PC-515(PC-515) - _专利_临床

概要

基本信息

药物类型

小分子化药

别名

Carraguard、Lambda-carrageenan、PC 515

靶点-

作用方式

抑制剂

作用机制

病毒内化抑制剂

治疗领域

免疫系统疾病感染泌尿生殖系统疾病+ [1]

在研适应症-

非在研适应症

获得性免疫缺陷综合征沙眼衣原体感染淋病+ [5]

原研机构

The Population Council, Inc.

在研机构-

非在研机构

The Population Council, Inc.

权益机构-

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

项与 PC-515 相关的临床试验

NCT00213083

/ Completed临床3期IIT

Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard® in Preventing HIV Seroconversion in Women

The purposes of this study are to determine whether Carraguard® Gel can prevent the transmission of HIV when used during vaginal intercourse, and to confirm that the gel is safe for vaginal use.

开始日期2004-04-01

申办/合作机构

The Population Council, Inc.

[+1]

NCT00213005

/ Completed临床1期IIT

A Phase 1 Safety and Acceptability Study of Carraguard® Among HIV Positive Women and Men in Durban, South Africa

The study objectives were to assess the mucosal safety of Carraguard® gel when applied vaginally once per day for 14 days by sexually abstinent and sexually active, HIV-positive women; to evaluate the effect of Carraguard® gel on the vaginal flora in these women; to evaluate the effect of Carraguard® gel on shedding of HIV-1 in the genital tract of these women; to evaluate the safety of Carraguard® gel when applied directly to the penis once per day for 7 days by sexually abstinent, HIV-positive men; to assess whether symptoms reported by female and male participants during the study may be related to the use of Carraguard® gel; and to examine dimensions of the acceptability of, and compliance with, the study and placebo products.

开始日期2002-06-01

申办/合作机构

The Population Council, Inc.

[+2]

NCT00213057

/ Completed临床1期IIT

A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai

The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted.
The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.

开始日期2001-06-01

申办/合作机构

The Population Council, Inc.

[+2]

100 项与 PC-515 相关的临床结果

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100 项与 PC-515 相关的转化医学

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100 项与 PC-515 相关的专利（医药）

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166

项与 PC-515 相关的文献（医药）

2025-05-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Carrageenan-xanthan gum composite gel achieves the elimination of bitterness and easy swallowability of Coptis chinensis based on electrostatic induction and interpenetrating network interaction

Article

作者: Lu, Tai ; Chen, Zhencai ; Han, Li ; Liu, Qian ; Han, Xue ; Lin, Junzhi ; Qiu, Min ; Tian, Yin ; Zhang, Yifan ; Zhang, Dingkun ; Ke, Xiumei ; Song, Jiao

Natural polysaccharides possess the potential function of masking bitterness due to their three-dimensional network structures. However, they also have relatively high mechanical strength, which is not conducive to swallowing. Taking Coptis chinensis as an example, this study developed a composite gel composed of 0.17 % iota-carrageenan, 0.13 % lambda-carrageenan and 0.17 % xanthan gum. This composite gel can eliminate the bitterness and achieve good swallowability. Compared with the Coptis chinensis decoction, the bitterness of this gel is reduced by 60 %. Its hardness and crispness are only 1 % and 0.7 % of those of iota-carrageenan used alone. In addition, 60 % of the berberine in the composite gel can be released in artificial gastric juice within 10 min, and it has no significant impact on the hypoglycemic effects of Coptis chinensis. Further mechanism studies revealed that the sulfate group of iota-carrageenan disperses the electron cloud density of the bitter group of alkaloids through electrostatic induction, thus realizing the masking of bitterness. Meanwhile, the formation of an interpenetrating network structure between xanthan gum and carrageenan improves the swallowability. This study has developed a Coptis chinensis composite gel with excellent taste and easy swallowability, providing evidence for expanding the new applications of polysaccharides in masking taste.

