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【drug-news】阻断HIV传染药物实验因安全问题而被叫停

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Tests of drug to block H.I.V. infection are halted over safety
By Lawrence K. Altman
Published: February 1, 2007

Efforts to develop a topical microbicide to prevent H.I.V. infection during sex suffered a surprising setback Wednesday when researchers announced that they had stopped two full-scale trials for safety reasons.

The trials, in Africa and India, involved a chemical, cellulose sulfate or Ushercell, and were the second failure of a potential microbicide in a full-scale trial in recent years. In one of the latest trials, a standard check by an independent scientific committee found an increased risk of H.I.V. infection among women who used cellulose sulfate compared with those who used a placebo gel.

In 2000, a large full-scale trial showed that the only other microbicide candidate, nonoxynol-9, was unsafe when it had been expected to be effective. Subjects in that trial developed a higher incidence of H.I.V. infection, presumably through ulcers caused by chemical irritation.

Wednesday, AIDS researchers at the World Health Organization, the United Nations AIDS program and other organizations expressed hope that at least one of three other potential microbicides undergoing full-scale testing would prove to be safe and effective. The others are Pro 2000 by Indevus Pharmaceuticals, BufferGel by ReProtect and Carraguard, whose trademark is held by the Population Council.

"While the closing of these trials is a profound disappointment for the microbicide field, we cannot let it paralyze us," said Dr. Zeda Rosenberg, chief executive of the nonprofit International Partnership for Microbicides in Silver Spring, Md.

In the absence of an AIDS vaccine, specialists say development of a microbicide is a public health priority, mainly to protect the many women in poor countries whose partners refuse to use condoms. Such protection could take the form of a gel, cream, film, tablet or sponge that could be inserted into the vagina or rectum.

The study that led to stopping the trials involved 1,333 participants in Benin, South Africa and Uganda. Conrad, a health research organization in Arlington, Va., conducted the study.

Conrad said the independent committee found more new H.I.V. infections among those who used cellulose sulfate than among those who used an inactive gel, but did not report any numbers. Final numbers are expected in March, a spokeswoman for Conrad said.

Family Health International of Research Triangle Park, N.C., conducted the second trial involving 1,700 participants in Nigeria. The study found neither a benefit in preventing H.I.V. infection nor an increased risk of developing it.

So, given the adverse findings in the Conrad trial, "the responsible course of action was to halt our study" also, said Dr. Vera Halpern, the principal investigator of the Family Health International trial.

An ideal microbicide would work in three ways. First, it would kill H.I.V. in the vagina and cervix. Second, the microbicide would prevent any virus that escaped from attaching to a woman's cells, the way the virus starts to infect. Third, for any virus that did enter cells, the microbicide would block an enzyme, reverse transcriptase, that the virus needs to replicate.

The Bill and Melinda Gates Foundation and the Agency for International Development paid $20 million for the two latest studies.

In speaking at the 16th International AIDS Conference in Toronto in August, Bill and Melinda Gates were enthusiastic about the prospects of developing a microbicide.

Wednesday, Dr. Nicholas Hellmann, acting director of the foundation's H.I.V. and tuberculosis program, affirmed the optimism.

"We remain hopeful that a safe and effective microbicide will be developed," Hellmann said, adding that the foundation was still committed to supporting research on microbicides and other prevention methods.

The new findings were surprising, researchers said, because 11 smaller trials of more than 500 women conducted since 1999 showed that cellulose sulfate was safe. The chemical, which was developed as Ushercell by Polydex Pharmaceuticals in Toronto, was active against H.I.V. in laboratory tests.

Dr. Peter Piot, the executive director of Unaids in Geneva, said the new findings were puzzling because there appeared to be no biological explanation for the failure of cellulose sulfate, as there was in the case of nonoxynol-9 and the ulcers associated with its use.

Finding new drugs like a microbicide often can be a process of trial and error, and requires scientifically rigorous trials, Piot said.

