The HIV Prevention Pipeline: A Future of Possibilities

via IRMA/AVAC, presented by Jim A. Turpin

Please register for this teleconference.
 
Meeting Description:

In the last two years there has been great progress in ARV-based prevention strategies - both in terms of PrEP and microbicides. Specifically, there has been enormous excitement and promise around two drugs - tenofovir and Truvada. And more recently, studies testing Dapivirine and Maraviroc have gotten underway.

But...  is that all there is?  What is happening in terms of pre-clinical work?

In this teleconference brought to you by IRMA and AVAC, the NIH's Jim Turpin will examine current and emerging prevention candidates and delivery systems beyond pills, gels and rings, giving us a fascinating peek into the HIV prevention pipeline that we don't often hear about, well before large efficacy trials are imagined, even before small Phase I safety studies are in the picture.

Jim will ask the questions on all of our minds: Is a sustainable pipeline of HIV prevention products beyond the current array of candidates possible? What does that look like? And what can advocates do to better engage in early, pre-clinical efforts years before human trials are in the picture?

Join our call to hear his answers - and provide your own.

Click here to convert the time of this call to your time zone.

When you register for the call, you will be provided a list of global toll-free dial in numbers., If you need us to dial you into the call, please let us know your number when you register. We will only dial in individuals who don't have access to toll-free numbers.

Presentation slides will be made available on the IRMA website here at least a day in advance of the call. You may download the slides and follow along that way, or simply log in to the ReadyTalk web interface on the day of the call and watch the slides there.

This call will be recorded. The recording will be made available on the IRMA website within a day or two after the call.

Questions? Email IRMA at rectalmicro@gmail.com - thanks!

Register for this meeting here.



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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Please look for us on Facebook: www.facebook.com/InternationalRectalMicrobicideAdvocates, and you can follow us on Twitter: @rectalmicro.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.
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aidsmap: NICE says sperm washing is no safer than effective treatment and timed intercourse

via aidsmap.com, by Roger Pebody

Draft UK guidance on fertility treatment says that sperm washing may no longer be necessary for couples where the man has HIV and the woman does not. As long as the man is on effective antiretroviral treatment and unprotected sex is limited to days when his partner is ovulating, “sperm washing may not further reduce the risk of infection.”

On the other hand, the guidance does not support the use of pre-exposure prophylaxis (PrEP) by the HIV-negative partner.

The National Institute for Health and Clinical Excellence (NICE) is an influential body which issues recommendations to the NHS about the most effective and cost-effective treatments to provide. Their draft guidance on fertility treatments – an update to a document previously issued in 2004 - was issued today and is open for consultation.

As in the previous version, people with HIV are not excluded from access to fertility treatments, such as intrauterine insemination (IUI) or in vitro fertilisation (IVF). Moreover the authors have removed a previous recommendation that the implications of the parent’s HIV infection for the child’s welfare “should be taken into account”.

The writing group reviewed in detail the scientific evidence for different methods that a couple could use to become pregnant, where the man has HIV and the woman does not. Previous guidance recommended sperm washing, but the experts also looked at the evidence for effective antiretroviral treatment and for pre-exposure prophylaxis.

“The evidence showed that whilst sperm washing did not appear to completely eliminate the virus in the semen on the basis of post-wash testing of prepared semen, the procedure appears to be very effective in reducing viral transmission in that no cases of seroconversion of the woman or the baby has been documented,” they found.

Read the Rest.


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*Join IRMA's robust, highly-active. moderated, global listserv addressing rectal microbicide research and advocacy as well as other interesting new HIV prevention technologies by contacting us at rectalmicro@gmail.com. Joining our listserv automatically makes you a member of IRMA - a network of more than 1,100 advocates, scientists, policy makers and funders from all over the world.

*Also, please note that shared news items from other sources posted on this blog do not necessarily mean IRMA has taken any position on the article's content.

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Fauci - AIDS: Let Science Inform Policy

via Science, by Anthony S. Fauci

Thirty years have passed since the first cases of acquired immune deficiency syndrome (AIDS) were reported by the U.S. Centers for Disease Control and Prevention. How does this anniversary compare to the 20th or the 10th? The differences are considerable, because we now have an unprecedented opportunity, based on solid scientific data, to control and ultimately end the AIDS pandemic.

