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US experts urge approval of first AIDS prevention pill

Posted on 11. May, 2012 by in HIV/AIDS, HIV/AIDS Global News

by Agence France-Presse

WASHINGTON (AFP) – US health advisers on Thursday urged regulators to approve Truvada, made by Gilead Sciences, as the first preventive pill against HIV/AIDS instead of just a treatment for infected people.

The favorable vote came after clinical trials showed Truvada could lower the risk of HIV in gay men by 44% to 73%, and was hailed by some AIDS advocates as a potent new tool against human immunodeficiency virus.

However, many concerns were raised during a marathon 11-hour panel meeting in which about three dozen health care providers warned that the pill could boost risky behaviors and possibly lead to a drug-resistant strain of HIV.

The Food and Drug Administration is not bound by the recommendations of its expert panel, but usually follows the advice. A final decision by the FDA is expected by June 15.

Mitchell Warren, executive director of HIV prevention group AVAC, said after the vote that pre-exposure prophylaxis (PrEP), or the method of taking a drug ahead of potential exposure to HIV, “while not a panacea, will be an essential additional part to the world’s success in ending AIDS.”

“For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope,” he added.

The drug, made by the California-based Gilead Sciences, is currently available as a treatment for people with HIV in combination with other anti-retroviral drugs, and received FDA approval in 2004.

The panel’s nod came in response to the pharmaceutical company’s request for a supplemental new drug application to market it for prevention purposes.

The Antiviral Drugs Advisory Committee voted for the drug as a preventive measure for three groups: 19-3 in favor for men who have sex with men, 19-2 with one abstention for couples in which a partner is HIV positive and 12-8 with two abstentions for other at-risk groups.

Gay men account for more than half of the 56,000 new HIV cases in the United States each year, according to the Centers for Disease Control and Prevention (CDC).

But critics noted that the pill is costly — up to $14,000 per year — and could offer a false sense of protection, leading to a spike in unsafe sex and a new surge in AIDS cases.

“We need to slow down. I care too much about my community not to speak my concerns,” said Joey Terrill, advocacy manager at the AIDS Healthcare Foundation, which campaigned against the drug’s approval for PrEP.

There also remains some controversy about who would benefit from the treatment, as trials in women have shown feeble results, possibly due to poor adherence to the regimen.

“I am concerned about the potential for development of resistance,” said Roxanne Cox-Iyamu, a doctor who spoke at the panel’s meeting.

“I am concerned as a black woman that we don’t have enough data that this actually works in women.”

Nurse Karen Haughey said Truvada will not work because “it is not in our nature to always do as human beings what we are told 100 percent of the time.”

She also said Truvada’s main side effects — diarrhea and risk of kidney failure — were a major deterrent.

The main set of data considered came from the iPrEx HIV Prevention Study, carried out from July 2007 to December 2009 in six countries — Brazil, Ecuador, Peru, South Africa, Thailand and the United States.

The study was conducted among 2,499 men who were sexually active with other men but were not infected with the virus that causes AIDS.

Participants were selected at random to take a daily dose of Truvada — a combination of 200 milligrams of emtricitabine and 300 milligrams of tenofovir disoproxil fumarate — or a placebo.

Those in the study who took the drug regularly had almost 73 percent fewer infections. Across the entire study, including those who had not been as diligent in taking Truvada, there were 44 percent fewer infections than in those who took a placebo.

After publication in 2010 in the New England Journal of Medicine, some experts hailed the results as game-changing and the first demonstration that an already-approved oral drug could decrease the likelihood of HIV infections.

Joseph McGowan, medical director of the Center for AIDS Research and Treatment at North Shore University Hospital in New York, said the CDC was expected to soon issue guidance for health professionals who may prescribe the drug.

“I don’t see it as something that would be useful to the general public but to certain people who are particularly high risk, there may be some benefit,” he said. - Agence France-Presse

 

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Sex in Switzerland: How the Swiss Do It

Posted on 05. Aug, 2011 by in HIV/AIDS Global News, Safe (Sensible) Sex

Sex in Switzerland: How the Swiss Do It

By Ana Santos

SWITZERLAND — On a recent trip to Switzerland, I stayed at a friend’s apartment which was a welcome respite from having to stay in another box of a hotel room.  It also allowed me another benefit:  watching “regular” TV and not being limited to channels that are pre-screened by the hotel.

