3 big developments make AIDS outlook more hopeful

24 nov 2010-- In the nearly 30 years the AIDS epidemic has raged, there has never been a more hopeful day than this. Three striking developments took place Tuesday: U.N. officials said new HIV cases are dropping dramatically worldwide. A study showed that a daily pill already on pharmacy shelves could help prevent new infections in gay men. And the pope opened the way for the use of condoms to prevent AIDS.

"I don't know of a day where so many pieces are beginning to align for HIV prevention and treatment, and frankly with a view to ending the epidemic," said Mitchell Warren, head of the AIDS Vaccine Advocacy Coalition, a nonprofit group that works on HIV prevention research. "This is an incredibly opportune moment and we have to be sure we seize it."

President Barack Obama said the groundbreaking research on the AIDS drug "could mark the beginning of a new era in HIV prevention."

The U.N. report said that new cases dropped nearly 20 percent over the last decade and that 33.3 million people are living with HIV now.

"We can say with confidence and conviction that we have broken the trajectory of the AIDS pandemic," said UNAIDS Executive Director Michel Sidibe in Geneva.

Health officials credit part of the decline to wider condom use, and on Tuesday, in a historic shift in church teachings, the Vatican said that using a condom is a lesser evil than infecting a sexual partner with HIV.

Condoms remain the best weapon against AIDS, and the new prevention pill is not the chemical equivalent. But scientists called it a true breakthrough. The pill, Gilead Science's Truvada, is already used to treat people with HIV. A three-year global study found that daily doses cut the risk of infection in healthy gay and bisexual men when given with condoms, counseling and other prevention services.

The drug lowered the chances of infection by 44 percent, and by 73 percent or more among men who took their pills most faithfully. Researchers had feared the pills might give a false sense of security and make men less likely to use condoms or to limit their partners, but the opposite happened - risky sex declined.

The results are "a major advance" that can help curb the epidemic in gay men, said Dr. Kevin Fenton, AIDS prevention chief at the U.S. Centers for Disease Control and Prevention. But he warned they may not apply to people exposed to HIV through male-female sex, drug use or other ways. Studies in those groups are under way.

Because Truvada is already on the market, the CDC is rushing to develop guidelines for doctors who want to use it to prevent HIV, and urged people to wait until those are ready.

As a practical matter, price could limit use. The pills cost $5,000 to $14,000 a year in the United States, but roughly $140 a year in some poor countries where they are sold in generic form.

Whether insurers or government health programs should pay for them is one of the tough issues to be sorted out, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

"This is an exciting finding," but it "is only one study in one specific study population," so its impact on others is unknown, Fauci said.

His institute sponsored the study with the Bill & Melinda Gates Foundation. The findings were published online by the New England Journal of Medicine.

It is the third AIDS prevention victory in about a year. In September 2009, scientists announced that a vaccine they are now trying to improve protected 1 in 3 people from getting HIV in a study in Thailand. In July, research in South Africa showed that a vaginal gel spiked with an AIDS drug could cut nearly in half a woman's chances of getting HIV from an infected partner.

Gay and bisexual men account for nearly half of the more than 1 million Americans living with HIV. Worldwide, more than 7,000 new infections occur each day. Only 5 to 10 percent of global cases involve sex between men.

"The condom is still the first line of defense," because it also prevents other sexually spread diseases and unwanted pregnancies, said the study leader, Dr. Robert M. Grant of the Gladstone Institutes, a private foundation affiliated with the University of California, San Francisco. But many men don't or won't use condoms all the time, so researchers have been testing other prevention tools.

AIDS drugs already are used to prevent infection in health care workers accidentally exposed to HIV, and in babies born to infected mothers. Taking these drugs before exposure to the virus may keep it from taking hold, just as taking malaria pills in advance can prevent that disease when someone is bitten by an infected mosquito.

The strategy showed great promise in monkey studies using tenofovir (brand name Viread) and emtricitabine, or FTC (Emtriva), sold in combination as Truvada by California-based Gilead Sciences Inc.

The company donated Truvada for the study, which involved about 2,500 men at high risk of HIV infection in Peru, Ecuador, Brazil, South Africa, Thailand and the United States (San Francisco and Boston). The foreign sites were chosen because of high rates of HIV infection and diverse populations.

More than 40 percent of participants had taken money for sex at least once. At the start of the study, they had 18 partners on average; that dropped to around six by the end.

The men were given either Truvada or dummy pills. All had monthly visits to get HIV testing, more pills and counseling. Every six months, they were tested for other sexually spread diseases and treated as needed.

After a median follow-up of just over a year, there were 64 HIV infections among the 1,248 men on dummy pills, and only 36 among the 1,251 on Truvada.

Among men who took their pills at least half the time, the risk of infection fell by 50 percent. For those who took pills on 90 percent or more days, risk fell 73 percent. Tests of drug levels in the blood confirmed that more consistent pill-taking gave better protection, and in one subgroup, the reduction in risk was 92 percent.

The treatment was safe. Side effects were similar in both groups except for nausea in the Truvada patients. Weight loss also was more common in the drug group, but it occurred in very few. Further study is needed on possible long-term risks.

All participants will get a chance to take Truvada in an 18-month extension of the study to see if men will take the pill more consistently if they know it helps, and whether that provides better protection. About 20,000 people are enrolled in other studies testing Truvada or its component drugs around the world.

The government will review all ongoing prevention studies, such as those of vaccines or anti-AIDS gels, and consider whether people getting dummy medicines should now get Truvada since it has been shown effective in gay men.

Gilead may seek approval to market Truvada for prevention, said Dr. Howard Jaffe, president of the company's philanthropic arm. Doctors can prescribe it for this purpose now if patients are willing to pay for it, and some already do.