More than 60 million people have been infected with human immunodeficiency virus (HIV) worldwide. More than 30 million have died, and 34 million are currently living with HIV infection. In 2009, the most recent year for which data are available, 2.6 million people became newly infected. The burden of HIV/AIDS is overwhelmingly felt in resource-poor countries, especially in sub-Saharan Africa, which are least equipped to deal with the disease. Although the toll is staggering, the scientific progress in HIV/AIDS research over 30 years has been extraordinary, particularly in the development of antiretroviral therapy (ART), which has proven to be life-saving to many millions.

For decades, the idea of ending or even controlling the pandemic was a distant aspiration because we lacked sufficient evidence-based tools to convert the hope to reality. At this 30th anniversary, the situation has dramatically changed: We finally have scientifically validated prevention modalities that clearly work, suggesting that ending the pandemic is feasible. Older, proven prevention tools include the proper use of condoms, needle exchange programs for injection drug users, and antiretroviral treatment of HIV-infected pregnant women to prevent transmission of the virus to their newborn infants. Building on this foundation, recent HIV prevention research also has provided strong scientific evidence that adult male circumcision is highly effective in preventing infection in heterosexual men, that an antiretroviral-based topical gel prevents infection in heterosexual women, and that pre-exposure prophylaxis with ART in men who have sex with men is effective at preventing infection. And in May 2011, a randomized controlled clinical trial demonstrated that early initiation of ART by the infected partner in heterosexual couples, where one partner is HIV-infected and the other not, is highly effective in decreasing transmission of HIV to the uninfected partner.

The fact that treatment of HIV-infected adults is also prevention gives us the wherewithal, even in the absence of an effective vaccine, to begin to control and ultimately end the AIDS pandemic. Of course, the development of an AIDS vaccine would be the ultimate game-changer, and efforts toward this goal are intense. However, the existing armamentarium of scientifically proven interventions immediately offers an unprecedented opportunity to make major gains in the fight against HIV/AIDS. Global implementation of HIV interventions, including scale-up of the delivery of ART, must be accelerated, and this will be costly. Certainly, there are many competing priorities for scarce resources in the global health arena, such as other infectious diseases, maternal and child health, and tobacco control. But if one accepts the tenet that science should inform policy, then the scientific data are speaking loud and clear. Global policy-makers must seriously consider these new data in their priority-setting and decision-making.

Last month, world leaders at the United Nations General Assembly Meeting on AIDS called for providing ART for 15 million people in low- and middle-income countries by 2015, an increase from the 6.6 million currently receiving therapy, plus additional efforts toward universal access to HIV prevention, treatment, and care. An estimated $22 billion to $23 billion annually will be needed by 2015; current spending is approximately $16 billion. Such targeted investments could prevent 12 million infections and 7.4 million AIDS-related deaths by 2020. For the first time in the history of HIV/AIDS, controlling and ending the pandemic are feasible; however, a truly global commitment, including investments by those rich and middle-income countries whose contributions have thus far been limited, is essential. Major investments in implementation now will save even greater expenditures in the future; and in the meantime, countless lives can be saved.

Source.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

2011 Spending Deal Spares NIH Major Cuts

via ScienceInsider

Just as White House officials promised over the weekend, the 2011 funding bill agreed to by Congress and the White House last Friday spares biomedical research from major cuts.

Details released today indicate that the National Institutes of Health (NIH) would receive $30.7 billion, or $260 million below the 2010 level. The 0.8% cut includes $210 million spread across all 27 NIH institutes and centers and the director's office, and $50 million from a buildings account. (Adding a 0.2% across-the-board cut in all non-defense agencies, the total cut will be about $300 million, says David Moore of the Association of American Medical Colleges.)

By contrast, an earlier House bill, H.R. 1, would have slashed NIH's budget by $1.6 billion to $29.5 billion.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

PrEP: A Possible Approval Like No Other

Via Poz, by Tim Horn

The AIDS Healthcare Foundation began a paid advertisement campaign urging Gilead Sciences to refrain from seeking approval from the U.S. Food and Drug Administration for Truvada for use of the combination tablet as HIV prevention, in an approach known as pre-exposure prophylaxis, or PrEP.

The ads were met by an outcry from the community. One prominent organization, the HIV Prevention Justice Alliance, issued a sign-on letter , dated March 16, urging the FDA "to examine the study results of PrEP rather than playing to speculation and fear."

While I agree that PrEP should be considered as an option in the HIV prevention toolkit and would ultimately support an effort by Gilead to expand Truvada's labeling to include PrEP--should the company petition the FDA for approval--I am also of the mind that a green light from the FDA should not be met with the rush-to-treatment that typically follows approval of a drug.

