Feds Fund Implantable PrEP Study

Poz.com reports:

A group of 15 researchers and clinical investigators at Northwestern University received a $17.5 million grant to develop an implant capable of delivering meds that protect against HIV, according to a press release from the McCormick School of Engineering. The hope is that the implants would last for up to a year. The five-year project is underwritten by the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. It brings together researchers from 15 different departments at Northwestern, including Feinberg School of Medicine, Kellogg School of Management and McCormick School of Engineering. In the first stage of the project, researchers hope to develop implants that deliver HIV meds in a controlled way. As Kiser noted: “Technology like this could be an important tool in fighting the global HIV/AIDS pandemic in the U.S. and in low-income countries.”

(Tipped by JMG reader Bill)

New Strategy On Blocking HIV

From the National Institutes Of Health:

A laboratory study led by scientists from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), lends further weight to the potential effectiveness of passive immunotherapy to suppress HIV in the absence of drug treatment. Passive immunotherapy for HIV is an experimental strategy that involves periodically administering broadly neutralizing HIV-specific antibodies (bNAbs) to control the virus. It would be advantageous to control HIV without antiretroviral drugs because of their cost, the potential for cumulative toxicities from lifelong therapy, and the difficulties some patients have adhering to drug regimens and tolerating certain drugs.

Although bNAbs have proven effective at blocking infection by various strains of HIV in the laboratory, their effect on HIV in humans, and particularly on the virus particles that hide in immune cells (called latent viral reservoirs), has been unknown. In this study, NIH scientists obtained HIV from the latent reservoirs of 29 infected people in whom antiretroviral therapy fully inhibited viral replication. In the laboratory, the researchers found that several bNAbs—particularly PGT121, VRC01 and VRC03—effectively blocked HIV from entering the CD4+ T cells obtained from uninfected healthy donors. In addition, the scientists demonstrated in the laboratory that these antibodies could completely block HIV replication in CD4+ T cells obtained from infected individuals receiving antiretroviral therapy.

Clinical trials are already underway.

White House Announces Gene Therapy Is Safe For Drug-Free Treatment Of HIV

The White House tonight issued a press release declaring that the National Institutes of Health has found that initial studies show gene therapy to be "generally safe" as a drug-free alternative for the treatment of HIV/AIDS. Here is the press release in full.

Scientists today report initial results from humans on the safety and tolerability of a novel strategy to curb HIV disease by removing key cells from HIV-infected individuals, genetically modifying the cells to resist HIV infection and returning them to those people. The basic and pre-clinical research on this strategy, which eventually might help people control the virus without drugs, was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Phase I clinical trial was funded by Sangamo BioSciences and was led by NIAID grantee Carl H. June, M.D., with co-investigators Bruce L. Levine, Ph.D., and Pablo Tebas, M.D., all of the Perelman School of Medicine at the University of Pennsylvania, Philadelphia.

The trial built on the observation that people who naturally have a genetic modification in a protein called CCR5 are resistant to HIV infection, and when infected with HIV, progress to AIDS more slowly. CCR5 is a cell-surface molecule, or receptor, that most HIV variants must use to enter their primary target: the CD4+ T cell. In the trial, CD4+ T-cells were collected from each of 12 HIV-infected volunteers whose virus was controlled by anti-HIV therapy. These cells were then treated in the laboratory with molecular tools called zinc-finger nucleases (ZFNs). The ZFNs were designed to snip the DNA within the gene that codes for the CCR5 receptor. This process introduced a genetic mutation rendering CCR5 receptors non-functional. Subsequently, the cells were stimulated to multiply, and each patient received an infusion of 10 billion of their own CD4+ T-cells, with roughly a fifth of the CCR5 genes now mutated.

Four weeks later, in a planned interruption of anti-HIV therapy, half the study participants stopped taking their antiretroviral drugs for 8 to 12 weeks. Investigators found that the experimental treatment was generally safe, and that the genetically modified cells appeared to be protected from HIV infection. In one volunteer who naturally had the desired mutation in half of his CCR5 genes, HIV replication was controlled during the entire 12-week treatment interruption. Future research will include evaluating this experimental treatment in more volunteers, as well as maximizing the frequency of CCR5 disruption by ZFNs and increasing the persistence of the genetically modified cells in the body to achieve a therapeutic effect.