Some people have speculated that could expose Gilead to new liability concerns, if someone took the pill and then sued if it did not prevent infection.

"The potential for having an intervention like this that has never been broadly available before raises new questions. It is something we would have to discuss internally and externally," Jaffe said.

Until the CDC's detailed advice on Truvada is available, the agency said gay and bisexual men should use condoms consistently and correctly, get tested and treated for HIV and other sexually transmitted diseases, get counseling and reduce their number of sexual partners.

More information:
CDC advice: http://www.cdc.gov … stp/newsroom

AIDS information: http://www.aidsinfo.nih.gov

and http://www3.niaid. … ics/HIVAIDS/

Pill study: http://www.iprexnews.com

Journal: http://www.nejm.org

UNAIDS: http://tinyurl.com/krq7kr

Prevention efforts: http://www.avac.org

Analysis: Pope's comments add to debate on condoms

21 nov 2010 -- With his striking comment on condoms and AIDS, Pope Benedict XVI has started a new chapter in the complex church debate about morality and preventing the spread of HIV.

The Roman Catholic prohibition against artificial contraception is not in question, but Benedict could be carving out a very rare exception for the use of condoms.

Benedict said that condoms are not a moral solution to stopping AIDS. But he said in some cases, such as for male prostitutes, their use could represent a first step in assuming moral responsibility "in the intention of reducing the risk of infection."

He made the remarks in an interview with a German journalist, Peter Seewald, and published as the book, "Light of the World: The Pope, the Church and the Signs of the Times." The Vatican newspaper L'Osservatore Romano ran excerpts on Saturday ahead of the book release Tuesday.

Benedict's comments put a spotlight on a nuanced discussion within the church about how best to address the scourge of AIDS.

The pope had previously said that condom use exacerbates the AIDS crisis. Some church officials echoed the sentiment, arguing that condoms are not foolproof and give people a false sense of protection. Abstinence and fidelity are the only way to stop HIV, they said.

Still, the Vatican never released an official, authoritative policy on condoms and AIDS, and cardinals from around the world often took positions on the issue that differed significantly.

William Portier, a Catholic theologian at the University of Dayton, a Marianist school in Ohio, has not yet read the book, but said it would be wrong to conclude that the comments mean the pope has made a fundamental change in church teaching.

"He's not going to do that in an offhand remark to a journalist in an interview," Portier said.

The pope's circumspect remarks should also not be viewed as encouraging condom use.

However, they could be read as making a distinction between greater and lesser evils, or what moral theologians call double effect, said Michael Baur, a philosopher at Fordham University. An evil may be tolerated for an intended good - in this case, disease prevention.

It is far from the first time such an argument has been made within the church.

The Rev. Martin Rhonheimer, an Opus Dei priest and ethics professor at the Pontifical University of the Holy Cross in Rome, argued in 2004 that an HIV-infected married man who uses a condom to protect his wife from the virus is not trying to block a pregnancy, but to prevent infection. His actions, therefore, could be seen as in accord with Catholic teaching.

"It's an interesting application of ancient moral principles," said Nicholas Cafardi, a canon lawyer and former dean of Dusquesne University School of Law. "Even if you are performing an otherwise evil act, you can mitigate the evil of the act."

Seewald's book is being released at a time when the pope and the Vatican have tried to overcome their widespread problems in communicating the church's message. Some analysts suggested that the pope's comment on condoms in the book could be just another in a series of public relations missteps.

The English publisher of the book, the Rev. Joseph Fessio of Ignatius Press, argued the pope was not justifying condom use, but was noting that protecting someone from the disease shows the signs of taking moral responsibility for another person.

In the book, the pope also reaffirms church teaching that sex should be between a married man and woman and that artificial contraception blocks God's plan for bringing life into the world.

Yet, even with just the narrow example he gave in the interview, Benedict has created an opening for Catholic bishops in Africa and elsewhere to renew their argument that condoms must be part of the fight against the spread of HIV.

Selenium may slow march of AIDS

29 nov 2008--Increasing the production of naturally occurring proteins that contain selenium in human blood cells slows down multiplication of the AIDS virus, according to biochemists.
"We have found that increasing the expression of proteins that contain selenium negatively affects the replication of HIV," said K. Sandeep Prabhu, Penn State assistant professor of immunology and molecular toxicology. "Our results suggest a reduction in viral replication by at least 10-fold."
Selenium is a micronutrient that the body needs to maintain normal metabolism. Unlike other nutrients, which bind to certain proteins and modulate the protein's activity, selenium gets incorporated into proteins in the form of an amino acid called selenocysteine.
These proteins – selenoproteins – are especially important in reducing the stress caused by an infection, thereby slowing its spread.
Upon infecting a person, the virus quickly degrades selenoproteins so that it can replicate efficiently. It is unclear just how the virus is able to silence these proteins but Prabhu and his colleagues believe that stress inflicted on cells by the rapidly dividing virus, which produces a key protein known as Tat, is the likely culprit.
Tat is one of about 14 odd proteins produced by HIV during the first stage of infection. The job of these proteins is to trigger the expression of all the other genes that the virus needs to sustain itself. In addition, Tat also plays a key role in helping the virus replicate.
One of the proteins that targets Tat is a selenoprotein known as TR1.
"Since HIV targets the selenoproteins, we thought that the logical way to deal with the virus is to increase the expression of such proteins in the body," explained Prabhu, whose team's findings are outlined this week (Nov. 28) in the Journal of Biological Chemistry.
Researchers first isolated blood cells from healthy human volunteers who did not have HIV, and infected those cells with the virus. Next, they added tiny amounts of a selenium compound – sodium selenite – into the cell culture to see the effect on viral replication.
Results from the tests indicate that the addition of selenium inhibits the replication of HIV at least 10-fold, compared to cell cultures in which no selenium is added. When the researchers selectively reduced production of the selenium containing TR1 protein, they observed a 3.5-fold increase in viral replication.
"This confirms that while increasing the expression of TR1 has a negative impact on the replication of HIV, reducing it helps the virus replicate more efficiently," explained Prabhu. He believes that TR1 works by upsetting the chemical structure of Tat, which in turn reduces the virus' ability to replicate.
"Once we fully understand the function of these selenium proteins, it will give us a handle to come up with more effective drugs," said Prabhu, whose work is partly funded by the National Institutes of Health.

