Advocates Applaud Launch of MTN-017, World’s First Phase II Rectal Microbicide Study

[IRMA press release]

 

Trial Design Significantly Enhanced By Strong Community Input

October 2, 2013 – IRMA applauds the launch of the world’s first-ever Phase II rectal microbicide trial. The Microbicide Trial Network’s study, called MTN-017, will test a reduced glycerin formulation of tenofovir gel applied rectally. Volunteers consisting of gay men, other men who have sex with men, and transgender women will participate in the study at sites in the United States and in Thailand, South Africa, and Peru.

“Today feels like every holiday imaginable rolled into one,” said Jim Pickett, chair of International Rectal Microbicide Advocates (IRMA.) “The launch of the MTN-017 study is a milestone long in the making and marks a giant leap forward in the development of safe, effective, acceptable, and accessible products that could be used to prevent HIV during anal intercourse.”

IRMA is pleased to have participated in an intensive community input process with the Microbicide Trials Network that included in-person consultations with advocates and key stakeholders in Thailand, South Africa, Peru and the United States. “The dreams and desires of many men, women, and transgender individuals the world over can be heard loud and clear in the design of the MTN-017 trial. This deep collaboration between scientists and community members is key to the success of this trial and to the rectal microbicide field in general,” said Pickett.

When microbicides were first imagined, they were “vagina-centric.” While many embraced the notion of creating vaginal products women could control, the majority of the HIV/AIDS community— scientists and advocates alike— dismissed the possibility of developing rectal microbicides for use during anal intercourse as an HIV prevention method. It was not considered feasible and the pursuit was seen as hopeless, even laughable. At best, the rectal microbicide field would consist of testing vaginal microbicides for rectal safety, because these products would undoubtedly end up in the rectum despite their intended destination.

IRMA thanks the visionary scientists, advocates and funders like the U.S. National Institutes of Health who bucked prevailing “wisdom” and have remained steadfast in their commitment to developing new HIV prevention methods for use during anal intercourse.

“I feel like we are taking two giant leaps forward today. One in the fight against HIV, and the other in the fight against ignorance and small thinking,” said Pickett.

# # # #

International Rectal Microbicide Advocates (IRMA) is a global network, housed at AIDS Foundation of Chicago, comprised of more than 1,200 advocates, scientists, policy makers and funders focused on rectal microbicide research and advocacy and related issues such as access to safe, condom-compatible lubricants.

Learn more about the MTN-017 study here.

Watch this video “The Rectal Revolution is Here: An introduction to rectal microbicide clinical trials” in English, Spanish, or Thai.

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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.

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Now Playing - The Rectal Revolution is Here

--- Now Playing ---  

"The Rectal Revolution is Here: An introduction to rectal microbicide clinical trials" on YouTube.

The vid, developed by IRMA, Microbicide Trials Network, and Population Council, is available in English,  Spanish and Thai languages.

Watch to learn about the need for rectal microbicides, how clinical trials work, and the importance of volunteers in the effort to make safe, effective, acceptable and accessible new HIV prevention tools.

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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 1,200 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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IRMA Statement on VOICE Results

[Click here for the VOICE press release - "Daily HIV Prevention Approaches Didn’t Work for African Women in the VOICE Study" - from the Microbcide Trials Network]


IRMA, like the rest of new prevention technology researchers and advocates, is disappointed to learn that daily oral Truvada was not found to be an effective HIV intervention among the African women at risk for HIV who participated in the VOICE trial.

We applaud the efforts of the 5,029 women from South Africa, Zimbabwe, and Uganda who volunteered to participate in the VOICE trial. We also commend the Microbicide Trials Network and the National Institutes of Health for successfully executing this extraordinarily ambitious, important trial, and for contributing critical new information to the field.

Today at CROI 2013 we learned that the majority of women in the daily oral Truvada arm of VOICE were not taking their drugs regularly if at all. Rather than a biological explanation, it appears daily oral Truvada was not effective at preventing HIV among the women in the VOICE trial because the drug was not used regularly.

The results of VOICE indicate low adherence to all the drugs/regimens tested in the trial. There was also low adherence in the daily oral tenofovir and daily tenofovir gel arms. Both these arms were closed due to futility in late 2011 after separate reviews by the independent Data Safety and Monitoring Board. VOICE’s daily oral Truvada arm remained open until August 2012.