Should further studies demonstrate that the result is long-lasting, it will be interesting to learn how the cost of such a procedure will compare to the cost of traditional drug therapies. My guess is that it will be prohibitive at the start, but cost effective in the long run. It certainly is a better prospect than a lifetime of pill-popping. Experts (and I know you are here) please weigh in.

Tony Perkins On Gay Dick Size

"As a pro-family organization, we would prefer not to use R-rated language in reporting the news--but in our current culture of sexual dysfunction, sometimes it can't be helped. Fiscal and social conservatives should have no trouble uniting in outrage over the news that federal taxpayer money from the National Institutes of Health (NIH) was used to subsidize a researcher studying the size of the male sex organ in homosexual men. The researchers wanted to see what difference size made for the men's 'sexual health.'

"The main difference they found was in the positions assumed when such men engage in a certain sexual act, which former Surgeon General C. Everett Koop rightly called 'simply too dangerous to practice.' Men having sex with men is a high-risk activity that should be discouraged altogether, not subjected to bizarre research at taxpayer expense. Let's tell President Obama, Congress, and the NIH: We'd like to keep our own money and use it to raise our own families." - Family Research Council head Tony Perkins, reacting to a NIH study of gay male penis size.

Another Penis Size Study

A 2009 NIH study of penis size and gay men is just now getting publicity. The study reveals little unknown to most of you, I'm betting.

This particular research resulted in a 2009 report titled, "The Association Between Penis Size and Sexual Health Among Men Who Have Sex with Men." The study reported, among its findings, that gay men with "below average penises" were more likely to assume a "bottom" sexual position, while those with "above average penises" were more likely to assume a "top" sexual position. Those with average penises identified themselves as "versatile" in the bedroom. Though it's difficult to trace exactly how much federal funding went to the project, the study was one of many linked to an $899,769 grant in 2006. The grant was administered by NIH's National Institute on Drug Abuse, and went first to a group called Public Health Solutions and a researcher with the National Development and Research Institutes before going to individual researchers.

The wingnuts are rushing out of the woodwork to denounce the study, of course.

National Institute Of Health To Conduct Unprecedented Study Of LGBT Health

The National Institute of Health is inviting public comment on an unprecedented planned study of LGBT health issues. An insider writes us on how to help:

The Institute of Medicine (IOM), part of the National Academy of Sciences (NAS), has been asked by the National Institutes of Health (NIH) to conduct a report on LGBT health. Nothing like this has been done in the past, although IOM did do a report on lesbian health at the end of the Clinton administration. There is a period of public comment between now and Feb 1. People should be encouraged to take advantage of this. Vague comments ("We need more services for gay men") won't have much impact. Data-based comments will help, but commonplace, vivid examples of health disparities affecting LGBT folks may get noticed.There will be face-to-face meetings with opportunities for public participation, but they are likely to be DC-based and the dates have not been announced. The report will be used by NIH for planning purposes. It's likely that other federal agencies (CDC, HRSA, SAMHSA) will take notice of its findings and Congress usually is interested in the outcome of these reports.

Here's what the report will cover:

· The state of knowledge regarding LGBT health status, health risks, health disparities, and access and utilization of health care;
· The developmental process of childhood and adolescence, in the context of the family; and the impact of family and social acceptance of sexual orientation on mental health and personal safety;
· The effects of age, race, ethnicity, and geography (particularly urban vs rural environments) on the health of LGBT persons;
· The effects of social determinants and cultural factors, including stigma, discrimination, and violence on the health of LGBT persons;
· Assess methodological challenges, including definitional and measurement issues, and study design issues involved in conducting research on the health of lesbian, gay, bisexual, and transgender people, and identify best practices for conducting research in these populations;
· Research gaps and opportunities, study design, and identification of best practices for conducting research in the LGBT population;
· Research training needs that might be impeding the advancement of knowledge about LGBT health.

You can provide feedback on this important and groundbreaking study. As noted by our source, please cite specific examples of issues of LGBT health.