He speculated that one of the antiretroviral drugs used to treat AIDS might be needed for an effective microbicide. The world needs a microbicide because "the stakes are so high," Piot said.

http://www.iht.com/articles/2007/02/01/healthscience/web.0201aids.php

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Tests of drug to block H.I.V. infection are halted over safety
By Lawrence K. Altman
Published: February 1, 2007
阻断HIV传染药物实验因安全问题而被叫停
Efforts to develop a topical microbicide to prevent H.I.V. infection during sex suffered a surprising setback Wednesday when researchers announced that they had stopped two full-scale trials for safety reasons.一种用以预防性生活中H.I.V.感染的局部抗生素，在星期三遇到了巨大挫折，研究人员宣布因为安全原因他们已经全面停止了试验。
The trials, in Africa and India, involved a chemical, cellulose sulfate or Ushercell, and were the second failure of a potential microbicide in a full-scale trial in recent years. In one of the latest trials, a standard check by an independent scientific committee found an increased risk of H.I.V. infection among women who used cellulose sulfate compared with those who used a placebo gel.
在非洲和印度进行的这些试验涉及到一种化学药品—硫酸盐性纤维素或Ushercell，这是近年来一种可能的抗生素在进行全面试验时遇到的第二次失败。根据独立科学委员会的检验标准，在最近的一个试验中，使用硫酸盐纤维素的女性比使用胶状安慰剂的女性感染 H.I.V的风险增加。
In 2000, a large full-scale trial showed that the only other microbicide candidate, nonoxynol-9, was unsafe when it had been expected to be effective. Subjects in that trial developed a higher incidence of H.I.V. infection, presumably through ulcers caused by chemical irritation.
在2000年，一个大规模的全面试验显示，只有另外一种抗生素 nonoxynol-9与预期效果不同，其存在安全问题。在那个试验中的受试者感染H.I.V.的风险更高，推测可能是通过化学刺激性溃疡引起。
Wednesday, AIDS researchers at the World Health Organization, the United Nations AIDS program and other organizations expressed hope that at least one of three other potential microbicides undergoing full-scale testing would prove to be safe and effective. The others are Pro 2000 by Indevus Pharmaceuticals, BufferGel by ReProtect and Carraguard, whose trademark is held by the Population Council.
在星期三，世界卫生组织、联合国AIDS计划组和其他组织表示，三种其他进行过全面检验的可能抗生素中，至少有一种证明是安全、有效的。其他的包括Indevus制药厂生产的磺酸萘聚合物，ReProtect和Carraguard生产的BufferGel，其商标由人口委员会掌握。
"While the closing of these trials is a profound disappointment for the microbicide field, we cannot let it paralyze us," said Dr. Zeda Rosenberg, chief executive of the nonprofit International Partnership for Microbicides in Silver Spring, Md.
“这些试验的停止令抗生素领域十分失望，但我们不能让这使我们陷入困境”，Silver Spring, Md的非营利性国际抗生素合作组织的首席执行官Zeda Rosenberg博士说。
In the absence of an AIDS vaccine, specialists say development of a microbicide is a public health priority, mainly to protect the many women in poor countries whose partners refuse to use condoms. Such protection could take the form of a gel, cream, film, tablet or sponge that could be inserted into the vagina or rectum.
由于缺乏一种AIDS疫苗，专家称发展一种抗生素首先考虑的是公共健康，主要为了保护那些贫穷国家其伴侣拒绝使用安全套的众多女性。这种保护可以采用能够插入阴道或直肠的凝胶状物，乳剂，薄膜，片剂或海绵状物。
The study that led to stopping the trials involved 1,333 participants in Benin, South Africa and Uganda. Conrad, a health research organization in Arlington, Va., conducted the study.

