Kaisernetwork.org (Washington, DC)
26 March 2008
Science & Medicine
HIV/AIDS Vaccine Researchers at NIH Meeting Call for Increase in Basic Research, New Strategies
[Mar 26, 2008]
HIV/AIDS researchers called for an increase in basic research on the virus and new strategies for research into a vaccine on Tuesday during an NIH AIDS Vaccine Summit, the New York Times reports. The summit was held to discuss the future of HIV vaccine research following the recent failure of a Merck vaccine candidate (Altman, New York Times, 3/26). Merck in September 2007 announced it had halted a large-scale clinical trial of its experimental HIV vaccine after the drug failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS. The vaccine candidate also might have put some trial participants at an increased risk of HIV (Kaiser Daily HIV/AIDS Report, 3/25).
Experts at the meeting said that NIH's National Institute of Allergy and Infectious Diseases should support basic research into HIV prevention, testing and treatment strategies. In addition, researchers said NIAID should support efforts to develop animal models of HIV, and they also called for cooperation between scientists developing such models and those developing vaccine candidates (New York Times, 3/26). NIAID Director Anthony Fauci at the meeting said scientists should begin to focus research on discoveries about the immune system, animal models and innovative vaccine concepts (Chase, Wall Street Journal, 3/26). According to Fauci, more fundamental knowledge about HIV, as well as the way the body and experimental vaccines respond to the virus, is needed before a safe and effective vaccine can be developed (New York Times, 3/26). "We need to turn the knob toward [basic scientific] discovery -- nobody should be unclear about that," he said. Carl Dieffenbach, head of NIH's Division of AIDS, said that the "summit does mark a change in our approach."
Several researchers at the meeting -- which drew about 300 scientists from around the world -- said NIAID should fund new, innovative research proposals and support younger scientists who might abandon HIV vaccine research for less challenging fields (Brown, Washington Post, 3/26). Fauci said an initial step would be to trim existing projects to provide $10 million to $15 million in immediate funds for about 30 grants for researchers who propose novel ideas. He added that some of the grants would go to young scientists (New York Times, 3/26).
According to the Post, NIH is spending about $497 million on HIV vaccine research this year, with about $476 million going to researchers not affiliated with the agency. About 47% of the funds go toward basic research, while 38% go toward human testing of vaccine candidates (Washington Post, 3/26). Fauci said that he will try to increase funding for vaccine research (Emery, Baltimore Sun, 3/26).
Reaction
Fauci said that there is not an "immediate solution to the problem," adding that researchers will need to "justify what [they] are doing" and determine the next steps during smaller meetings (New York Times, 3/26). Michael Weinstein, president of the AIDS Healthcare Foundation, called on researchers to "pull the plug on vaccine research," adding, "Do we have any other enterprise that has been studied for 25 years and for which we've spent billions of dollars where we have no results?" He added that there is "no evidence we'll ever have an AIDS vaccine."
Mitchell Warren of the AIDS Vaccine Advocacy Coalition in response to Weinstein said that the failure of the Merck trial "is not the end of the line for AIDS vaccine research," adding that it is a "critical moment in the field" (Washington Post, 3/26). Glenda Gray of the University of Witwatersrand in South Africa added that "any call to halt vaccine funding is like abandoning Africa." Fauci responded that "under no circumstances" would researchers "discontinue AIDS vaccine research" (Wall Street Journal, 3/26). "We will not discontinue research, period," Fauci said, adding, "Not only will we not decrease it, we will in fact try to increase it" (Baltimore Sun, 3/26).
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Drug Access
Indian Generic Drug Maker Strides Acrolab Receives Tentative FDA Approval for Combination Antiretroviral
[Mar 26, 2008]
FDA on Tuesday announced that it has given tentative approval to Indian generic pharmaceutical company Strides Acrolab for its fixed-dose antiretroviral drug that contains lamivudine, nevirapine and stavudine, Reuters/Yahoo! Malaysia News reports (Reuters/Yahoo! Malaysia News, 3/26). Tentative FDA approval means that although existing patents or other issues prevent marketing of the drug in the U.S., the drug is qualified for consideration in the President's Emergency Plan for AIDS Relief (FDA release, 3/24). The FDA approval is for multiple strengths of the combination therapy, according to Dow Jones (Dow Jones, 3/24). The two versions are 30 milligrams, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively, and 40 mg, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively (FDA release, 3/24).