One of the biggest challenges the field faces is that of adherence. Clinical trials cannot show that a drug works to prevent HIV if trial participants do not take the drug. More must be done to accurately assess adherence during clinical trials in “real time”, and more must be done to develop HIV prevention interventions that people actually want to use, and like to use. But, we won’t be able to refine the drugs, the drug dosing strategies, and/or the drug delivery vehicles to make them more acceptable if trial participants are not adherent along the way.

Science is an iterative process. We are in the “car phone” phase of new prevention technologies - some of the drugs and dosing strategies are perhaps a little clunky. We all want to get to the “i-Phone” phase where we have interventions that are highly acceptable, and desired, but we won’t get there without going through the clunky phase first.

As the field moves forward, issues of recruitment are as important as adherence. Identifying potential trial participants who are most likely to be adherent during the trial is absolutely critical – and very challenging, as the way to achieve this is admittedly not clear.

The MTN-017 trial, a Phase II safety and acceptability study testing a reduced glycerin formulation of tenofovir gel, is getting ready to launch in the coming months. The study will enroll 186 gay men and transgender women at sites in Thailand, South Africa, Peru, and the United States, including Puerto Rico. It will be absolutely essential that MTN-017 volunteers take the study drugs as directed. If adherence is low during this trial, adequate amounts of safety data will not be collected, making it likely that efforts to develop tenofovir gel as a rectal microbicide will be halted permanently. Have no doubt, this would be a huge setback for rectal microbicide research, development, and advocacy efforts in general.

IRMA is very supportive of MTN-017’s inclusion of “real time” monitoring to assess adherence throughout the trial. This will allow investigators to understand and address challenges regarding adherence while the trial is underway, and will help participants make appropriate adjustments in “real time” to improve adherence outcomes. MTN-017 sites should also pay extra special attention to recruitment activities and work to engage and enroll individuals who are most likely to fully participate in the trial, and follow the various regimens being tested as directed.

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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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Cell Damage Caused by Application of Certain Personal Lubricants Does Not Increase Risk of HIV Infection in Tissues Exposed to HIV in a Laboratory, According to a New Study

Below is an adapted version of the official MTN press release that went out moments ago on this study and associated PLoS One paper ("Is Wetter Better? An Evaluation of Over-the-Counter Personal Lubricants for Safety and Anti-HIV-1 Activity"). The IRMA modifications to the release - which do not alter any facts - underscore and emphasize that the study involved exposing human tissues to HIV in a laboratory setting. The study was not a clinical trial. It did not test lubricants in humans - an important fact to properly understand the context of the results.  

While IRMA believes this study is very interesting and adds significantly to our understanding of lubricant safety, the study DOES NOT answer the critical question of what actually happens in humans. Testing lubes on vaginal and rectal tissues in lab settings is important work, but the findings from these studies are unable answer the BIG question out there - which lubes are safer than others when applied rectally or vaginally in HUMAN BEINGS?

IRMA has long prioritized the issue of lube safety, and once again we ask: Where is the commitment to fund and conduct lube safety studies that answer the critical question of REAL LIFE CONSEQUENCES?  

When will we get the answers we need regarding the effects of lube in HUMANS when lube is used IN REAL LIFE? 

--Aidsmap's excellent article on this study: Some sexual lubricants damage cells – but may not increase HIV risk. 

--Click here for more IRMA info on lubricant safety, with resources including a fact sheet and an extensive QA document. 

Cell Damage Caused by Application of Certain Personal Lubricants Does Not Increase Risk of HIV Infection in Tissues Exposed to HIV in a Laboratory, According to a New Study

 PITTSBURGH, Nov. 7, 2012 – The use of certain water-based, over-the-counter personal lubricants can dry out and irritate vaginal and rectal tissue, but does not appear to increase susceptibility to HIV in vaginal tissues exposed to HIV in a laboratory setting, according to a study published today in PLoS ONE. Even so, say study authors affiliated with the National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), more research is needed to fully understand the safety of personal lubricants and their effect on epithelial tissue, the layer of mucosal cells that acts as the body’s first line of defense against sexually transmitted HIV.

