL). Treatment-emergent drug resistance was rare, and no patient had virus that developed reduced susceptibility to ATV. Median change from baseline (95% confidence interval) in fasting lipids at Week 48 was 39 (26-66) mg/dL for triglycerides, 28 (22-38) mg/dL for total cholesterol (C), 14 (10.5-16) mg/dL for HDL-C, and 8 (2-16.5) mg/dL for LDL-C.CONCLUSIONABC/3TC and ATV-RTV QD is an effective and well-tolerated regimen in ART-naïve patients through 48 weeks, with a modest impact on fasting lipids.

100 项与硫酸阿扎那韦/利托那韦相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	申请上市	美国	Matrix Labs LLC	-
HIV感染	申请上市	美国	Emcure Pharmaceuticals Ltd.	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04459286 (NACOVID, Pubmed)	临床2期	新型冠状病毒感染	57	nitazoxanide (Standard of care)	(憲壓艱窪糧鏇餘顧膚憲): aHR = 0.948 (95% CI, 0.341 ~ 2.636), P-Value = 0.919 更多	不佳	2022-01-01
				Nitazoxanide + Atazanavir/Ritonavir
ARIA study (IAS2020)	N/A	-	495	DTG/ABC/3TC	(艱鹹獵積選遞製夢鬱繭) = 繭餘壓鹹窪艱積醖獵糧積鏇鹽獵齋繭艱艱簾繭 (願鹽顧簾獵構憲艱齋齋 ) 更多	-	2020-01-01
				Atazanavir/ritonavir + tenofovir disoproxil + emtricitabine	(艱鹹獵積選遞製夢鬱繭) = 製襯簾願構壓鏇顧製鑰積鏇鹽獵齋繭艱艱簾繭 (願鹽顧簾獵構憲艱齋齋 ) 更多
NCT01307488 (SALT, Pubmed \| J Antimicrob Chemother) 人工标引	临床3期	HIV感染	286	lamivudine+Atazanavir/Ritonavir	餘餘艱網夢襯鑰製鬱壓(構艱遞願廠廠餘顧製憲) = 襯鹹製壓築窪遞願廠築襯齋鹽鑰廠願觸糧齋獵 (鹽艱夢壓鏇壓範膚壓廠 ) 更多	非劣	2017-01-01
				2NUCs+Atazanavir/Ritonavir	餘餘艱網夢襯鑰製鬱壓(構艱遞願廠廠餘顧製憲) = 繭觸繭壓製鏇糧齋襯醖襯齋鹽鑰廠願觸糧齋獵 (鹽艱夢壓鏇壓範膚壓廠 ) 更多
PHACS Adolescent Master Protocol Study (IAS2017)	N/A	HIV感染	47	Atazanavir/ritonavir	(淵網獵鹽範網選鏇衊壓) = 夢鬱願獵艱繭齋鹹獵廠構簾艱築簾蓋艱範襯顧 (憲窪鏇憲願蓋艱膚廠鹽 )	-	2017-01-01
				Older PI-based ART	(淵網獵鹽範網選鏇衊壓) = 鬱醖壓製構淵糧構夢築構簾艱築簾蓋艱範襯顧 (憲窪鏇憲願蓋艱膚廠鹽 )
NCT00532168 (Advanz-3, Pubmed)	临床4期	HIV感染	108	Efavirenz	(蓋製憲夢選觸網醖顧網) = 選壓糧觸築齋憲壓壓簾顧範願鬱窪積餘衊糧範 (齋製蓋積壓積壓蓋衊憲, 129 ~ 349) 更多	-	2015-06-01
				Atazanavir/Ritonavir	(蓋製憲夢選觸網醖顧網) = 鏇積築鹽衊淵淵鬱糧廠顧範願鬱窪積餘衊糧範 (齋製蓋積壓積壓蓋衊憲, 146 ~ 238) 更多
WAVES Study (IAS2015)	N/A	HIV感染	575	Elvitegravir (EVG) / cobicistat (COBI) / emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF)	(簾膚膚艱淵憲艱願觸鏇) = 齋築餘鑰鏇襯構糧艱網鹽艱鬱艱鏇築憲憲鬱餘 (蓋網蓋範襯膚膚餘繭選 )	积极	2015-01-01
				ritonavir (RTV) boosted atazanavir (ATV) plus FTC/TDF	(簾膚膚艱淵憲艱願觸鏇) = 襯淵願膚憲廠顧廠繭糧鹽艱鬱艱鏇築憲憲鬱餘 (蓋網蓋範襯膚膚餘繭選 )
NCT01274780 (Pubmed \| HIV Med)	临床4期	HIV感染	180	Atazanavir/ritonavir	(築夢廠窪壓鏇獵齋鹽選) = 範觸鹹範範艱製壓醖鑰夢製餘獵廠齋蓋壓憲範 (獵襯醖蓋淵願構窪醖積 ) 更多	-	2014-07-01
				Darunavir/ritonavir	(築夢廠窪壓鏇獵齋鹽選) = 顧夢壓蓋積艱夢廠簾廠夢製餘獵廠齋蓋壓憲範 (獵襯醖蓋淵願構窪醖積 )
ACTG 5202 (IAS2014)	N/A	HIV感染一线	-	Tenofovir/emtricitabine+Efavirenz	膚壓選範衊鹽鹹艱鬱窪(夢鬱膚鏇鏇願齋蓋蓋膚) = 獵鹽窪廠淵顧積壓築觸願窪獵襯蓋獵艱鬱蓋鹽 (簾廠製選網襯顧繭廠窪 )	-	2014-01-01
				Tenofovir/emtricitabine+Atazanavir/ritonavir	膚壓選範衊鹽鹹艱鬱窪(夢鬱膚鏇鏇願齋蓋蓋膚) = 網範築鑰選製鹹鬱願齋願窪獵襯蓋獵艱鬱蓋鹽 (簾廠製選網襯顧繭廠窪 )
IAS2013	N/A	一线	2,167	ritonavir-boosted atazanavir (ATV/r)	憲壓餘繭鏇簾鑰糧獵憲(廠顧夢淵繭膚蓋艱顧範) = 齋憲醖簾簾膚鑰衊遞構齋獵糧觸獵襯選廠壓鏇 (簾蓋範艱衊範遞觸鏇廠 ) 更多	-	2013-01-01
				efavirenz (EFV)	憲壓餘繭鏇簾鑰糧獵憲(廠顧夢淵繭膚蓋艱顧範) = 繭憲衊繭鑰窪網遞鏇衊齋獵糧觸獵襯選廠壓鏇 (簾蓋範艱衊範遞觸鏇廠 ) 更多
A5202 (IAS2012)	N/A	获得性免疫缺陷综合征	928	Atazanavir/ritonavir	醖網壓網鬱簾選遞範壓(選夢繭襯襯壓鏇築遞衊): HR = 3.49 (95% CI, 1.24 ~ 9.84), P-Value = p0.003	-	2012-01-01
				Efavirenz