Speaking Out for a Group Once Unheard-Of: Aging With AIDS

By KAREN BARROW

12 nov 2008--In the early 1990s, a diagnosis of AIDS was both a likely death sentence and a stigma. There were few treatment options, and many Americans were terrified of people infected with H.I.V.

Today, because of antiretroviral therapy and an array of drugs to treat both symptoms and side effects, AIDS has become a chronic condition to be managed, at least in the developed world. No longer is the face of AIDS emaciated and covered with lesions; Americans with the disease are stronger and healthier, their concerns fading from public view.

Myron Gold, 67, is one of them. In 1993, Mr. Gold was walking in Manhattan around Christmastime when he collapsed and was rushed to the emergency room. A social worker later walked in and loudly announced that he had H.I.V.

Mr. Gold remembers the panic on the faces of the other patients. “When you said that in ’93, you emptied the whole emergency room,” he said. “Everyone ran for their lives.”

Still, he was unfazed by his diagnosis. A former fashion designer who became an AIDS and gay-rights activist, he was already familiar with the disease and how it ravaged the body. He was given a prescription for AZT, the most common treatment at the time, and was told he had six months to live.

Fifteen years later, he is alive and relatively well — and that, paradoxically, is the problem.

“This is not an illness about people in their 20s and teens,” he said. “This is an illness about every age spectrum, from young to old.”

In fact, 29 percent of those infected with H.I.V. are over 50. And because the immune system deteriorates with age, the virus is all the more aggressive in older people.

“I’ve been through 28 medications,” Mr. Gold said. His T cells — a component of the immune system, used as a marker of its health — “are low and they’re not working.”

Moreover, conditions that are often part of the aging process, like arthritis and dementia, can also be caused by H.I.V. So sorting through symptoms and effectively treating them — not to mention avoiding dangerous drug interactions — can be daunting.

There is also an alarming rate of infection among older Americans. In 2005, 15 percent of new H.I.V. and AIDS diagnoses were among people over the age of 50, according to the Centers for Disease Control and Prevention. Yet government recommendations call for routine AIDS screening only up to age 64, omitting the elderly population.

“What about people 65 and older?” Mr. Gold asked. “They’re having unprotected sex, they’re using drugs.”

He says that is why he continues his advocacy for people with AIDS and for stronger prevention efforts. He sits on both the New York and national boards of the nonprofit group Association of H.I.V. Over 50, attends City Council meetings and has spoken before Congress and the New York Legislature.

Not long ago, he visited a senior center in the Canarsie section of Brooklyn to discuss safe sex practices. The women who attended, “all over 80 years old,” he said later, rushed toward the table afterward for the free condoms he was distributing. (“They said to me, ‘It’s not for me, it’s for my grandson,’ ” he said.)

Politicians don’t like to talk about the spread of AIDS among the elderly, Mr. Gold says; nobody wants to hear about Grandma’s sex life. But he adds that change cannot happen without open discussion.

Mr. Gold is proud that he has long outlived his initial diagnosis, but AIDS has weakened his body and he now relies on an electric scooter to get to advocacy meetings and speaking events. Still, he keeps going.

“My work is what feeds me now,” he said. “Call me in 10 years, I’ll still be here.”

Circumcision Benefit In AIDS Is Divided

By REUTERS
WASHINGTON , 08 oct 2008— There is not enough evidence to show that circumcision reduces the risk of AIDS in sex between men, researchers are reporting, even though previous studies in Africa have shown its pronounced benefit in reducing AIDS from heterosexual sex.
“Over all, we’re not finding a protective effect associated with circumcision for gay and bisexual men,” said Gregorio A. Millett of the Centers for Disease Control and Prevention, the lead author of a report that appears Wednesday in The Journal of the American Medical Association.
The researchers based their conclusions on a review of 15 studies involving 53,567 gay and bisexual men in eight countries, including the United States, where nearly half of the 1.1 million people infected with the AIDS virus are men who have sex with men.
Circumcised men were 14 percent less likely to be infected with the human immunodeficiency virus, or H.I.V., than those who were uncircumcised, but the finding was not statistically significant, the researchers said.