Given how little we know about the safe application of PrEP in a real-world setting--read: outside of a clinical trial--not to mention the expense of a comprehensive prevention program that includes PrEP, I think more feasibility studies need to take place before we consider a widespread HIV prevention program involving PrEP.

Here's what we do know: PrEP is effective in one population of at-risk individuals: men who have sex with men (MSM). The iPrEx clinical trial, sponsored by the National Institute of Allergy and Infection Diseases (NIAID) of the U.S. National Institutes of Health (NIH) and co-funded by the Bill & Melinda Gates Foundation, involved a large sample size (approximately 2,500) of MSMs. The study, which had sound design and statistical analysis, proved Truvada use resulted in significantly fewer infections compared with those using a placebo.

Read the rest

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

PRESS RELEASE: Researchers Reformulate Tenofovir Vaginal Gel for Rectal Use

via Microbicide Trials Network

[The abstract, Tenofovir Gel Reformulation Results in Improved Product Safety for Rectal Application, was presented at a poster session from 2-4 p.m., Monday, Feb. 28. The results of RMP-02/MTN-006 were discussed at a CROI press conference from 7:30-8:30 a.m., Monday, Feb. 28]

‘New’ gel safe in laboratory studies




BOSTON, Feb. 28, 2011 – A change in the formulation of tenofovir gel, an anti-HIV gel developed for vaginal use, may make it safer to use in the rectum, suggests research presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI). In laboratory tests of rectal tissue, researchers from the Microbicide Trials Network (MTN) found the reformulated gel was less harmful to the lining of the rectum than the original vaginal formulation, and just as effective in protecting cells against HIV.

Researchers are now testing the reformulated gel in an early-phase clinical trial with men and women. Results from these and future studies will have important implications for the development of a rectal microbicide that could help protect against HIV or other sexually transmitted infections during anal sex.

Tenofovir gel has shown significant promise in reducing HIV risk in women through vaginal sex. But because the rectal epithelium – the lining of the rectum that serves as the first line of defense against HIV – is much thinner than the vaginal lining, the gel may not be safe or effective to use rectally. By its nature, tenofovir gel is hyperosmolar – contains a higher concentration of sugars and salts relative to cells. This quality could have a harmful effect on the rectal lining by causing epithelial cells to shrink as they purge water to achieve balance. Weakened in this manner, the rectal epithelium may be less able to protect against HIV.

To make tenofovir gel safe and more amenable to rectal use, researchers from CONRAD, a research organization which holds the rights to develop the gel, reformulated it with a reduced amount of glycerin, a common additive found in many gel-like products. In laboratory tests conducted by MTN researchers, the reformulated gel was three times less likely to cause cells in rectal tissue to release water, and equally effective against HIV as the vaginal formulation.

“The lining of the rectum is much more fragile than the vaginal epithelium, so we can’t be certain a product like tenofovir gel that is safe for vaginal use will be completely safe to use in the rectum,” said Charlene Dezzutti, Ph.D., associate professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and principal investigator of the MTN Network Laboratory. “We are very encouraged by our laboratory data that suggest the reformulated gel could be safer for rectal use. These results provide an important bridge to clinical studies, and we have already begun testing it with men and women.”

The new formulation of tenofovir gel is being tested for safety and acceptability in a clinical trial called MTN-007, currently underway at three MTN-affiliated sites at the University of Pittsburgh,

RMP-02/MTN-006, the first-ever clinical study to test the safety of vaginal tenofovir gel in the rectum. These results, which were also presented at CROI, found the gel significantly inhibited HIV in tissue samples, but that men and women in the study did not particularly like it and some experienced uncomfortable gastrointestinal side effects. Researchers are hopeful the reformulated gel now being tested in MTN-007 will address these concerns.

In addition to Dr. Dezzutti, other authors of the study are Lisa Rohan, Ph.D., University of Pittsburgh; J.D. Lynam, Magee-Womens Research Institute; Lin Wang, M.D., Ph.D., Magee-Womens Research Institute; and David Friend, Ph.D., CONRAD, Arlington, Va.

Tenofovir gel contains the antiretroviral tenofovir, which is commonly used in the treatment of HIV. Both the oral and vaginal formulations of tenofovir were developed by Gilead Sciences, Inc., of Foster City, Calif. In 2006, Gilead Sciences assigned the rights for tenofovir gel to the International Partnership for Microbicides of Silver Spring, Md., and CONRAD, of Arlington, Va.