2024-12-01·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Lambda carrageenan displays antiviral activity against the infectious pancreatic necrosis virus (IPNV) by inhibiting viral replication and enhancing innate immunity in salmonid cells

Article

作者: Espinoza, Daniela ; Valdés, Natalia ; Laporte, Daniel ; Sandino, Ana María ; Moenne, Alejandra ; Martínez, Fabián ; Imarai, Mónica

Sulfated polysaccharide lambda carrageenan (λ-CGN) was evaluated for its antiviral effect against IPNV using the in vitro infection model of CHSE-214 salmonid cells. A plaque reduction lysis assay revealed that λ-CGN has an IC₅₀ of 0.9 μg⋅mL^-1, CC₅₀ > 128 μg⋅mL^-1 and a Selectivity Index (SI) > 142. In comparison, iota, kappa carrageenans and lambda oligo-carrageenan (λ-OC) were less effective than λ-CGN against IPNV. λ-CGN showed no virucidal activity when applied directly to viral particles. Time of addition experiments showed that pre-treatment, co-treatment, and post-treatment with λ-CGN significantly reduced viral RNA copies in the cell supernatant. Additionally, a decrease in intracellular viral RNA was observed with pre-treatment and post-treatment, indicating an impact on different stages of viral replication. Polyacrylamide gel electrophoresis of IPNV genomic RNA in presence of λ-CGN showed a reduction in the level of viral genomic RNA. Confocal microscopy confirmed the intracellular localization of λ-CGN, suggesting that λ-CGN may inhibit the synthesis of IPNV genomic RNA. Moreover, cells pre-treated with λ-CGN showed an increased expression of innate immunity genes CXCL11, IL1β, IFNa, and IRF3. These findings highlight the need for further research to confirm the in vivo pharmacological potential of λ-CGN as a new antiviral agent in salmonids.

2024-09-01·SEXUALLY TRANSMITTED INFECTIONS

Safety of carrageenan-based gels as preventive microbicides: a narrative review

Review

作者: El-Zein, Mariam ; Laurie, Cassandra ; Franco, Eduardo L

Background:

Carrageenan-containing gels researched for the prevention of sexually transmitted infections (STIs) have shown promising results for human papillomavirus prevention in women, but not in men. We conducted a narrative review to assess the safety of these gels for genital use.

Methods:

We searched PubMed using MeSH terms and keywords on 5 November 2023. Title/abstract of articles were screened to identify relevant ones. Full-text screening determined eligibility: empirical study evaluating safety of carrageenan-containing gel(s) for genital use.

Results:

Of the 125 identified records, 15 were eligible, comprising 14 (10 randomised controlled trials and 4 cohorts) unique study populations. Studies included women only (n=11), men only (n=1) or both (n=3); number of participants ranged from 4 to 6202. Safety was assessed for vaginal (n=13), penile (n=3) and anal use (n=2). Most studies assessed safety of Carraguard (53%), followed by Divine9 (14%), and one each of iota-carrageenan gel, lambda-carrageenan gel, Carvir, PC-6500 (griffithsin and carrageenan) and PC-1005 (MIV-150/zinc acetate/carrageenan). Safety assessment relied on self-report (80.0%), testing for STIs (53.3%), investigator-identified genital findings (93.3%) and/or testing for changes in genital flora (60.0%). Adverse events (AEs) were described by investigators as mostly mild, (mostly) comparable between groups, not observed and/or not significant for vaginal and penile use. Only one study, assessing anal use of carrageenan, reported a significantly higher proportion of AEs in the carrageenan compared with placebo group.

Conclusions:

Carrageenan-based gels are generally well tolerated for vaginal and penile, but not anal use. Studies on carrageenan gel’s safety for anal use are scarce.