Advocates Share Ideas in Teaching About AIDS

By MARC LACEY and LAWRENCE K. ALTMAN
MEXICO CITY, 11 AUG 2008 — Like most scientific conferences, the 17th International AIDS Conference, which ended here on Friday, had its share of researchers presenting and discussing the findings of multiyear investigations in clinical terms.
There was “a ‘planting and eating soybean’ project for people living with H.I.V./AIDS in rural Anhui, China,” “situational analysis and client satisfaction evaluation of A.R.T. centers in India” and “coordinating procurement planning using logistics data,” to name but a few such studies.
Mixed among the strait-laced scientists, though, were activists wearing condom costumes and T-shirts that asked, “Got AIDS?”
More than a quarter of a century since the AIDS epidemic was first recognized, the advocates say, they must be increasingly imaginative in their efforts to educate the public about the disease. Posters on display showed condom-shaped superheroes sailing through the air and oversize insects, representing the virus, having sex with unsuspecting victims. The worst thing, those involved in drawing attention to the epidemic say, is to be so dull that people’s eyes glaze over.
“There is a need to renew and freshen efforts because the virus does not get bored, nor does it fail to find new people at risk every year,” said Dr. James W. Curran, who led the AIDS Program at the Centers for Disease Control and Prevention for many years before becoming dean of the Rollins School of Public Health at Emory University.
One attention-getting advertising campaign on display — called “If I were H.I.V. positive...” — was created by a French group called AIDES. For two years, AIDES has printed posters and postcards and created advertisements using photographs of prominent people above questions meant to challenge stereotypes about infected people.
“If I were H.I.V. positive, would you let me be your doctor?” says one ad bearing the likeness of Dr. Pedro Cahn, the immediate past president of the International AIDS Society, which ran the meeting.
Another showing a blonde woman asked, “If I were H.I.V. positive, would you invite me to your home?” The picture was of Crown Princess Mette-Marit of Norway.
After former President Bill Clinton gave the keynote address on Monday, Floriane Cutler, an AIDES staff member, ducked under a rope and handed him a poster that the group had prepared of him in the hope that he would approve its distribution.
“Would I ever have been president of the United States, if I were H.I.V. positive?” it read. The group used a photo of Mr. Clinton that it had downloaded from the Internet.
Ms. Cutler said Mr. Clinton listened to her quick spiel about the idea behind the antistigma campaign, smiled at her and then moved along with a copy of the poster in his hand.
During France’s presidential campaign last year, the group printed posters of all the candidates. Nicolas Sarkozy, who eventually won, was the toughest to deal with, the group said. His representatives did not initially respond to the questionnaire they were sent seeking his positions on AIDS-related issues or approve an ad campaign.
So the group pressed him into it with a poster that asked: “Even though I don’t care about AIDS, will you vote for me?”
In Mr. Clinton’s case, the group has no plans to issue such a challenge. Olivier Denoue, deputy managing director of AIDES, said Mr. Clinton’s foundation was doing important work on combating AIDS in the developing world and that the former president was regarded as a leader in the field. But the group is eager for an answer on whether he will join the actors, sports figures and other celebrities, most of them French, who are already part of the advertising campaign.
And AIDES is already preparing a backup plan in case Mr. Clinton, whose office did not respond to a request for comment on the campaign, says no.
“If we don’t get Bill Clinton,” Ms. Cutler said, “maybe we’ll get Madonna or Barack Obama or Sharon Stone.”

Progress Has Been Made in Fight Against AIDS, but Not Enough, U.N. Report Says

By CELIA W. DUGGER
JOHANNESBURG, 03 jun 2008 — The good news on AIDS: Nearly a million people began life-prolonging drug treatment in developing countries last year. The bad news: 2.5 million people were newly infected with H.I.V.
As new infections continue to far outstrip efforts to treat the sick, the United Nations released a progress report on Monday that highlighted both the notable gains in combating the AIDS epidemic and the daunting scale of what remains to be done.
Unaids and the World Health Organization, two United Nations agencies, had initially set a 2005 deadline for getting three million people in developing countries onto treatment regimens, but that goal was not achieved until last year. In 2007 alone, the number of people receiving antiretroviral therapy rose by 54 percent. Still, that is less than a third of those believed to need the treatment.
There was also significant headway in providing antiretroviral treatments to help prevent women from infecting their babies with H.I.V., the virus that causes AIDS, during pregnancy and childbirth. About a third of H.I.V.-positive pregnant women got the treatments last year, compared with 10 percent in 2004, with the greatest gains in West and Central Africa, the report found.
“It demonstrates our efforts have started to bear fruit,” Patricia Doughty, a program officer at Unicef, said in a telephone briefing.
But even as health systems geared up to prevent mothers from passing on the disease to their children, the needs of the mothers themselves were neglected. Only 12 percent of H.I.V.-positive pregnant women were assessed for whether they needed treatment themselves. When mothers die of AIDS and their children are orphaned, the opportunities and even survival of the babies who were saved from infection are undermined.
The statistics were laid out in “Towards Universal Access: Scaling up Priority H.I.V./AIDS Interventions in the Health Sector,” a collaboration of Unaids, the World Health Organization and Unicef. It is the annual report that documents the provision of prevention, care and treatment services for H.I.V. and AIDS.
More than a year after clinical trials in Africa found that male circumcision reduced the risk of heterosexual men contracting H.I.V. by about 60 percent, “many high burden countries are exploring how and whether to scale up male circumcision programs,” the report said.
Experts estimate that male circumcision, if widely applied in Africa, could avert two million infections and prevent 300,000 deaths over the next decade.
Dr. Kevin M. De Cock, who heads the World Health Organization’s H.I.V./AIDS department, said performing circumcisions on a large scale was no simple task for overstretched health care systems in southern African countries, where the approach was most needed. He acknowledged that adoption of the strategy had been “relatively slow.”
“There has been progress, but it would be nice to see it faster,” he said.