“We tested several kinds of personal lubricants [IN THE LABORATORY] and those that did the most damage to cell tissue were hyperosmolar,” said lead study author Charlene S. 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.

“While we know there is cellular toxicity associated with hyperosmolar lubes, the damage did not appear to make cells more vulnerable to HIV infection,” Dr. Dezzutti explained.

Hyperosmolar lubricants contain more salts, carbohydrates and proteins than are typically found inside cells of the vagina or rectum. This imbalance causes epithelial cells to lose water and, as a result, dry out. They are different from iso-osmolar lubricants, which contain the same amount of salts and other ingredients as do the cells.

Study investigators tested 14 brand-name over-the-counter and mail-order water-, lipid- and silicon-based lubricants. Lubricants selected were identified as those most commonly used during anal sex in a survey, conducted by IRMA, of more than 6,300 respondents. Results indicated that hyperosmolar water-based lubricants caused the most damage to the epithelium taken from the vagina and rectum compared to iso-osmolar water- and silicon-based lubricants.

When the researchers applied the lubricants to tissue taken from the vagina and then exposed the tissue to HIV, they found that the lubricants did not increase the tissue's susceptibility to HIV infection.

Other studies are seeking to address HIV susceptibility with rectal tissue.

Of the lubricants tested in the lab, Good Clean Love and PRÉ, both water-based iso-osmolar lubricants, were shown to be least harmful to epithelial tissue, along with two silicon-based lubricants, Female Condom 2 and Wet Platinum. Lubricants that were most toxic to the epithelial tissue (Gynol II, KY Jelly and Replens) also tended to damage “good” bacteria called lactobacillus, which is needed to maintain a healthy genital tract.

“Much more work needs to be done to explore the safety of lubes,” said Dr. Dezzutti. “This was an early study and the jury is still out as to whether hyperosmolar lubes cause damage to the epithelium that in conjunction with other processes, like inflammation, could increase susceptibility to HIV.”

“The most important point for people to take away from this study is that condoms are still the best way to protect against HIV and that lubes should always be used with compatible condoms.”

In addition to Dr. Dezzutti, authors include Elizabeth R. Brown, Ph.D., Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle; Bernard Moncla, Ph.D., Julie Russo, Marilyn Cost, Lin Wang, Kevin Uranker, Ratiya Kunjara Na Ayudhya, Kara Pryke, Lisa C. Rohan, Ph.D., with the MTN and the University of Pittsburgh; and Jim Pickett and Marc-André LeBlanc, with International Rectal Microbicide Advocates, Chicago.

The study was funded by the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, all components of the NIH. 


Click here for more info on lubricant safety from IRMA, with resources including a fact sheet and an extensive QA document.

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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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Meet Clare, A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of  Clare Collins, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Clare  is one of five new bios posted October 30, 2012.



Clare Collins
Pittsburgh, Pennsylvania, USA

"I think rectal microbicides just make sense. The idea of a product that people might actually WANT to use to protect themselves against HIV is a no-brainer."

Clare is an Associate Director of Communications and External Relations at the Microbicide Trials Network (MTN), where she works to promote MTN's rectal microbicide agenda. She also works to strategize the best ways to communicate with others concerning complex health information around biomedical HIV prevention. After starting at the MTN in 2010, she got involved with IRMA through reaching out to IRMA chair Jim Pickett and believes rectal microbicides are a very important part of the HIV prevention research agenda.

Currently Clare is busy planning for the launch of the first-ever rectal microbicide Phase II trial (MTN 017), testing a reduced-glycerin version of tenofovir gel for safety and acceptability among gay men, other men who have sex with men, and transgender women at domestic and international sites. The first site is expected to open enrollment sometime in December 2012. Clare is also part of a team (including IRMA and Population Council) that developed a new educational video, "The Rectal Revolution is Here: An Introduction to Rectal Microbicide Clinical Trials," which will be launched at the same time MTN 017 starts. The video is 13 minutes long and will be available on YouTube. It features animation and live action, and has English, Spanish, and Thai versions.

Clare has been greatly influenced by her mother, who taught her valuable lessons about compassion and concern for others through her battle with cancer, including the necessity of universal access to health care. She is very excited about the future and looks forward to seeing the evolving research in this area.