Conrad said the independent committee found more new H.I.V. infections among those who used cellulose sulfate than among those who used an inactive gel, but did not report any numbers. Final numbers are expected in March, a spokeswoman for Conrad said.
导致这些试验停止的研究涉及到Benin，南非和乌干达的1333名参与者，由Arlington, Va的一个健康研究组织- Conrad进行该研究。Conrad称独立委员会发现，那些使用硫酸盐纤维素的女性比使用惰性凝胶的女性感染新的H.I.V.的数量要多，但是他们没有透露具体数字。Conrad的一个发言人说最后的数字预期在3月公布。
Family Health International of Research Triangle Park, N.C., conducted the second trial involving 1,700 participants in Nigeria. The study found neither a benefit in preventing H.I.V. infection nor an increased risk of developing it.
家庭保健国际研究组织--Triangle Park, N.C.在尼日利亚进行了包括1700参与者的第二次试验。该研究发现，其既对预防H.I.V.没有帮助，但也不会增加H.I.V.的发生风险。
So, given the adverse findings in the Conrad trial, "the responsible course of action was to halt our study" also, said Dr. Vera Halpern, the principal investigator of the Family Health International trial.
因此，如果在Conrad的试验中得到了不利的发现结果，“负责任的做法就是停止我们的研究”，该试验的主要负责人家庭保健国际研究组织的Vera Halpern博士也说。
An ideal microbicide would work in three ways. First, it would kill H.I.V. in the vagina and cervix. Second, the microbicide would prevent any virus that escaped from attaching to a woman's cells, the way the virus starts to infect. Third, for any virus that did enter cells, the microbicide would block an enzyme, reverse transcriptase, that the virus needs to replicate.
一个理想的抗生素应该在三个方面起作用。第一，它可以杀死阴道和子宫颈里面的H.I.V.；第二，这种抗生素可以阻止任何从黏附在女性细胞内逃脱出来的病毒（这种病毒就是通过此方式发动感染）；第三，对于任何进入细胞的病毒来说，抗生素可以阻断一种病毒赖以复制的逆转录酶。
The Bill and Melinda Gates Foundation and the Agency for International Development paid $20 million for the two latest studies.
Bill和Melinda Gates基金会以及国际发展委员会为这两个最新的研究提供了2000万美元的资助。
In speaking at the 16th International AIDS Conference in Toronto in August, Bill and Melinda Gates were enthusiastic about the prospects of developing a microbicide.
在8月举行的16届国际艾滋病会议上，Bill和Melinda Gates表示他们非常看好开发一种抗生素的前景。
Wednesday, Dr. Nicholas Hellmann, acting director of the foundation's H.I.V. and tuberculosis program, affirmed the optimism.
在星期三，该基金会H.I.V.和结核病计划的临时主管Nicholas Hellmann对其前景表示乐观。
"We remain hopeful that a safe and effective microbicide will be developed," Hellmann said, adding that the foundation was still committed to supporting research on microbicides and other prevention methods.
“我们仍然希望可以生产出一种安全、有效的抗生素，” Hellmann说，并且补充说他们的基金会保证继续支持抗生素的研究和其他预防办法。
The new findings were surprising, researchers said, because 11 smaller trials of more than 500 women conducted since 1999 showed that cellulose sulfate was safe. The chemical, which was developed as Ushercell by Polydex Pharmaceuticals in Toronto, was active against H.I.V. in laboratory tests.
研究人员说，新的发现结果令人吃惊，因为从1999年以来，超过500名女性参加的11个小型试验表明纤维素硫酸盐是安全的。这种由多伦多的Polydex制药厂研制的Ushercell，在试验室检验中可以有效地抑制H.I.V.。
Dr. Peter Piot, the executive director of Unaids in Geneva, said the new findings were puzzling because there appeared to be no biological explanation for the failure of cellulose sulfate, as there was in the case of nonoxynol-9 and the ulcers associated with its use.
日内瓦Unaids的执行主管-- Peter Piot博士说，新的发现结果让人莫名其妙，因为对于纤维素硫酸盐的失败没有生物学方面的解释，就和nonoxynol-9的情况一样，溃疡的发生与其使用有关。
Finding new drugs like a microbicide often can be a process of trial and error, and requires scientifically rigorous trials, Piot said.
发现类似抗生素的新药常常需要反复试验，而且必须进行科学、严密的试验，Piot说。
He speculated that one of the antiretroviral drugs used to treat AIDS might be needed for an effective microbicide. The world needs a microbicide because "the stakes are so high," Piot said.
他推测，一种过去常用于治疗AIDS的抗病毒药可能需要辅助使用一种有效的抗生素。Piot说，这个世界需要一种抗生素，因为“奖金是如此之高”。
http://www.iht.com/articles/2007/02/01/healthscience/web.0201aids.php