Study: AIDS drug lifts heart attack risk

By MARIA CHENG
A commonly used AIDS drug appears to nearly double the risk of a heart attack, researchers said Tuesday. In a study published online by the medical journal Lancet, the researchers also said another less frequently used AIDS drug increased the chances of a heart attack by 50 percent. Experts said doctors should be aware of the increased risks, but they did not recommend that patients abandon the two drugs, Ziagen and Videx.
AIDS drugs "are wonderful and lifesaving, but they do have toxicity problems," said Dr. Charlie Gilks, an AIDS treatment expert at the World Health Organization. "It may be that we can continue to use them, but we need to be aware of their long-term problems."
AIDS drugs are used in combinations, so they could be swapped with others if necessary.
Experts have suspected that AIDS drugs could cause heart problems, but no definitive evidence has been available. The drugs come with many side effects, including liver and kidney failure, chronic fatigue syndrome, hepatitis and jaundice.
Jens D. Lundgren of the University of Copenhagen and colleagues analyzed data from more than 33,000 people infected with the AIDS virus in Europe, the United States and Australia to study the long-term effects of five AIDS drugs. The patients were followed for up to five years to see who had heart problems.
In the 754 patients who had heart attacks, 192 had recently taken Ziagen, also known as abacavir, and 124 had recently taken Videx, also known as didanosine.
Those who took Ziagen, included in many AIDS regimens worldwide, had twice the chances of a heart attack compared to patients on other AIDS drugs, the researchers reported. Those on Videx had a 50 percent higher chance. But the risk disappeared six months after patients stopped taking the drugs.
Lundgren said patients already susceptible to heart problems were most at risk.
For men over 40 who smoked and were overweight, the risk of a heart attack were as high as 20 percent. Taking Ziagen increased that risk to nearly 40 percent.
For those without known heart risks, the chances of a heart attack were low — between 1 to 5 percent. Once they were on the drug, their risk ranged from 2 to nearly 7 percent.
No increased heart attack risk was found for patients on the other drugs in the study, zidovudine (AZT), stavudine (Zerit) or lamivudine (Epivir). The medications all block an enzyme that the AIDS virus needs to multiply.
GlaxoSmithKline PLC, which makes Ziagen, said their own analysis of their database of about 14,600 HIV patients, did not support the Lancet study's conclusions.
"We were unable to show any increased risk in heart attacks," said Gwenan White, a company spokeswoman.
The findings could influence how AIDS patients are treated globally, as health authorities like WHO reconsider their treatment guidelines. Ziagen and Videx are currently recommended by WHO for people with HIV worldwide.
"In developed countries, doctors have 24 different antiretrovirals to choose from if one isn't appropriate. But if that happens in resource-poor countries, it is not so simple," said Gilks, who was not connected to the study.
As AIDS patients continue to live longer, experts said they would probably see more of the rarer side effects emerge.
"No drug is risk-free," Lundgren said. "For all patients, it's a matter of finding the right balance."
The research was funded by the European Medicines Agency, a regulatory group, which solicited contributions from makers of AIDS drugs for studies on their long-term effects.

HIV Experts Debate Impact of Failed Vaccine

By DAN CHILDSABC
In the spring of 2007, it was the next great hope for the fight against AIDS. But by the fall, studies of an experimental vaccine against HIV suggested not only that it did not work, but that it actually put those who received it at greater risk of infection.
Now, AIDS experts are assessing the potential damage of the results of these trials to HIV vaccine research. And while some say the blow is enough to send scientists back to the drawing board, others counter that the findings of the studies are still useful, and research must continue.
At the forefront of the debate is Dr. Robert Gallo, co-discoverer of the human immunodeficiency virus (HIV) and head of the Institute for Human Virology in Baltimore. This week, Gallo told the Washington Post of the failed trial, "This is on the same level of catastrophe as the Challenger disaster," referring to the 1986 explosion of the space shuttle Challenger, which dealt a major blow to NASA's space exploration program.
It is a grim assessment with which some researchers agree.
"At this moment, AIDS vaccine trials are basically dead in the water," said Dr. Gary Simon, director of the Division of Infectious Diseases at George Washington University in Washington, D.C. "Furthermore, who would volunteer given the results?
"The hopes of an AIDS vaccine are dashed."
Dr. Charles van der Horst, professor of medicine at the University of North Carolina at Chapel Hill, concurs. "We need to go back to square one and stop the clinical trials until we have better lab and animal data as how to proceed on the vaccine front," he said.
But others say that though the outcome of the trial was unfortunate, it must not be viewed as a death blow to future HIV vaccine research.
"There is no reason to believe that an HIV vaccine cannot work," said Julia Hurwitz, an HIV researcher at St. Jude Children's Research Hospital in Memphis, Tenn. "There are good vaccine candidates that deserve testing in the HIV field & The field is over-reacting to an hypothesis that has not been proven."
And Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition (AVAC), said the comparison of these trials to the Challenger disaster is inappropriate.
"This type of hyperbole does not help the field," he said. "The trials tell us that one vaccine candidate failed  this is a setback but it is not a catastrophe."
Learning From a Halted Study
The idea behind the vaccine, developed by drugmaker Merck & Co., seemed sound. Developers took a common cold virus, weakened it, and loaded it with three fragments of an HIV virus. The idea was to give the recipient's immune system easy "target practice" against the pieces of the HIV, which alone could not cause the disease.
The trials involved about 3,000 subjects in a total of eight countries: Dominican Republic, Haiti, United States, Australia, Brazil, Canada, Jamaica and Peru. The participants in these trials were mostly gay men and female sex workers who were deemed to be at high risk of contracting the infection, and some received the actual vaccine while others got ineffective "dummy" shots.
But last November, Merck released new details about the research  and the news was not good. In each of the studies, not only did it appear that the vaccine was ineffective at preventing infection with HIV, but the results also suggested that the vaccine increased the risk of infection.
In one of the studies, 49 of 914 men who received the vaccine became infected with HIV, while only 33 of the 922 men who got dummy shots became infected. And in another trial, 24 of 741 volunteers who got the vaccine developed HIV, compared to 21 of 762 participants who got dummy shots.
Questions still linger about why such an effect was seen. Still, the results led Merck to put a halt on the studies on Sept. 21.
At the time, top officials with the company and with the National Institutes of Health, which had partially funded the research, said that the failure of this vaccine did not necessarily spell disaster for similar efforts.
"In my mind, this doesn't damn anything," Dr. Anthony Fauci, head of National Institute of Allergy and Infectious Diseases, told The Associated Press in November. "It tells you you need to be very careful with every aspect [of vaccine design and testing]."
Time to Stop Human Trials?
But now, some AIDS researchers say that the failure of the vaccine should shape the way these vaccines are studied  a potential change that could affect more than a dozen other potential HIV vaccines that are still being investigated.
"If they are already enrolling patients, they should stop enrolling new patients until a review of the underlying science can be done by an independent outside committee of scientists," van der Horst said. "If they have not started enrolling patients, they should not start and an independent committee of scientists should review the science on which the study was based in light of the new data."
But Dr. Michael Keefer, head of the HIV Vaccine Trials Unit at the University of Rochester Medical Center in Rochester, N.Y., said though the information yielded by the studies was disappointing, it is still useful. And he said research must continue.
"We're at a crossroads now," he said. "We're at a time where we know something for certain, and unfortunately only way to know things for certain is to do these studies in people."
And Keefer, for one, said he does not think the Challenger analogy offered by Gallo is entirely inappropriate.
"I think its similar in that it caused a pause in the program for a period of time, which is reasonable to understand exactly what happened and why," he said. "The result of that, though, is they went back to approach they had taken. They are still flying shuttles, anyway."