I was pleasantly shocked by what I saw on TV, almost continuously.
In the middle of the afternoon (maybe even in the morning), there was all this sex and nudity on TV.

And I’m not even talking about the subtle stuff we normally see: the slow music (usually from horn instruments), kissing, exposed neck and shoulders rubbing together and then–before we get too excited–zoom out!  Everything else is left to the imagination.

I think the most daring scenes I ever saw was Miranda revealing one boob to her neighbor and Charlotte showing one boob to an overzealous sailor during Fleet Week, but in Switzerland, they were at it in broad daylight, in the middle of the day, on regular cable TV (not pay per view) going at like bunnies, and in such splendor, and at times, with much bravado.

There was sound–oh, was there sound! There was certainly no absence of grunts, moans and heavy breathing.  There were various positions, some even acrobatic, and to complete the whole caboodle– there was nudity. Yes, boys and girls, only genitalia remained hidden.

May be I shouldn’t have been shocked to see such things in Switzerland. This was after all the sight that greeted me at the bathroom of the Geneva  Airport.

Vending machine for condoms and tampons. One pack costs CHF1, roughly around Php50.

Condoms and tampons at your disposal

Isn’t that such a kind reminder to have a “safe” trip? : )

In the souvenir shops, there were stuffed vibrators for sale and just about every usual souvenir from cups, mugs to calendars was decorated with explicitly sexy illustrations.

Stuffed vibrators that pledge monogamy: “I vibrate only for you.” And yes, they do actually vibrate.

With sex being so omnipresent, just oh, so casual, I felt compelled to research more on the sexual attitudes and behaviors of the Swiss—the nation that is known for being neutral (Swiss history), precise (Swiss watches) and calculating (Swiss banks).

Here are some interesting discoveries:

DRIVE-IN SEX BOXES:

In Zurich, where prostitution continues to be a major problem, sex-boxes have been installed by authorities so that sex workers and their clients can do business discretely hidden from the public eye. A statement issued the police read: “We can’t beat or stop prostitution, but can try to control it.”

SWISS KIDDIE-SIZED CONDOMS

Hotshot Condoms have been created specifically for 12-14 year old boys.  Hotshot costs about (£4.70 ) for a pack of 6 and were produced after government research showed that more 12-14 years olds were having sex compared with the 90s, but were not using sufficient protection when having sex.The study, conducted on behalf of the Federal Commission for Children and Youth, interviewed 1,480 people aged 10 to 20 and found that the average condoms on sale were often too big for these boys, leaving them and their partners, at risk for unwanted pregnancy or sexually transmitted infection.

Hotshot Condoms are produced by Lamprecht AG, a leading condom manufacturer in Switzerland.

SWITZERLAND IS NAMED ONE OF THE 10 PLACES IN THE WORLD TO HAVE SEX IN 2011

Offtrack.com names The Swiss Chocolate Train as one of its “major panty droppers” for this year.  In your chocolate-induced friskiness, you can ahem, ride the Swiss Chocolate Train from the Swiss town of Montreux to Guyeres for just USD22.

SWISS LUBE

They not only have knives, banks and chocolates branded as “Swiss”, they also have lubricant.  Swiss Navy Lubricant boasts of being the Rolls Royce of lubrications with a “more natural touch and feel–like you are not using any lubrication at all.”

It even has a patented leak proof bottle design with single hand pump for easy one-hand application. They’ve thought of just about everything, haven’t they?

Of course, being the SASsy girl that I am, I had to check out the related teen pregnancy rates and incidence of HIV and AIDS.

SEX EDUCATION STARTS YOUNG

In Switzerland, age of consentis 16 and mandatory sex education is taught in school starting age 10. There is easy and inexpensive, if not free, access to safer sex information and services for the youth.

SWITZERLAND HAS THE LOWEST TEEN PREGNANCY RATE IN WESTERN EUROPE AND ONE OF THE WORLD’S LOWEST RATES OF ABORTION

Guttmacher Institute published a study in 1993 as part of the Swiss Multicentre Adolescent Survey on Health, 5% of 1,726 sexually active adolescents (15-20 years old) in a group of 3,993 had ever been pregnant. This study confirmed Switzerland as having the lowest adolescent fertility rate in Western Europe.