Thank you, Clare, for all that you do!

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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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AIDSTAR-One - Ready, Set, Rectal Microbicides: An Update on Rectal Microbicide Research and Advocacy

via AIDSTAR-One, by Jim Pickett (IRMA chair)

[This article was written for AIDSTAR-One's "Spotlight on Prevention" series.]

Until recently, microbicide research has focused on vaginal microbicides. Recent initiatives and ongoing studies highlight the need for safe and effective rectal microbicides as part of an essential HIV prevention toolkit.

Around the turn of the millennium, the microbicide field was almost solely focused on the research and development of vaginal microbicides, and community engagement and advocacy aligned with this priority. If scientists and advocates considered rectal microbicides (RMs) at all, it was strictly in the context of the need to test vaginal products for rectal safety, with the understanding that when a vaginal microbicide made it to market, it would likely be used in the rectum as well, or would migrate there during vaginal intercourse.

The realities of the HIV epidemic, though, point to anal intercourse (AI) as a practice that both men and women engage in, and as a significant factor in the spread of HIV and other sexually transmitted infections (STIs). The work of a growing number of scientists and advocates has brought us to the early days of a new consciousness some are calling “the rectal revolution,” where researchers are investigating the role of RMs and related products as essential elements of HIV prevention. This summary describes where we are in the rectal revolution, and where we need to go.

Read the rest.

Download the PDF.

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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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Translating clinical efficacy into public health effectiveness

via Citizen News Service, by Bobby Ramakant

At the recently concluded XIX International AIDS Conference (AIDS 2012), not only the decibels went up on ending AIDS but also sane voices were heard demanding a well-costed and thought-through strategy on how to end AIDS. One of the strategies that will complement a comprehensive HIV prevention, treatment, care and support plan to end AIDS is preventing HIV transmission. In this context, we need to look beyond the Phase III trials in HIV prevention research so that if the product being tested is proved to be effective, we have the means and well-thought plan to make it available for those people in need, without delay.

The HIV prevention research is certainly going ahead with rectal microbicides phase II efficacy clinical trials (MTN017) about to begin in four countries (US, Thailand, South Africa and Peru), US FDA's approval to use 'Truvada' as pre-exposure prophylaxis (PrEP) for HIV prevention, vaginal microbicides research and HIV vaccine science progressing ahead, treatment as prevention (TasP) getting a buy-in as never before, among other positive developments that give us hope.

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.

*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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Community engagement is key as rectal microbicides research progresses ahead

via Citizen News Service, by Bobby Ramakant

While interviewing a range of experts involved with research, development and advocacy of new HIV prevention tools at the recently concluded XIX International AIDS Conference (AIDS 2012), I was reminded of a transgender woman who had said to me in an interview four years back that: "There is no doubt that we need more HIV prevention options - current options don't work especially for people like us... and this is the only possible reason to motivate me to advocate for new prevention options."

This community expert further added: "...'perfect' technologies that disregard social realities don't necessarily deliver results..." The need to engage affected communities as research moves ahead, and engage them with dignity as equal partners is the key to ensure that finally we develop products that are efficient and also when they become available, are actually used by populations in need.

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.

*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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Anti-HIV rectal microbicide research moves ahead

[Citizen News Service and IRMA are collaborating to amplify rectal microbicide research and advocacy, as well as IRMA-led initiatives, throughout AIDS 2012.]

via Citizens News Service, by Bobby Ramakant

It is indeed promising to note the momentum rectal microbicides research and development has attained, more so when there is a global call to end AIDS at the XIX International AIDS Conference (AIDS 2012). Turning the tide of HIV is not possible unless we have safe and effective HIV prevention options for women and men who practice anal sex. Just before the AIDS 2012 opened in Washington DC, the researchers at Microbicide Trial Network (MTN), University of Pittsburgh, USA, got a green signal to go ahead with a major rectal microbicide clinical trial.

According to Jim Pickett, Chair of International Rectal Microbicides Advocates (IRMA) and Director (Advocacy), AIDS Foundation of Chicago: Rectal microbicides are products currently under research – that could take the form of gels or lubricants – being developed and tested to reduce a person’s risk of HIV or other sexually transmitted infections from anal sex. The risk of becoming infected with HIV during unprotected anal sex is 10 to 20 times greater than unprotected vaginal sex because the rectal lining is only one-cell thick, the virus can more easily reach immune cells to infect.