AIDS Patients Face Downside of Living Longer

By JANE GROSS
CHICAGO — John Holloway received a diagnosis of AIDS nearly two decades ago, when the disease was a speedy death sentence and treatment a distant dream.
Yet at 59 he is alive, thanks to a cocktail of drugs that changed the course of an epidemic. But with longevity has come a host of unexpected medical conditions, which challenge the prevailing view of AIDS as a manageable, chronic disease.
Mr. Holloway, who lives in a housing complex designed for the frail elderly, suffers from complex health problems usually associated with advanced age: chronic obstructive pulmonary disease, diabetes, kidney failure, a bleeding ulcer, severe depression, rectal cancer and the lingering effects of a broken hip.
Those illnesses, more severe than his 84-year-old father’s, are not what Mr. Holloway expected when lifesaving antiretroviral drugs became the standard of care in the mid-1990s.
The drugs gave Mr. Holloway back his future.
But at what cost?
That is the question, heretical to some, that is now being voiced by scientists, doctors and patients encountering a constellation of ailments showing up prematurely or in disproportionate numbers among the first wave of AIDS survivors to reach late middle age.
There have been only small, inconclusive studies on the causes of aging-related health problems among AIDS patients.
Without definitive research, which has just begun, that second wave of suffering could be a coincidence, although it is hard to find anyone who thinks so.
Instead, experts are coming to believe that the immune system and organs of long-term survivors took an irreversible beating before the advent of lifesaving drugs and that those very drugs then produced additional complications because of their toxicity — a one-two punch.
“The sum total of illnesses can become overwhelming,” said Charles A. Emlet, an associate professor at the University of Washington at Tacoma and a leading H.I.V. and aging researcher, who sees new collaborations between specialists that will improve care.
“AIDS is a very serious disease, but longtime survivors have come to grips with it,” Dr. Emlet continued, explaining that while some patients experienced unpleasant side effects from the antiretrovirals, a vast majority found a cocktail they could tolerate. “Then all of a sudden they are bombarded with a whole new round of insults, which complicate their medical regime and have the potential of being life threatening. That undermines their sense of stability and makes it much more difficult to adjust.”
The graying of the AIDS epidemic has increased interest in the connection between AIDS and cardiovascular disease, certain cancers, diabetes, osteoporosis and depression. The number of people 50 and older living with H.I.V., the virus that causes AIDS, has increased 77 percent from 2001 to 2005, according to the federal Centers for Disease Control, and they now represent more than a quarter of all cases in the United States.
The most comprehensive research has come from the AIDS Community Research Initiative of America, which has studied 1,000 long-term survivors in New York City, and the Multi-Site AIDS Cohort Study, financed by the National Institutes of Health, which has followed 2,000 subjects nationwide for the past 25 years.
The Acria study, published in 2006, examined psychological, not medical, issues and found unusual rates of depression and isolation among older people with AIDS.
The Multi-Site AIDS Cohort Study, or MACS, will directly examine the intersection of AIDS and aging over the next five years. Dr. John Phair, a principal investigator for the study, which has health data from both infected and uninfected men, said “prolonged survival” coupled with the “naturally occurring health issues” of old age raised pressing research questions: “Which health issues are a direct result of aging, which are a direct result of H.I.V. and what role do H.I.V. meds play?”
The MACS investigators, and other researchers, defend the slow pace of research as a function of numbers. The first generation of AIDS patients, in the mid-1980s, had no effective treatments for a decade, and died in overwhelming numbers, leaving few survivors to study.
Those survivors, like Mr. Holloway, gaunt from chemotherapy and radiation and mostly housebound, lurch from crisis to crisis. Mr. Holloway says his adjustment strategy is simple: “Deal with it.” Still he notes, ruefully, that his father has no medical complaints other than arthritis, failing eyesight and slight hearing loss.
“I look at how gracefully he’s aged, and I wish I understood what was happening to my body,” Mr. Holloway said during a recent home visit from his case manager at the Howard Brown Health Center here, a gay, lesbian and transgender organization. The case manager, Lisa Katona, could soothe but not inform him. “Nobody’s sure what causes what,” Ms. Katona told Mr. Holloway. “You folks are the first to go through this and we’re learning as we go.”
Mr. Holloway is uncomplaining even in the face of pneumonia and a 40-pound weight loss, both associated with his cancer treatment. Has the cost been too high? He says it has not, “considering the alternatives.”