A 2006 article in the Washington Post, which quotes a Swiss healthcare practitioner reaffirms this.

According to Pierre-Andre Michaud, chief of the Multidisciplinary Unit for Adolescent Health at the University of Lausanne Hospital in Switzerland, “Switzerland has one of the world’s lowest rates of abortion and teen pregnancy.”

The article goes on to say:

A 2001 Guttmacher Institute report, drawing on data from 30 countries in Western and Eastern Europe, concluded: “Societal acceptance of sexual activity among young people, combined with comprehensive and balanced information about sexuality and clear expectations about commitment and prevention childbearing and STDs [sexually transmitted diseases] within teenage relationships, are hallmarks of countries with low levels of adolescent pregnancy, childbearing and STDs.” The study cited Sweden as the “clearest of the case-study countries in viewing sexuality among young people as natural and good.”

HIV INCIDENCE IS LOW

According to 2009 data available on Avert.org. Switzerland has a 0.4% adult HIV prevalencerate.  In terms of actual number, this is estimates about 18,000 people living with HIV.Here’s a snapshot of the HIV and AIDS in Switzerland according to the Swiss AIDS Federation:

  • In Switzerland there are currently about 25,000 people living with HIV and Aids
  • From the start of the epidemic to the end of December 2009, more than 9000 cases of Aids have been notified. Nearly 6000 people have died of the consequences of Aids.
  • In 2010, 609 new positive HIV test results were notified. Of these, 25% were women.
  • Approx. 44% of all infections are due to heterosexual contacts

To put this in perspective and to compare it to the Philippines:

Switzerland

Philippines

HIV Incidence

25,000

7,031

Population

7.6 million

92 million

Source for HIV incidence in the Philippines: DOH HIV Registry as of June 2011 
In terms of number, Switzerland may have four times more PLHIV, but their population is 10 times less than ours.

This led me to conclude either one of two things. One, may be the Swiss are so open about talking about sex more and therefore have less time to have it. Or two, sex was just made so available, that after awhile, it was like my reaction to seeing yet another couple on top of one another on daytime TV. I simply said, almost exasperated, “Again?!” and just changed the channel to watch something else.

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UNAIDS and WHO report breakthrough in HIV prevention

Posted on 14. Jul, 2011 by in HIV/AIDS, HIV/AIDS Global News

PRESS RELEASE
UNAIDS
13 July 2011 l Geneva

 

The results and data from studies in Kenya, Uganda and Botswana disclose that a daily antiretroviral tablet taken by people without HIV infection can reduce their risk of acquiring HIV by up to 73%. Both daily tenofovir and daily tenofovir/ emtricitabine taken as preventive medicine can avert heterosexual transmission of HIV from men to women, and vice versa.

“This is a major scientific breakthrough which re-confirms the essential role that antiretroviral medicine has to play in the AIDS response,” said Michel Sidibé, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS).

Read the full story: http://www.unicmanila.org/main/index.php?pg=news&id=577

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U.N. to Look at Discriminatory AIDS Laws

Posted on 01. Aug, 2010 by in HIV/AIDS, HIV/AIDS Global News

U.N. to Look at Discriminatory AIDS Laws

View original article on the hivplusmag website here.

A newly formed United Nations commission will investigate laws across the globe that discriminate against HIV-positive individuals, the agency has announced. 

“Laws that inappropriately criminalize HIV transmission or exposure can discourage people from getting tested for HIV or revealing their HIV-positive status,” said a joint statement from the U.N. Development Program and the Joint United Nations Programme on HIV/AIDS. Experts on the Global Commission on HIV and the Law are drawn from the fields of law, public health, human rights, and HIV. They are charged with developing recommendations by December 2011 on how laws can advance universal access to HIV prevention, treatment, and care. 

The effort is intended to help “restore the dignity of people and to remove the bad rules,” UNAIDS chief Michel Sidibe said. 

Some 49 countries criminalize transmission or exposure to HIV, and 86 countries have legislation antagonistic to gay people, including seven that impose the death penalty for homosexuality, Sidibe said. 