The study was conducted through the MTN, which is funded by the National Institute of Allergy and Infectious Diseases Division of AIDS with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

# # #

The abstract, Tenofovir Gel Reformulation Results in Improved Product Safety for Rectal Application, was presented at a poster session from 2-4 p.m., Monday, Feb. 28. The results of RMP-02/MTN-006 were discussed at a CROI press conference from 7:30-8:30 a.m., Monday, Feb. 28.

About the Microbicide Trials Network

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

PRESS RELEASE: Tenofovir Gel Provides High Level of Protection Against HIV in Rectal Tissue

via Microbicide Trials Network

[The abstract, RMP-02/MTN-006: A Phase I Placebo Controlled Trial of Rectally Applied 1% Vaginal Tenofovir Gel with Comparison to Oral Tenofovir Disoproxil Fumarate, is being presented at a scientific session at CROI 2011 TODAY from 10 a.m. - 12:15 p.m. ET.]



Strongest effect seen in tissue taken from participants after one week of use

BOSTON, Feb. 28, 2011 – A gel developed to protect against HIV during vaginal sex produced a strong antiviral effect when used in the rectum, according to an early-phase study presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI). The results, based on rectal tissue biopsies sampled from HIV-negative men and women who used the product daily for one week, provide the first-ever evidence that tenofovir gel could help reduce the risk of HIV from anal sex, even though the vaginal gel formulation may not be optimal for rectal use.

Tenofovir gel was not especially well-liked by a majority of men and women in the study, yet most reported they would be likely to use the gel if it became available in the future as a method for preventing HIV. Although the study found use of the gel generally safe, side effects were problematic to a few study participants. In hopes of making tenofovir gel more acceptable for rectal use, researchers have since modified the gel and are now testing it in another study.

“We are very encouraged about these findings that indicate applying tenofovir gel topically to the rectum could be a promising approach to HIV prevention,” said Peter Anton, M.D., professor of medicine and director of the Center for Prevention Research at the University of California, Los Angeles (UCLA), who led the study with Ian McGowan, M.D., Ph.D., co-principal investigator of the Microbicide Trials Network (MTN) and professor of medicine at the University of Pittsburgh.

“These are early results, but help set the stage for current and future trials of rectal microbicides and the development of a rectal-specific formulation of tenofovir gel,” added Dr. McGowan, who is leading the second study of the new gel formulation.

Microbicides, products applied on the inside of the rectum or vagina, are being designed and tested to help prevent or reduce the sexual transmission of HIV or other sexually transmitted infections. The majority of microbicide research thus far has focused on products to prevent HIV during vaginal sex. Yet, the risk of becoming infected with HIV from unprotected anal sex may be at least 20 times greater than unprotected vaginal sex, in part because the rectal lining is only one-cell thick compared to the vagina’s multiple layers, making it easier for the virus to reach cells to infect.

The study, known as RMP-02/MTN-006, is the first clinical trial of tenofovir gel for rectal use. Last year, tenofovir gel was shown in a trial called CAPRISA 004 to reduce the risk of HIV infection in women who used it before and after vaginal sex.

Conducted at UCLA and the University of Pittsburgh, RMP-02/MTN-006 tested two products – tenofovir gel and oral tenofovir – in 18 sexually abstinent, HIV-negative men and women. Oral tenofovir, an antiretroviral (ARV) tablet commonly used to treat people with HIV in combination with other ARVs, is being explored as a means to prevent infection in people who are HIV-negative through an approach called pre-exposure prophylaxis, or PrEP.

The trial directly compared the anti-HIV activity of a single dose of oral tenofovir to a single dose of rectally-applied tenofovir gel. This was followed by six days of at-home dosing of tenofovir gel or a placebo gel, with the last and seventh dose given in the clinic. A novel approach was used to determine whether any actual protection was provided by the drug given in the different regimens – single oral, single gel and seven-day gel (or placebo) – in which small biopsies were taken from the rectal lining of the participants using a standard clinical procedure called sigmoidoscopy. The tissue samples were then sent directly to the laboratory where they were exposed to HIV to determine how well study products protected the tissue from infection.

The researchers found that HIV was significantly inhibited in tissue samples from participants who used tenofovir gel daily for one week compared to tissue from participants who used the placebo gel. While a slight anti-viral effect was noted in tissue from participants who received a single dose of tenofovir gel, the finding was not statistically significant. The single dose of oral tenofovir did not provide any protection against HIV in rectal tissue samples.

“These kinds of efforts early in the development phase of rectal microbicides can give us insight into a particular product’s potential efficacy, which enables us to better design and hasten the pace of future clinical trials,” said Dr. Anton.