Halfway across the country, Jeff, 56-year-old New Yorker who was found to have AIDS in 1987, said he asks himself that question often.
Jeff, who asked that he not be fully identified, has had one hip replacement because of a condition called avascular necrosis, the death of cells from inadequate blood supply, and needs another to avoid a wheelchair. Many experts think that avascular necrosis is caused by the steroids many early AIDS sufferers took for pneumonia.
“The virus is under control, and I should be in a state of ecstasy,” he said, “but I can’t even tie my own shoe laces and get up and down the subway stairs. ”
His bones are spongy from osteoporosis, a disorder that afflicts many postmenopausal women but rarely middle-aged men, except some with AIDS. No research has explained the unusual incidence.
In addition, Jeff has Parkinson’s disease, which is causing tremors and memory lapses.
He is in an AIDS support group at SAGE, a social service agency for older gay men and lesbians. His fellow group members also say they find the illnesses associated with age more taxing than the H.I.V. infection. One 69-year-old member of the group, for example, has had several heart attacks and triple bypass surgery, and his doctor predicts that heart disease is more likely to kill him than AIDS.
Cardiovascular disease and diabetes are associated with a condition called lipodystrophy, which redistributes fat, leaving the face and lower extremities wasted, the belly distended and the back humped. In addition, lipodystrophy raises cholesterol levels and causes glucose intolerance, which is especially dangerous to black people, who are already predisposed to heart disease and diabetes.
At Rivington House, a residence for AIDS patients on the Lower East Side of Manhattan, Dr. Sheree Starrett, the medical director, said that neither heart disease nor diabetes was “terribly hard to treat, except that every time you add more meds there is more chance of something else going wrong.”
Statins, for instance, which are the drug of choice for high cholesterol, are bad for people with abnormal liver function, also a greater risk among blacks. Many AIDS patients have end-stage liver disease, either from intravenous drug use or alcohol abuse. Among Dr. Starrett’s AIDS patients is 58-year-old Dominga Montanez, whose first husband died of AIDS and whose second husband is also infected.
“My liver is acting up, my diabetes is out of control and I fractured my spine” because of osteoporosis, Ms. Montanez said. “To me, the new things are worse than the AIDS.”
There are no data that compare the incidence, age of onset and cause of geriatric diseases in the general population with the long-term survivors of H.I.V. infection. But physicians and researchers say that they do not see people in their mid-50s, absent AIDS, with hip replacements associated with vascular necrosis, heart disease or diabetes related to lipodystrophy, or osteoporosis without the usual risk factors.
“All we can do right now is make inferences from thing to thing to thing,” said Dr. Tom Barrett, medical director of Howard Brown. “They might have gotten some of these diseases anyway. But the rates and the timing, and the association with certain drugs, makes everyone feel this is a different problem.”
One theory about why research on AIDS and aging has barely begun is “the rapid increase in numbers,” Dr. Emlet said. The federal disease centers’ most recent surveillance data, from 33 states that meet certain reporting criteria, showed that the number of people 50 and older with AIDS or H.I.V. infection was 115,871 in 2005, nearly double the 64,445 in 2001.
Another is the routine exclusion of older people from drug trials by big pharmaceutical companies. The studies are designed to measure safety and efficacy but generally not long-term side effects.
Those explanations do not satisfy Larry Kramer, founder of several AIDS advocacy groups. Mr. Kramer, 73 and a long-term survivor, said he had always suspected “it was only a matter of time before stuff like this happened” given the potency of the antiretroviral drugs. “How long will the human body be able to tolerate that constant bombardment?” he asked. “Well, we are now seeing that many bodies can’t. Once again, just as we thought we were out of the woods, sort of, we have good reason again to be really scared.”
The lack of research also limits a patient’s care. Dr. Barrett says the incidence of osteoporosis warrants routine screening. Medicare, Medicaid and private insurers, however, will not cover bone density tests for middle-aged men.
Marty Weinstein, 55 and infected since 1982, has had a pacemaker installed, has been found to have osteoporosis, and has been treated for anal cancer and medicated for severe depression — all in the last year. He also has cognitive deficits.
A former professor of psychology in Chicago, he presses his doctors about cause and effect. Sometimes they offer a hypothesis, he said, but never a certain explanation.
“I know the first concern was keeping us alive,” Mr. Weinstein said. “But now that so many people are going to live longer lives, how are we going to get them through this emotionally and physically?”