An estimated 52 nations restrict the travel of people with AIDS. Other laws pose challenges to proper care for drug users, the agencies noted. 

“Laws that criminalize men who have sex with men, transgender people, drug users, and sex workers can make it difficult to provide essential HIV prevention or treatment services to people at high risk of infection,” the joint statement said.

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Will you play with yourself tonight?

Posted on 08. Jul, 2010 by in HIV/AIDS, HIV/AIDS Global News, Safe (Sensible) Sex

Will you play with yourself tonight?

Good. Safe. Sex.

That’s what we want more of.  Right ?

That’s what we are all about at The Pleasure Project. We think you can’t have safe sex unless you know how to have good sex.

But we are sad. . . . . . . .  that the world of sex education and HIV prevention does not seem that interested in pleasure or desire. And we are trying to change that.

This week at the world AIDS conference being held in Vienna we are spreading the word. And that’s why I am really excited to be a guest bloggers for Ana’s site – and tell you all about it.

This is me

http://thepleasureproject.org/wordpress/author/anne/

I love SexAndSensibilities.com as it is an exact illustration of how more of the public health and sex education world should be highlighting safer sex. Between 5% and 13% of websites are pornographic – and at last count 27% of the world had access to the internet – and 20% in Asia. The old tired methods of school sex education and pamphlets is just not going to cut the mustard anymore – when people want to know about sex and how to make it safe.

So we are trying to spread the word this week in Vienna with the 25,000 participants at the AIDS conference – AIDS 2010. We are hoping to get them talking about what they get up to at conferences – rather than talking only about their research into what others get up to. And showing how sharing fantasies is good.safe.sex. And we know that those big international gatherings are a potential hot bed of fantasies, especially when you are talking about sex ALL day. . . .

This is our poster campaign starting to be put up in the conference halls in Vienna this morning. . . .

And this is our campaign. Please send us a conference fantasy ….or any fantasy.


Sex at the AIDS Conference

See the Fantasies Our Blog What We Do

We believe that you can have safer sex if you know how to have good sex. Globally, HIV is primarily a sexually transmitted epidemic. Yet, at international events like the AIDS conference, it is rare to hear sex being discussed. If we are going to really address the HIV epidemic, we will need to address sexuality directly, and promote realistic safer sex options.

Fantasizing – day dreams, erotica, pornography – is a form of sexual expression that carries absolutely no risk of HIV transmission. So come on! Share your AIDS2010 fantasy and make the conference a safer, sexier place.

Read, post, and share your AIDS2010 fantasies on our blog.
You can also be a voyeur on facebook. If you want to hear what we’re up to about four times a year, sign up for our mailing list.

The Pleasure Project makes safe sex safer and sexier.

We advocate for the importance of pleasure in sexual health, by training health professionals and educators about making safer sex sexy. We are also working on building the evidence base around pleasure and safer sex, and we do condom consultancies for the erotic media.

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Vaginal ring brings new hope for HIV prevention

Posted on 10. Jun, 2010 by in HIV/AIDS Global News, Women Deliver 2010

Washington, D.C., June 9, 2010 — A vaginal ring containing an anti-retroviral drug is currently undergoing safety and acceptability testing as a tool to prevent HIV transmission during sex. This was the announcement made today by health officials at the Women Deliver 2010 Conference in Washington, D.C.

The clinical trial known as IPM015 tests the safety and the acceptability of a vaginal ring which contains the ARV dapivirine as its active ingredient. Once inserted into the body, the silicone ring will slowly release dapivirine and provide protection against HIV for 28 days.

Dr. Zeda Rosenberg, Chief Executive Officer of International Partnership for Microbicides, the non-profit organization which makes the vaginal rings, says, “We took the vaginal ring and added an ARV component which gives it a protective element against HIV.”

“There have been well-documented cases of health care workers who have had needle prick exposures to HIV and were given a round of ARV to protect them from HIV infection.”, says Rosenberg, explaining the concept of the ring.

ARVs have been proven potent in prolonging and improving the quality of life of those living with HIV as well as reducing mother-to-child transmission of HIV.

 

Safety first

IPM 015 will test among 280 HIV negative women across Africa. Recruitment for the study has already started in South Africa, while clearance for testing in another 4-5 countries in Africa is in the works.