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Across The Nation
Miami Herald Examines Interfaith Service Focusing on HIV/AIDS Awareness
[Mar 26, 2008]
The Miami Herald on Tuesday examined an interfaith Passover service called Seder of Hope in Plantation, Fla., that focuses on HIV/AIDS awareness. The service, which is scheduled for Sunday at Ramat Shalom Synagogue in Plantation, was established by the Jewish AIDS Network and the Jewish Healing Center five years ago. The service has grown from 50 participants during its first year to about 150, according to Elaine Conrad, a JAN board member.
Rev. Naomi King, minister at the River of Grass Unitarian Universalist Congregation in Plantation, said there are many links between Passover and efforts aimed at fighting HIV/AIDS, including the "idea of the need to be free from enslavement to this virus." Most of the people attending the service have been affected by HIV/AIDS in some way, Conrad said.
According to Rabbi Cheryl Jacobs, director of JHC, the interfaith component of the service is important because HIV/AIDS does not "discriminate." This year's service is expected to draw leaders from many Christian and Jewish communities. The service will feature HIV/AIDS informational pamphlets, a display of panels of the AIDS Memorial Quilt, music and a kosher meal.
"We have been touched by this disease in so many ways. And it is still with us," Jacobs said, adding that the service is a way to express pain associated with the disease, as well as faith in the possibility of a cure. The service is a "celebration of love, friendship and support that sustains us and holds us together, regardless of background or belief," Jacobs said (Feinstein-Bartl, Miami Herald, 3/25).
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Arizona Trial Examines Efficacy of Merck's Antiretroviral Raltegravir
[Mar 26, 2008]
The Tucson Citizen on Monday examined a worldwide trial of Merck's antiretroviral drug raltegravir based at the El Rio Community Health Center in Arizona. The trial, which is sponsored by Merck, includes participants who have become resistant to other treatments. According to the Citizen, the study includes 40 different clinics in the U.S., as well as clinics in South America and Europe. Each clinic participating in the trial has six participants in the study, the Citizen reports (Rowley, Tucson Citizen, 3/24).
FDA in October 2007 approved raltegravir for use by HIV-positive people who have not responded to other treatments. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA. Raltegravir is sold under the brand name Isentress (Kaiser Daily HIV/AIDS Report, 10/15/07).
Fritz Bredeek -- principle investigator for the study in Arizona and a physician at the El Rio HIV Clinic -- said that the study participants "were the least treatable" when they enrolled. Kevin Carmichael, head of the El Rio HIV Clinic, said that he saw HIV-positive people "who were failing therapy." He added that they were "dying" and that raltegravir "saved their lives." Bredeek said that when FDA reviews the results of the study at the 48-week mark, he believes the drug will be approved for use by all people living with HIV/AIDS.
Robin Isaacs, Merck's director of clinical research, said that an unrelated study is under way to examine the effects of raltegravir among people who have never taken antiretrovirals. Those results will be presented to FDA at the end of the year, the Citizen reports (Tucson Citizen, 3/24).
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Global Challenges
India's National AIDS Project Reaching Out to MSM, Other Groups
[Mar 26, 2008]
Officials with India's National Aids Control Project III are focusing their prevention efforts at men who have sex with men, as well as other vulnerable groups, in an effort to reduce the number of new HIV cases in the country, the Times of India reports. According to the Times, the other groups include long-distance truck drivers, prison inmates, migrants, refugees and homeless children. Officials aim to reduce the number of new HIV cases by 60% in high prevalence states during the project's first year, the Times reports.
Bindumadhav Khire of the men's sexual health organization Sampathik said that all MSM "should not be put under only one category." He said that truck drivers, prisoners or soldiers "might get involved with the same gender" because of the absence of female partners, adding, "Unsafe sex in these cases is risky, as it is in the case of opposite gender" partners.
Khire also said that many MSM are reluctant to discuss their situation publicly, adding, "This suffocation results in destructive tendencies and unsafe sexual practices, which could lead to HIV infection." Vijay Nair, project director of Udaan, said that increased efforts should be made to distribute condoms and provide information about their use to help curb the spread of HIV among MSM.
R.R. Gangakhedkar, deputy director of clinical research at the National AIDS Research Institute, said that estimates place the number of long-distance trucker drivers in India at about five million. He added that under "NACP III, we are making efforts to reach them" (Jadhav, Times of India, 3/23).
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