According to self-reports, only 25 percent of men and women who had used the tenofovir gel said they liked it. However, when asked whether they would consider using the product in the future, 75 percent of these participants reported a high likelihood of future use. Two of the 12 participants who received tenofovir gel reported severe gastrointestinal side effects, including diarrhea and lower abdominal cramps.

“These results tell us that tenofovir gel was relatively safe to use in the rectum for most participants, but we need to address side effects to make it more acceptable to use,” said Dr. Anton, who reported the findings at CROI. “Even though three-quarters of the participants reported they didn’t like the gel, we are very encouraged that the majority would consider using such a product in the future.”

Another study, MTN-007, now underway is using a formulation of tenofovir gel with less glycerin, a common additive found in many gel-like products, in the hope that this will make it better tolerated when used in the rectum. Laboratory tests of the reformulated gel suggest it is just as effective as the original formulation but less irritating to the epithelium – the layer of cells that serves as a protective barrier inside the rectum. The study began in October 2010 and is enrolling 60 men and women at three sites – University of Pittsburgh, University of Alabama at Birmingham and Fenway Health in Boston.

In addition to Drs. Anton and McGowan, other authors of RMP-02/MTN-006 are Ross Cranston, M.D., University of Pittsburgh; Alex Carballo-Dieguez, Ph.D., Columbia University; Angela Kashuba, PharmD, University of North Carolina; Elena Khanukhova, UCLA; Julie Elliott, UCLA; Laura Janocko, Ph.D., MTN and Magee-Womens Research Institute; William Cumberland, Ph.D., UCLA; and Christine Mauck, M.D., M.P.H., CONRAD.

RMP-02/MTN-006 was a collaboration between the Microbicide Development Program at UCLA and the MTN. UCLA’s Microbicide Development Program is funded by the Division of AIDS Integrated Preclinical/Clinical Program for HIV Topical Microbicides at the National Institute of Allergy and Infectious Diseases. The study products were developed by Gilead Sciences, Inc., of Foster City, Calif., which assigned the rights for tenofovir gel to the International Partnership for Microbicides of Silver Spring, Md., and CONRAD, of Arlington, Va., in December 2006. Gilead Sciences and CONRAD provided the study products free of charge.

# # #

Additional information about the study and rectal microbicides is available here.

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners who are devoted to preventing or reducing the sexual transmission of HIV through the development and evaluation of products applied topically to mucosal surfaces or administered orally.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Straight talk with Ellen 't Hoen: Bringing down the price of ARVs

via Nature Medicine, by Asher Mullard


In July, the global health financing mechanism UNITAID established an intellectual property–sharing scheme focused on scaling up access to new and lower-priced antiretroviral drugs in the developing world. The initiative—called the Medicines Patent Pool (MPP)—aims to streamline licensing processes, drive the combination of multiple HIV medicines into one pill and foster the development of drug formulations for children. In September, the US National Institutes of Health (NIH) became the first contributor to the venture, licensing a suite of patents related to protease inhibitors that are used to treat HIV. The task of bringing drug firms and other key stakeholders into the fold now falls on Ellen 't Hoen, a lawyer who became MPP's executive director last month after previously heading up Médecins Sans Frontières' Campaign for Access to Essential Medicines. Asher Mullard spoke to Hoen about the challenges of encouraging companies to share their intellectual property in a normally guarded sector.


Read the rest


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Beyond 2010: Gaps, Challenges and Priorities for the Future of PrEP

From AIDS Research and Human Retroviruses, by Veronese, Turpin and Feuer

A workshop entitled Beyond 2010: Gaps, Challenges, and Priorities for the Future of Preclinical HIV Pre-Exposure Prophylaxis (PrEP) was sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on October 20-21, 2009, in Bethesda, Maryland.

The objective of the workshop was to identify the main gaps in current knowledge, challenges, and priorities for the establishment of a PrEP preclinical pipeline and to also provide guidance for future directions of the field and DAIDS activities in this area. This 2-day workshop, through various presentations and breakout group discussions, specifically addressed four main topics that will be critical in identifying and advancing the next generation of PrEP candidates for clinical testing. The topics were (1) drug discovery, (2) pharmacokinetics (PK) and pharmacodynamics (PD), (3) animal models, and (4) delivery systems for prologed activity.

Read more

Restructuring the NIAID HIV/AIDS Clinical Trials Networks

From the National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Disease (NIAID) is currently planning for the future of NIAID's HIV/AIDS clinical trial networks.