If proven successful with this first batch of testing, efficacy testing will be done.

“It is an intensive safety study that studies local, vaginal and systemic safety.” explains Rosenberg. Other subjective measures such as appeal to the end user on the basis of non- irritation and ease of insertion are also going to be tested.

“We have to make sure that we are first not going to cause any harm. Because when a woman says that it itches or burns, it is not going anywhere.”

Initial test results though showed hope for the efficacy.

“There were some concerns about the drug distributing itself well into the vagina.  We’re very happy that initial tests showed that the dapivirine distributed itself well into the vagina and migrated to the vaginal tissue. And that’s what it’s all about when it comes to microbicides – the right drug, the right place and the right time.” says Rosenberg.

If this initial testing proves successful, the next stage will be large scale efficacy testing in 2011.

Vaginal rings are already being used in developed countries for birth control and hormonal replacement therapy for menopause.

While IPM 015 does not act as a contraceptive, they are highly appealing because they are self-administered, discreet and provide protection from HIV for a month or more.

 

Bringing together protection and prevention

“We cannot reverse maternal deaths or fully ensure the health of women and girls without stopping the spread of STIs, which are preventable and avoidable. This marks the bringing together for the reproductive health protection and STI prevention.” said Jill Sheffield, President of Women Deliver.

Elizabeth Mataka, UN Secretary General’s Special Envoy for AIDS in Africa also welcomed this innovation in vaginal rings. “I come from a country which is the epicenter of HIV. Everyday there are 3,000 girls around the world who become infected with HIV. This vaginal ring will provide women with a reproductive health tool that can be used discreetly. They will not need the expressed consent from their partner.”

Approval of the vaginal ring by a regulatory body is targeted for 2015.

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The Lazarus Effect: How 40 cents can improve the lives of those living with HIV/AIDS

Posted on 09. May, 2010 by in HIV/AIDS, HIV/AIDS Global News

U2’s Bono, Penelope Cruz, Julian Moore and Benicio del Toro are among the famous faces featured in  THE LAZARUS EFFECT, a public service announcement campaign to raise awareness about the transformative effect of antiretroviral therapy (ART) on people living with HIV and AIDS in Africa. The initiative is the work of The Global Fund and (PRODUCT) REDTM.

THE LAZARUS EFFECT highlights the impact of this life-saving therapy on people living with HIV, whose lives have been transformed from debilitating  illness to a healthier, more stable life in as little as three months.  It shows how two antiretroviral pills a day that cost around 40 cents can reverse the devastating impact of HIV, bringing renewed hope and opportunity. The campaign conveys the power of 40 cents by comparing items costing this amount, such as a stick of gum or a smear of lipstick to the value of one day’s worth of antiretroviral medication.  

Other celebrities featured in the campaign are Naomi Watts, Claire Danes, Alek Wek, Iman, John Turturro, Toni Collette, Hugh Jackman, Orlando Bloom, Lucy Liu, Gabourey Sidibe, Kerry Washington, Bryan Cranston, LeAnn Rimes, Jane Lynch, Michelle Rodriguez, Gwen Stefani, Hayden Christensen, Julia Louis-Dreyfus, Don Cheadle, Ludacris, Common, Dakota Fanning, Christy Turlington and the Jonas Brothers.

The Global Fund provides about one fifth of international funding for the response to HIV. The Global Fund finances among other things antiretroviral for 50 percent of the people who currently access this lifesaving treatment in Africa.  “Access to AIDS treatment is absolutely critical to reduce the enormous social and economic impact of HIV/AIDS on households, communities, businesses and national economies,” said Professor Michel Kazatchkine, Executive Director of the Global Fund.  “By supporting the most vulnerable populations affected by HIV through access to essential and affordable medicines, we can provide a life-line to improved health and help people build better futures for themselves, their families and their communities,” he added.

The Philippines is one of the countries that receives aid from The Global Fund allowing those living with HIV/AIDS to receive their ARV treatment for free. ARV Treatment is estimdated to cost at least Php30,000 per month.