100 项与 PC-515 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
获得性免疫缺陷综合征	临床3期	南非	The Population Council, Inc.	2004-04-01
HIV血清阳性	临床3期	南非	The Population Council, Inc.	2004-04-01
单纯疱疹	临床2期	泰国	The Population Council, Inc.	2000-02-01
HIV感染	临床2期	泰国	The Population Council, Inc.	2000-02-01
沙眼衣原体感染	临床2期	南非	The Population Council, Inc.	1999-10-01
淋病	临床2期	南非	The Population Council, Inc.	1999-10-01
梅毒	临床2期	南非	The Population Council, Inc.	1999-10-01
滴虫性阴道炎	临床2期	南非	The Population Council, Inc.	1999-10-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00213083 (Pubmed \| Lancet)	临床3期	HIV感染	6,202	Carraguard	築膚艱鑰齋壓繭憲淵構(壓鏇繭衊願齋構廠淵夢) = 製蓋糧鬱夢獵製蓋壓簾網夢鬱範壓齋襯淵壓願 (淵遞廠蓋觸膚遞觸鹽願, 2.8 ~ 3.9) 更多	不佳	2008-12-06
NCT00213083 (Pubmed \| Lancet)	临床3期	HIV感染	6,202	Placebo (methylcellulose)	築膚艱鑰齋壓繭憲淵構(壓鏇繭衊願齋構廠淵夢) = 壓鹹淵艱窪鹽觸製鏇糧網夢鬱範壓齋襯淵壓願 (淵遞廠蓋觸膚遞觸鹽願, 3.2 ~ 4.4) 更多	不佳	2008-12-06
IAS2004	N/A	-	55	Carraguard (2.5% methyl cellulose placebo)	鏇夢衊襯衊製願淵繭廠(壓壓遞構獵淵積糧構壓) = 鏇淵繭鬱願窪選觸繭鏇襯鏇製鑰選觸糧廠鬱醖 (淵窪襯膚選夢糧醖繭襯 ) 更多	-	2004-01-01
IAS2004	N/A	HIV感染	-	Carraguard	夢鹹遞襯簾築鑰糧構餘(壓鏇蓋選膚齋網願衊遞) = 壓糧鏇鏇願餘窪廠窪淵淵獵範廠糧淵餘壓襯衊 (築鑰壓餘觸遞獵淵願廠 ) 更多	-	2004-01-01
IAS2004	N/A	HIV感染	-	Placebo (methyl cellulose)	夢鹹遞襯簾築鑰糧構餘(壓鏇蓋選膚齋網願衊遞) = 齋廠衊顧遞顧糧醖齋積淵獵範廠糧淵餘壓襯衊 (築鑰壓餘觸遞獵淵願廠 ) 更多	-	2004-01-01
IAS2004	N/A	HIV感染	194	microbicide (HIV-discordant couples)	網顧淵憲餘網觸願蓋製(構襯齋構願遞餘廠範膚) = 鬱淵蓋淵齋簾願餘鏇齋簾餘顧範鏇製積糧窪製 (鹹顧鬱醖繭鬱願繭糧襯 )	-	2004-01-01
IAS2002	N/A	尿潴留	-	Carraguard	壓壓積顧夢築製襯壓製(襯範齋鹽淵鹽憲衊齋獵) = 艱艱願鹽鬱顧齋憲鬱壓醖膚鬱獵選遞鑰襯衊鏇 (築窪製糧壓鏇鏇鹹襯窪 ) 更多	-	2002-01-01
IAS2002	N/A	-	400	Carraguard™	選鏇窪艱膚鹹淵鏇構製(壓網壓願鹽夢蓋蓋衊選) = 選觸鹽網夢憲鏇繭艱餘襯鹹餘觸繭構鹹憲選顧 (獵淵醖壓範憲獵衊淵願 ) 更多	-	2002-01-01
IAS2002	N/A	-	400	Placebo (methyl cellulose)	選鏇窪艱膚鹹淵鏇構製(壓網壓願鹽夢蓋蓋衊選) = 積遞憲遞鬱憲齋範醖選襯鹹餘觸繭構鹹憲選顧 (獵淵醖壓範憲獵衊淵願 ) 更多	-	2002-01-01