The following links connect to background information discussing the process, scientific priorities, structural components and collaborative opportunities with respect to the restructuring:

Restructuring NIAID's HIV/AIDS Clinical Trials Networks
Future Priorities for NIAID's HIV Prevention Research
Looking Ahead: NIAID's Future HIV/AIDS Therapeutics Priorities
Future Directions for NIAID's HIV Vaccine Clinical Research

Visit the NIAID website for links to staff presentations to the AIDS Research Advisory Committee (ARAC) about the network restructuring and public commentary from the ARAC meeting.

NIAID will also be hosting a public town hall meeting on Tuesday, October 26, 2010 at the Crystal Gateway Marriott in Arlington, VA. For details visit HIAID HIV/AIDS Clinical Trials Networks Town Hall Meeting.

Visit the NIAID Health and Research web page

Early HIV Treatment Helps Immune Function

from The Times of India

A new study has found that HIV-infected individuals who begin antiretroviral theraphy (ART) soon after acquiring the virus may have stronger immune responses to other pathogens than HIV-infected individuals who beging ART later.

The findings from the National Institutes of Health (NIH) suggest that early initiation of ART may prevent irreversible immune system damage and adds to the body of evidence showing significant health benefits from early ART.

Read more

Read the NIH News Release

NIH Releases Biennial Report of the Director

via NIH News Media Branch

Dr. Francis S. Collins, M.D., Ph.D, director of the National Institutes of Health, announced the release of the Biennial Report of the Director, NIH, for fiscal years 2008 and 2009. The report provides an integrated portrait of NIH research activities, making it easy for Congress, advocates and patient groups and the general public to understand the many activities of the agency. This is the second report under the mandate in the NIH Reform Act, which reinvented the NIH Biennial as a consolidated report, replacing many disparate ones. Now on NIH's website, the report will be available in print this fall.

The report contains an assessment of the state of biomedical and behavioral research organized by disease category, investigative approach, and resource. To ensure that the document reflects the work of all 27 institutes and centers, 16 trans-NIH teams gathered, reviewed, and organized information into a standardized format.

"When I began my tenure as NIH director a little more than one year ago, I restated our collective commitment to be as transparent as possible," said Dr. Collins. "We have worked to make the NIH Biennial Report a key resource for NIH's partners, collaborators and constituents — including members of Congress and their staff persons — to help keep them informed about what the agency is doing and why we are doing it."

Read more

Read the full report online

Join IRMA in learning the basic science of drug discovery

via IRMA

Enhance your advocacy skills and bone up on some of the basics. Dr. Jim Turpin of the Microbicide Research Branch at the National Institutes of Health, National Institutes of Allergy and Infectious Diseases, will explain the basic science of drug discovery – the research that happens before we move on to Phase I safety testing in people. Many of us find basic science confusing, daunting, and scary. Jim will show us that it doesn’t have to be any of those things, and is in fact, fascinating!

Register for the Sep 29 teleconference now!

And check out  our slides and recordings from previous IRMA teleconferences here. Previous topics have included lube safety, the epidemiology of HIV among gay men in Africa,  putting pleasure back into prevention, and "the joy of stats."

Dieffenbach - Future Priorities for NIAID’s HIV Prevention Research

via blog.AIDS.gov, by Carl W. Dieffenbach, Ph.D., Director of NIAID's Division of AIDS

[Check out his June 9, 2010 presentation: Restructuring the HIV/AIDS Clinical Trials Networks]

As we begin to discuss the restructuring of NIAID's clinical trials networks, let us first focus on the Institute's HIV prevention research agenda. Developing new biomedical tools that can safely and effectively prevent HIV acquisition and transmission is critical to addressing the global HIV/AIDS pandemic. Currently, we are exploring several promising HIV prevention strategies that, if proven successful, could have a significant impact on reducing the incidence of new infections. These strategies include microbicides — gels, foams, creams, and other formulations designed to prevent sexual transmission of HIV — and pre-exposure prophylaxis (PrEP), attempting to block HIV infection by providing antiretroviral medicines to people who are not infected with HIV but who are at high risk for infection. HIV vaccines are also a major focus of our prevention research efforts, but we will discuss that area specifically in an upcoming blog post.

Vaginally or rectally applied microbicides could potentially provide women and men with a means of protecting themselves against sexually transmitted HIV infection. Non-human primate studies have shown that antiretroviral -based microbicides protect against HIV infection, and these types of products are now being tested in people. Nearly a dozen clinical studies are currently evaluating different microbicide candidates and delivery methods, such as the VOICE trial, which is comparing oral antiretroviral medicines to an antiretroviral-based topical gel for HIV prevention. That study is being conducted by the NIAID-supported Microbicide Trials Network. Future microbicide research efforts will focus on evaluating new products, formulations and routes of administration with the goal of finding a safe and effective microbicide that is reliably used by its intended population.