编译：
字数：1364
iht.com最新报道：
标题：阻断HIV传染药物实验因安全问题而被叫停
日期：2007年2月1日
正文：一种用以预防性生活中H.I.V.感染的局部抗生素，在星期三遇到了巨大挫折，研究人员宣布因为安全原因他们已经全面停止了试验。
在非洲和印度进行的这些试验涉及到一种化学药品—硫酸盐性纤维素或Ushercell，这是近年来一种可能的抗生素在进行全面试验时遇到的第二次失败。根据独立科学委员会的检验标准，在最近的一个试验中，使用硫酸盐纤维素的女性比使用胶状安慰剂的女性感染 H.I.V的风险增加。
在2000年，一个大规模的全面试验显示，只有另外一种抗生素 nonoxynol-9与预期效果不同，其存在安全问题。在那个试验中的受试者感染H.I.V.的风险更高，推测可能是通过化学刺激性溃疡引起。
在星期三，世界卫生组织、联合国AIDS计划组和其他组织表示，三种其他进行过全面检验的可能抗生素中，至少有一种证明是安全、有效的。其他的包括Indevus制药厂生产的磺酸萘聚合物，ReProtect和Carraguard生产的BufferGel，其商标权由人口委员会掌握。
“这些试验的停止令抗生素领域十分失望，但我们不能让这使我们陷入困境”，Silver Spring, Md的非营利性国际抗生素合作组织的首席执行官Zeda Rosenberg博士说。
由于缺乏一种AIDS疫苗，专家称发展一种抗生素首先考虑的是公共健康，主要为了保护那些贫穷国家其伴侣拒绝使用安全套的众多女性。这种保护可以采用能够插入阴道或直肠的凝胶状物，乳剂，薄膜，片剂或海绵状物。
导致这些试验停止的研究涉及到Benin，南非和乌干达的1333名参与者，由Arlington, Va的一个健康研究组织- Conrad进行该研究。Conrad称独立委员会发现，那些使用硫酸盐纤维素的女性比使用惰性凝胶的女性感染新的H.I.V.的数量要多，但是他们没有透露具体数字。Conrad的一个发言人说最后的数字预期在3月公布。
但是，家庭保健国际研究组织--Triangle Park, N.C.在尼日利亚进行了包括1700参与者的第二次试验。该研究发现，其既对预防H.I.V.没有帮助，但也不会增加H.I.V.的发生风险。因此，如果在Conrad的试验中得到了不利的发现结果，“负责任的做法就是停止我们的研究”，该试验的主要负责人家庭保健国际研究组织的Vera Halpern博士也说。
一个理想的抗生素应该在三个方面起作用。第一，它可以杀死阴道和子宫颈里面的H.I.V.；第二，这种抗生素可以阻止任何从黏附在女性细胞内逃脱出来的病毒（这种病毒就是通过此方式发动感染）；第三，对于任何进入细胞的病毒来说，抗生素可以阻断一种病毒赖以复制的逆转录酶。
Bill和Melinda Gates基金会以及国际发展委员会为这两个最新的研究提供了2000万美元的资助。在8月举行的16届国际艾滋病会议上，Bill和Melinda Gates表示他们非常看好开发一种抗生素的前景。在星期三，该基金会H.I.V.和结核病计划的临时主管Nicholas Hellmann对其前景表示乐观。“我们仍然希望可以生产出一种安全、有效的抗生素，” Hellmann说，并且补充说他们的基金会保证继续支持抗生素的研究和其他预防办法。
研究人员说，新的发现结果令人吃惊，因为从1999年以来，超过500名女性参加的11个小型试验表明纤维素硫酸盐是安全的。这种由多伦多的Polydex制药厂研制的Ushercell，在试验室检验中可以有效地抑制H.I.V.。日内瓦Unaids的执行主管-- Peter Piot博士说，新的发现结果让人莫名其妙，因为对于纤维素硫酸盐的失败没有生物学方面的解释，就和nonoxynol-9的情况一样，溃疡的发生与其使用有关。
Piot说，发现类似抗生素的新药常常需要反复试验，而且必须进行科学、严密的试验。他推测，一种过去常用于治疗AIDS的抗病毒药可能需要辅助使用一种有效的抗生素。他说，这个世界需要一种抗生素，因为“对其资助非常之高”。
http://www.iht.com/articles/2007/02/01/healthscience/web.0201aids.php

2007-02-07 13:44

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我想知道，阴道里的 PH值对HIV的感染有没有预防作用？

2007-02-07 23:27

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