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.

*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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Meet Toon - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Wipas Wimonsate (Toon), the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Toon is one of the six new bios just posted the other day, including individuals from Thailand, Kenya and the US.  Each will be featured on the blog, and you can read all of them here right now.


Wipas Wimonsate (Toon)
Bangkok, Thailand

"As nature is so diversified, why aren't HIV prevention technologies as well? People have different preferences, needs, and capabilities. If we are to be successful in HIV prevention, we have to understand and accept the nature of people, and that is diversity."

Toon is a medical and social researcher and community associate working with the Silom Community Clinic in Bangkok. The Silom Clinic will be a site for the Phase II rectal microbicide expanded safety and acceptability trial called MTN-017, which will be investigating a reduced-glycerin formulation of tenofovir gel applied rectally compared with oral Truvada among HIV-negative gay men, other men who have sex with men (MSM), and transgender women. His site is expected to begin enrolling volunteers in early 2013.

Outside of work, he enjoys playing badminton, reading, and watching television.

He first got involved with IRMA when he was asked to translate some materials on lubricant safety. "Safety of lubricants for rectal use: A fact sheet for HIV educators and advocates" is available in Thai thanks to Toon, as is the document Safety of lubricants for rectal use: "Questions and Answers for HIV educators and advocates."

Toon believes that rectal microbicides provide a protective option for those who choose not to utilize a condom. He also recognizes that rectal microbicides offer a different manner in which to encourage sexual health, and that the endeavor to develop safe, effective, acceptable and accessibile rectal microbicides will be a major contribution to humankind.

Toon has worked closely on the soon-to-be-released IRMA video ("The Rectal Revolution is Here: An Introduction to Rectal Microbicide Clinical Trials") being developed in partnership with the Microbicide Trials Network and Population Council. He is part of the team's Video Advisory Committee and has provided invaluable feedback on content, messaging and language. Translating from English into Thai is rather complicated, and Toon's guidance has been critical to ensure the team "gets it right." He also facilitated the video segments that were recorded in Thailand, and worked closely on the Thai focus groups which were designed and implemented to test the "rough cut" of the video.

Toon was greatly influenced by Dr. Frits van Griensven, the pioneer of HIV studies among Thai gay men, other MSM and transgender individuals. He is very excited for the upcoming studies in Thailand, and is eager to work towards zero new HIV infections rate gay men, other MSM and transgender individuals, locally and internationally.

Thank you, Toon, for all that you do!



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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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Meet Rig Rush - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Rig Rush, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Rig is one of the six new bios just posted the other day, including individuals from Thailand, Kenya and the US.  Each will be featured on the blog, and you can read all of them here right now.


Rig Rush
Los Angeles, California

"By promoting affirming messages that reinforce normalizing overall sexual health and awareness, you can inspire individuals who engage in anal sex to take ownership and accountability of their own behaviors; making confident and informed decisions. In my fierce opinion, that is the basis for HIV and STD prevention."

Originally from Pittsburgh, Rig just moved across country to Los Angeles to become the new Community Mobilization Coordinator at the Black AIDS Institute. He has several interests including going to movies, amusement parks, and taking extremely long walks. He loves meeting different types of people and creating pleasant memories. He also happens to be one of the stars of the soon-to-be-released IRMA video called "The Rectal Revolution is Here: An Introduction to Rectal Microbicide Clinical Trials" being produced in collaboration with the Microbicide Trials Network and Population Council. In the video, Rig relates his experiences as a participant in a rectal microbicide trial with wit, warmth, and passion.

He believes that STD information, brochures and presentations focus on "drips, itches and stenches". Based on the available information, Rig felt he was the only individual who passionately enjoyed receptive anal sex. He also found the small amounts of health-related information regarding anal health/enjoyment highly offensive. Given his frustration, Rig was overjoyed when he heard about the research study that "celebrated the bottom perspective" - the study he talks about in the video.