Read the rest. 

And leave comments! Dr. Dieffenbach is asking for input into NIAID's research agenda.

A Sound Investment:The Multiplier Effect of AIDS Research

Check out the new issue brief from amfAR, The Foundation for AIDS Research, and Treatment Action Group (TAG) on the need to increase investment in AIDS and health research in FY11 and beyond. IRMA members will find that this is an excellent advocacy tool.

The brief includes information on:

- Inflation adjusted AIDS research and NIH funding over time
- Some of the extraordinary accomplishments of AIDS research
- The broad benefits of AIDS research in addressing other diseases
- Scientific opportunities on the horizon
- The costs of failing to adequately invest in AIDS and health research

$17 million grant to help Pitt researcher develop anti-HIV gel

via Pittsburgh Post-Gazette, by David Templeton

Highlight:

Dr. McGowan said the size of the NIH grants reflects a change in Washington, D.C., where the Obama administration has shown greater interest in funding HIV-prevention research.

"The Bush administration had a very high level of discomfort embracing HIV prevention research in men," he said. "But I think in the Obama administration that's a non-issue. They regard domestic HIV prevention in men who have sex with men as an important research priority."

It also reflects growing awareness that not only men have anal sex.

"There's increasing evidence that men and women have anal sex, too," he said. "If we are interested in HIV prevention, we have to look at options for both men and women."

 Read more.

Pitt Receives Grants Totaling $17.5 million for Two HIV Prevention Projects: Multicenter Studies Will Develop Rectal Microbicides and Assess Their Acceptance

via Erie Gay News

A multicenter research team led by the University of Pittsburgh is developing microbicides specifically designed to prevent rectal transmission of HIV, with the further aim of assessing their safety and efficacy in lab and early clinical studies.

Funded by an $11 million, five-year grant from the National Institutes of Health, the Combination HIV Antiretroviral Rectal Microbicide (CHARM) program includes a project that will reformulate existing antiretroviral drugs into topical preparations that can be applied to the rectum, said principal investigator Ian McGowan, M.D., Ph.D., a professor of medicine and of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh School of Medicine and an investigator at the Magee-Womens Research Institute.

“Unprotected receptive anal intercourse is the highest-risk sexual activity for HIV transmission,” Dr. McGowan noted. “Vaginal microbicides already are being extensively studied, and a similar approach might be a very effective way of preventing rectal HIV transmission. It will be critical to determine whether vaginal microbicides are safe and effective when used in the rectum, and also to develop rectal-specific products.”

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World AIDS Day and Rectal Microbicides in the Media

Rectal microbicides were mentioned several times in the news yesterday in conjunction with World AIDS Day. Here are a couple of  items that caught our eye - a rectal sampler as it were.

Statement from the National Institutes of Health on World AIDS Day 2009 

Excerpt:

The National Institute of Allergy and Infectious Diseases (NIAID) accounts for approximately half of AIDS-related spending at NIH. NIAID Director Anthony S. Fauci, M.D., notes that "despite the many advances against HIV/AIDS, much remains to be accomplished. In particular, we urgently need improved prevention strategies and a cure for HIV infection, and NIH is funding hundreds of studies to achieve these goals."

For example, numerous studies are under way to test topical microbicides — creams, gels or other substances for application to the vagina or rectal mucosa to prevent HIV infection. Clinical trials are also testing the efficacy of pre-exposure prophylaxis (PrEP), a daily regimen of one or two antiretroviral drugs that is designed to prevent infection in uninfected individuals who are at high risk for the virus. NIH also plans to test the feasibility of a potential HIV prevention strategy known as test and treat that involves community-wide HIV testing and immediate treatment for people found to be infected.

A vaccine against HIV remains a key NIH priority. The HIV vaccine field recently was encouraged by data from a large clinical trial in Thailand in which a two-stage HIV vaccine regimen demonstrated the first signal from any human study that a protective vaccine for HIV may be possible.

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A Different Longtime Companion: Reflections on World AIDS Day 2009

Dr. David Fawcett's blog

Excerpt:

We need to remain vigilant about AIDS. We need to advocate for new treatment alternatives like rectal microbicides and redesigned prevention efforts. We need to remain informed and fight complacency. We need to end the stigma that surrounds AIDS to this day, undermining both prevention and treatment. Mostly, on this World AIDS Day, we need to remember the pain, the lessons, the courage, and the successes of the past and use them to renew and reenergize our continued work to end AIDS once and for all.

