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Another HIV microbicide a bust

Another microbicide to prevent linkurl:HIV;http://www.the-scientist.com/article/display/23586/ transmission has been deemed ineffective. The Population Council, a nonprofit research organization, which has been developing the microbicide Carraguard, announced today that phase III clinical results show it ineffective in linkurl:preventing HIV;http://www.the-scientist.com/article/daily/53516/ transmission. The trial, which ended in March of last year, involved 6,202 women and cost around $40 mil

By | February 18, 2008

Another microbicide to prevent linkurl:HIV;http://www.the-scientist.com/article/display/23586/ transmission has been deemed ineffective. The Population Council, a nonprofit research organization, which has been developing the microbicide Carraguard, announced today that phase III clinical results show it ineffective in linkurl:preventing HIV;http://www.the-scientist.com/article/daily/53516/ transmission. The trial, which ended in March of last year, involved 6,202 women and cost around $40 million. Of the 3,103 participants who were using the microbicide gel, 134 became infected with the virus while on the trial, as opposed to 151 out of 3,099 who were using a placebo. These results are not statistically significant, Khatija Ahmed, from the University of Limpopo in South Africa, and principal investigator of the trial, said in a telephone press conference last Thursday (February 14). Microbicides to prevent HIV have had a rough ride on the path to development, and there are currently none approved for use as anti-HIV agents. linkurl:Last year,;http://www.the-scientist.com/news/display/52861/ the phase III clinical trial for an anti-HIV microbicide called Ushercell was halted when initial data suggested that it increased the risk for infection. Carraguard is a clear gel that, when applied to the vagina, is supposed to block pathogens from reaching epithelium cells. But the Carraguard results won't put an end to microbicide development, Robin Maguire, director of microbicides product development at the Population Council's Center for Biomedical Research, said during the press conference call. "We will be developing the next generation of products using Carraguard; this study did demonstrate its safety," she said. In particular, the organization is hoping to start a phase I clinical trial this year of a microbicide that is a combination of Carraguard and an antiretroviral, MIV-150. In vitro testing has shown the antiretroviral to be more stable in the Carraguard gel than an inert gel. Of all participants who enrolled in the trial about 69% completed it in full, and only about 10% used the gel 100% of the time. Researchers are continuing to analyze these results to determine if low adherence might have played into the efficacy results.
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Comments

Avatar of: Fukai Bao

Fukai Bao

Posts: 15

February 18, 2008

This a key question.
Avatar of: anonymous poster

anonymous poster

Posts: 1

February 18, 2008

I am taken aback that this study design was permitted. I doubt it would be approved in the U.S. An experimental design using a placebo likely gives women a false sense of security and may greatly affect the decision to have unprotected sex. I also can't belive 285 women contracted HIV before the study was halted.
Avatar of: anonymous poster

anonymous poster

Posts: 26

February 18, 2008

The last paragraph of this article should have been near the top. Or perhaps the title should have been, "Clinical Trial invalid since 90% of participants refused to follow protocol." It won't matter how many anti-virals they add to their gel if people are unwilling to use it "religiously".\n\nBaxter Zappa
Avatar of: Yaa Simpson

Yaa Simpson

Posts: 2

February 19, 2008

Greetings,\nI am glad to see efforts to develop an effective microbicide is continually being pursued. However, I also question the study design, not only with adherence issues, but the fact that women were exposed without any other measures of protection. Is this an ethical issue for a study to allow natural risk vs. possibly a false sense of protection? Based on the numbers it seams that the HIV positivity rate for 6,202 women was about 4.5%. That appears to be relatively high as compared to the less than 3% HIV positivity rate for various U.S. sites. \nI would encourage the protocol team to reconsider including U.S. sites as well. I am no longer comfortable with doing trials in other countries without including U.S. sites. It is unethical and members of community advisory boards should not allow for this to happen again. \nSista Yaa, Community Epidemiologist for\nThe Association of Clinical Trials (TACTS)\n
Avatar of: anonymous poster

anonymous poster

Posts: 1

February 19, 2008

This reminds me of the Non-oxynol 9 trial. A spermacide that was supposed to help prevent AIDS, (also used on 3rd world women) Instead it actually increased the chances of AIDS with the minute tears (much like asbesto cuts) So what did they do but bring it to the USA and gave it out to the 'free' clinics. It's in spermacides and many lubricated condoms, and many women suffered the effects of it's burning and severe irritation to the genitals. *sigh* \n
Avatar of: anonymous poster

anonymous poster

Posts: 6

February 20, 2008

I suspect this study was done on women in the "sex trades". It's well known that condom use, while rising, is not well regarded within these trades because the "customer base" doesn't like it. So, in this case, is it unethical? For people who are likely not to use the known effective methods, is it ok to suggest this method and record the results. \n\nI agree, it feels wrong, but was there an alternative?
Avatar of: anonymous poster

anonymous poster

Posts: 1

February 24, 2008

People, get your facts straight and understand what's really going on before you mouth off! This was some incredibly well-intentioned, carefully done, commendable, ethically caring, and as scientifically rigorous as possible given the challenges work. I say that as someone who has no vested interest or involvement in the work but was a close observer and visited the clinical trial sites during the course of the study. If you think you can do better, get off your computer chairs, stop mouthing off in an uninformed way, and do something about the 1 million new HIV infections among people globally every year.
Avatar of: steve clark

steve clark

Posts: 3

February 24, 2008

To the folks worried about different aspects of ethical design of this study, I recommend caution. This short article does not provide enough information to evaluate the ethics of the trial design. While attention to proper design is commendable, jumping to conclusions can affect the ability of such trials to continue. Please check the full publication for study details and then make specific points regarding study design. Specific criticism is very helpful, generalizations are harmful to the conduct of clinical trials. Thanks.

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