Important progress has been achieved in preventing new HIV infections and in lowering the annual number of AIDS-related deaths. However, the number of people living with HIV/AIDS is still rising. By the end of 2008, 33.4 million people worldwide were living with HIV/AIDS, 22.4 million of them in sub-Saharan Africa.  The same year, more than 14.1 million children in sub-Saharan Africa were estimated to have lost one or both parents to AIDS.
 
Expanded access to aids treatment has been the main cause of a decline in AIDS-related deaths in recent years, with more than 4 million people accessing the medication worldwide by the end of 2008 – a significant increase from 2001 when virtually no-one with HIV was receiving antiretroviral therapy in developing countries.  However, out of a total of 9.5 million people in developing and transitional countries in immediate need of life-saving HIV drugs, this reflects access for only 42% of those in urgent need.
 
For more information on THE LAZARUS EFFECT, visit WWW.JOINRED.COM or view THE LAZARUS EFFECT videos on http://www.youtube.com/joinred.

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Women who are married or in long-term relationships also at risk for HIV

Posted on 31. Jan, 2010 by in HIV/AIDS, HIV/AIDS Global News, Sex & Relationships

Women who are married or in long-term relationships also at risk for HIV
An estimated 50 million women in Asia are at risk of contracting HIV from male partners who engage in risky sexual behaviours, says a new UNAIDS report released at the 9th International Congress on AIDS in Asia and the Pacific (ICAAP) in Bali, Indonesia last August. Continue Reading →
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The feminization of HIV

Posted on 25. Jan, 2010 by in Global News, HIV/AIDS, HIV/AIDS Global News

Women are most at risk for HIV/AIDS.

Statistics show that globally, HIV/AIDS is the leading cause of death and disease in women of reproductive age. Continue Reading →

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AIDS Vaccine one of 2009′s best inventions

Posted on 24. Jan, 2010 by in HIV/AIDS, HIV/AIDS Global News, Safe (Sensible) Sex

AIDS Vaccine one of 2009′s best inventions

The AIDS vaccine is named one of the 50 Best Inventions of the Year by Time Magazine in the November 2009 issue

A vaccine is not exactly a novel invention, but one that’s designed to fight HIV certainly is. More than 20 years after the AIDS virus was identified, researchers have devised the first immunization to protect people against HIV infection. A six-year-trial showed that the vaccine, which consists of two shots that given individually had failed to protect against HIV, is modestly effective, reducing infection by 31% among those receiving the regimen vs. those getting a placebo. Scientists are still trying to figure out how the vaccine decreases infection risk, since the shots did not affect the level of the virus in the blood of volunteers. And some experts question whether the small effect is indeed significant. The vaccine is not approved for use yet, but it’s the first to make any headway against HIV, and that’s a start.

– SAS attributes this post to  Time Magazine

Filipino scientist involved in HIV-vaccine research

Marni Eusebio Cueno, a graduate of Biology with a major in Genetics as well as a Master of Science degree in Molecular Biology and Biotechnology from the University of the Philippiines in Los Baños (UPLB), together with Japanese scientists, is conducting research in developing HIV-edible vaccine using tomatoes.

The research project, started by Takashi Okamoto M.D., PH. D., and Antonio C. Laurena, PhD., is a joint effort between the Department of Molecular and Cellular Biology, Nagoya City University Graduate School of Medical Sciences in Japan and UPLB’s Bioechemistry Laboratory Institute of Plant Breeding.

In July 2009, it was reported that the research team was able to produce humoral (antibody production) and cellular (cytotoxic T lymphocytes production) immune responses in mice that were injected with the experimental vaccine. The group has also shown that a gene from a human virus such as HIV-1 Tat can also affect a plant when transiently expressed. “Our results, thus, further support the idea of producing potential HIV-1 vaccine in plants,” Cueno explained.

“The main feature of this AIDS vaccine which I am trying to develop is that it would be produced in plants, making it less expensive than commercially available vaccines,” says Cueno.

Read more about Marni Eusebio Cueno and HIV-Vaccine research on:

http://www.abs-cbnnews.com/07/28/09/pinoy-scientist-global-search-aids-vaccine

Information also available on:

IRIN Plus News

http://www.irinnews.org/Report.aspx?ReportId=86279

International AIDS Vaccine Initiative

http://www.iavi.org/Pages/home.aspx

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