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Magee-Womens Research Institute Receives $17.5 million for Rectal Microbicide Research

Dr. Ian McGowan* (pictured), an investigator with the Magee-Womens Research Institute (MWRI), recently received a total of $17.5 million from the National Institutes of Health (NIH) to conduct two studies involving the development of rectal microbicides.

"This is exciting for the field of HIV prevention research, and especially important in terms of moving the research and development of rectal microbicides forward," said McGowan. "We applaud the leadership and vision of our sponsors at the NIH."

Microbicides are topical products that can be applied to the rectal or vaginal mucosa with the intent of preventing, or at least significantly reducing the risk of HIV acquisition in either compartment.

Recognizing the fact that women in the developed and developing world are at risk of HIV infection through anal and vaginal intercourse, the Microbicide Trials Network (MTN), based at MWRI, is currently evaluating the rectal safety of microbicides designed for vaginal use.

Dr. McGowan’s new studies focus the research towards developing microbicide products specifically designed for rectal use.

The first grant is entitled the Combination HIV Antiretroviral Rectal Microbicides or CHARM program. This is an $11 million, five year, multicenter U19 grant that brings together research groups from the University of Pittsburgh, University of North Carolina, Johns Hopkins Medical School, CONRAD, and the University of California at Los Angeles. The U19 grant is part of the NIH funded Integrated Preclinical Clinical Program and is intended to advance candidate microbicides from discovery into early clinical development.

The second grant is a $6.5 million, four year, R01 grant entitled Microbicide Safety and Acceptability in Young Men with Dr. Alex Carballo-Dieguez as the Co-Principal Investigator. The focus of this grant is to evaluate the safety and acceptability of rectal microbicides in young, ethnic minority men who have sex with men (MSM). Funding for this study comes from the National Institute of Child Health and Human Development as well as the National Institute of Mental Health and will generate critical data from a population of young African American and Latino men who are at the highest risk of HIV infection in the United States. Clinical trial sites will be in Pittsburgh, Boston, and Puerto Rico.

"We need to develop safe, effective, acceptable and accessible rectal microbicides for the millions of women and men worldwide who need options beyond condoms," said Jim Pickett, chair of the International Rectal Microbicide Advocates (IRMA) said. "Our global network of advocates, scientists, policy makers and funders is encouraged to see this work moving forward."

Together with ongoing MTN rectal safety studies and another collaborative grant with the University of Oxford, UK, these two new grants establish MWRI as a leading center for rectal microbicide translational research and will hopefully lead to the development of safe and effective products for individuals at risk of HIV infection through unprotected receptive anal sex.
 

* Dr. McGowan is also a Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition at the University of Pittsburgh Medical Center, with a secondary appointment in the Department of Obstetrics, Gynecology and Reproductive Science.

NEW Rectal Microbicide Trial is Recruiting

Official Title: “A Two-site, Phase 1, Partially-blinded, Placebo-controlled Safety, Acceptability and Pharmacokinetic Trial of Topical, Vaginally-formulated Tenofovir 1% Gel Applied Rectally Compared With Oral 300 mg Tenofovir Disoproxil Fumarate in HIV-1 Seronegative Adults”

Clinical Trial Phase: Phase 1 | Start Date: September 2009

Overall Status: Recruiting

Estimated Enrollment: 18

To date, the majority of microbicide research has focused on the assessment of the safety and effectiveness of vaginal microbicides used for the prevention of HIV transmission via the vaginal compartment. Receptive anal intercourse (RAI) is common among men who have sex with men (MSM), and there is increasing evidence that heterosexual women in the developed and developing world also practice anal sex. It can, therefore, be anticipated that once vaginal microbicides are licensed, they will be used in both the vaginal and rectal compartments. As a consequence, there is a need to evaluate both the rectal and vaginal safety profile of candidate microbicides. Therefore, the primary objective of this study is to evaluate the systemic safety of 1% vaginally formulated tenofovir gel applied rectally.

In addition, this study will evaluate the immunotoxicity of the gel and evaluate its acceptability; it will also use the oral tenofovir disoproxil fumarate tablets (TDF), rectally-applied tenofovir gel,and a placebo gel to compare their systemic and compartmental pharmacokinetic (pK) profiles.

Read the rest of the info on this study here.