FDA approves novel drug AIDS patients

By LAURAN NEERGAARD, AP Medical WriterMon Aug 6, 5:58 PM ET
The government approved a novel drug Monday to help patients with the AIDS virus who are running out of options, while acknowledging lingering questions about the pills' long-term effects.
Pfizer Inc.'s Selzentry is the first anti-AIDS drug that works by blocking a crucial doorway, called the CCR5 receptor, that the HIV virus often uses to enter white blood cells.
New York-based Pfizer said the pill, known chemically as maraviroc, would be available next month. A spokeswoman said it would cost about the same as other HIV medicines, roughly $900 a month wholesale.
It marks the first in a new class of HIV medicines since 2003, when the FDA approved an injectible "fusion inhibitor" that blocks a slightly later stage of infection.
Researchers have long known that people who naturally lack a working version of the CCR5 doorway are somewhat resistant to HIV infection, and slow to develop AIDS if they do become infected. But the race to develop CCR5 receptor blockers slowed with concerns that this family of drugs might cause serious side effects, including liver or heart damage, and an increased risk of other infections or cancer.
The Food and Drug Administration approved Selzentry after concluding that certain hard-to-treat patients need the new option — but is requiring Pfizer to conduct further research to assess long-term side effects, said Dr. Debra Birnkrant, the agency's HIV drugs chief.
For that select group, Selzentry's "benefits clearly outweigh the risks," Birnkrant said. "That doesn't mean there aren't any risks."
The drug is not for the newly diagnosed, but only for patients whose virus is fast becoming resistant to today's HIV drugs, she stressed.
Those patients also must get a blood test to ensure the HIV strain they have uses the CCR5 pathway. Doctors would send a frozen blood sample to a San Francisco testing company, Monogram Biosciences.
Patients determined to have so-called "R5 virus" would take the twice-a-day pill in addition to their usual HIV drugs.
In a six-month study where patients added either Selzentry or a dummy pill to their regular medicine, Selzentry users were twice as likely to have their virus levels become almost unmeasurable, she said.
Topping the side-effect list is a stern warning that the drug may damage the liver, with symptoms that may at first mimic an allergic reaction. People who develop signs of hepatitis or an allergic reaction should see a doctor immediately.
Pfizer also warned that studies counted more cardiovascular problems, including heart attacks, in Selzentry users. Other side effects include dizziness, upper respiratory infections and fever.
Pfizer said it planned to use the brand name Celsentri outside the U.S. The FDA forced a spelling change for fear of mixups with similar-sounding drugs here, Birnkrant said.

AIDS Spreading Faster Than Treatment

By THE ASSOCIATED PRESS
Access to drugs to fight H.I.V. and AIDS in developing countries has improved recently, but new infections still vastly outpace treatment efforts, health officials said Monday. Three years ago, fewer than 300,000 people in the developing world were receiving antiretroviral drugs; last year, 2.2 million people did, Dr. Anthony Fauci, director of the United States National Institute of Allergy and Infectious Diseases, said at an AIDS conference in Sydney. “However, for every one person that you put in therapy, six new people get infected,” he said.

Experts call for more access to HIV care

By MERAIAH FOLEY, Associated Press WriterSun Jul 22, 5:34 AM ET
The world will not be able to celebrate advances in HIV diagnosis and treatment until the United Nations' goal of universal access to drugs is reached, leading international AIDS researchers said at a conference Sunday.
"We are dealing with a preventable disease and 11,000 people are contracting HIV/AIDS every day. We are dealing with a treatable disease and more than 3 million people are dying every year," said Pedro Cahn, the president of the International AIDS Society.
"Science has given us the tools to prevent and treat HIV effectively. The fact that we have not yet translated this science into practice ... is a shameful failure on the part of the global community."
More than 5,000 delegates from 133 countries have converged on Sydney, Australia, for the Fourth International AIDS Society Conference on HIV Pathogenesis and Treatment, which runs through Wednesday.
Researchers from across the globe will present their findings on the benefits of circumcision for cutting HIV rates through to the latest developments in anti-retroviral drugs.
Lower prices for HIV drugs have significantly improved access to treatment for people in poor countries, but recent World Health Organization figures show the numbers are still far short of the U.N.'s goal of universal coverage by 2010.
Last year, some 2 million people in developing countries were receiving the anti-retroviral drugs that help treat the HIV infection, a 54 percent increase over 2005. But overall, only 28 percent of the world's HIV patients are receiving the life-prolonging drugs.
Dr. Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said the world health community could not celebrate the great breakthroughs in the treatment HIV/AIDS since it was first diagnosed 26 years ago until greater steps are made to prevent the disease.
"Of the projected 60 million infections that will occur by 2015, fully half of them are projected to be able to be prevented with already known and proven prevention methods," Fauci told reporters in Sydney.
"Before we celebrate 26 years since the beginning of extraordinary accomplishments, we're actually going to be judged as a society in what we do in the next 20-26 years," he said. "We cannot sustain a successful effort with HIV without prevention."
Participants at the AIDS conference will be urged to sign a declaration aimed at raising more money for HIV research.
The so-called Sydney Declaration calls on national governments and bilateral, multilateral and private donors to allocate at least 10 percent of all HIV/AIDS-related funding to research.
"We believe that without such funding we will fail to maintain a sustained and effective response to the AIDS pandemic," the declaration says.
The conference organizers say this will help speed up the implementation of new drugs and technologies to prevent, diagnose and treat the infection.

Envoy: China makes strides in AIDS fight

By ANITA CHANG, Associated Press WriterTue Jul 17, 4:21 PM ET
China has taken significant steps to fight HIV and AIDS, but still must reach out to more patients in the vast country and overcome a lack of cooperation from some government officials, a U.N. AIDS official said Tuesday.
There are an estimated 650,000 people living with HIV in China, according to the most recent government statistics from 2005. HIV gained a foothold in the country largely due to unsanitary blood plasma-buying schemes and tainted blood transfusions.
"I believe that over the last few years there have been serious progress and good results in the fight against AIDS in China and now the challenge is to sustain these efforts," said Peter Piot, executive director of UNAIDS.
He said successes in China include top-level government commitment and transparency, as well as proper funding, availability of antiretroviral drugs and outreach programs.
"I've been coming to China for 14, 15 years and I can say in the first five or six years there was basically no receptivity in terms of the issue," Piot said. "And now today a lot is going on. You look at budgets, systems are being put in place, I think it's really very different."
Piot recently returned from Shangcai county in Henan province, where blood-buying businesses passed HIV to thousands of people in the 1990s. He toured a clinic and AIDS orphanage.
The number of AIDS deaths declined by 50 percent in Henan province between 2002 and last year, said Wang Longde, China's vice minister of health, who also spoke at the U.N. news conference.
Cases of transfusions using infected blood have dropped since the 1990s. The government has banned blood buying, and forbids blood donations by prostitutes and intravenous drug users.