He acknowledges that "men love sex, and they love unprotected sex, but most men do not think about risk when the moment arises." Condoms protect only when used consistently and correctly. However the concept of rectal microbicides "truly takes prevention and puts it where the rubber meets the road." He finds microbicides in general (both rectal and vaginal) to be the best modern step to fighting the HIV/AIDS epidemic that isn't gay specific. Rectal microbicides have the potential to have a vast and appealing impact on the community collectively.

Rig's advice for IRMA is to remain consistent and committed to promoting awareness and education about rectal microbicides and health. He feels that "the information one obtains from IRMA is very beneficial for the collective gay community."

He will soon be a featured speaker in the satellite session "Rectal Microbicides: Making HIV Prevention Gel" at the International AIDS Conference in Washington, DC with other members of IRMA and allies. The session is taking place in the afternoon on Sunday, July 22, 2012. More info on this event can be found here.

He works to motivate, inspire and unite gay black men and other men who have sex with men around a variety of issues, and continues to support and celebrate black gay men regardless of their HIV status. He strives to help others live productive, informed and authentic lives filled with healthy connections and relationships.

Rig's mother has had the deepest impact on his life. She is his symbol of strength, compassion and authenticity, which shaped Rig into the man he is today. His mother's fearless, positive and audacious appreciation for life ignited a fire that continuously resonates.

Thank you Rig for all that you do!



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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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Meet Pedro - A Friendly Rectal Microbicide Advocate

Check out this interesting mini-bio of Pedro Goicochea, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Pedro is one of six new bios just posted today, including individuals from Kenya,Thailand and the US.  Each will be featured on the blog, and you can read all of them here right now.




Pedro Goicochea
San Francisco, California

"It took us more than 30 years to realize that there is not one unique strategy to prevent HIV acquisition, and that combination prevention is key, and rectal microbicides must be part of the prevention toolbox."

Originally from Lima, Peru, Pedro is in charge of communications and community relations for the iPrEx OLE study, the open-label continuation of the iPrEx trial. iPrEx is the study that showed daily oral use of the ARV drug Truvada among gay men, other men who have sex with men (MSM), and transgender women worked to prevent HIV.

He enjoys his work because of the invaluable opportunities it provides for him to meet interesting people who are working really hard on finding ways to stop this epidemic. He takes pride in the sensitivity his team shows to community members and for highlighting their needs with scientists and stakeholders. Besides iPrEx OLE, Pedro also just finished a couple of other projects related to the feasibility of voluntary circumcision for HIV prevention in gay men and other MSM, and neonatal male circumcision for HIV prevention, in the jungles of Peru.

In his spare time Pedro loves to ride his bike. He enjoys "having destinations that I reach through the effort of pedaling." Pedro's biggest life influence was his mother, but he is also blessed to be surrounded by excellent people that have been an inspiration. In addition, he has lost several friends to HIV and this motivated him to do something about it.

He was introduced to rectal microbicides and IRMA when he met IRMA chair Jim Pickett through IRMA steering committee member and IRMA-ALC co-founder Jerome Galea. He believes that any strategy to help end the epidemic is useful and thinks that rectal microbicides are an important prevention technology because anal sex is the primary mode of HIV transmission among gay men and other MSM, and that women practice anal sex more than is reported or fully understood.

Pedro has played an important role on the soon-to-be-released IRMA video ("The Rectal Revolution is Here: An Introduction to Rectal Microbicide Clinical Trials") being developed in partnership with the Microbicide Trials Network and Population Council. He is part of the team's Video Advisory Committee and has provided invaluable feedback on content and messaging. He also worked closely on the focus groups (especially those conducted in Lima, Peru) which were designed and implemented to test the "rough cut" of the video with different populations to help ensure the proper messages are coming through. He says it has been a very inspirational expereince and he is really looking forward to see the final release. IRMA plans to release the final version of the video in early September, 2012.

Thanks Pedro, for all that you do!


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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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Rectal microbicide research gives hope for HIV protection

via Citizens News Service, by Somya Arora

According to the Microbicides Trials Network (MTN), HIV continues to disproportionately affect racial minorities and men who have sex with men (MSM). MTN estimates that 5 to 10 percent of the world’s population engages in anal sex and globally, MSM are 19 times more likely to be infected with HIV than the general population. Unprotected anal sex is the primary driver of the HIV epidemic among this population. The risk of becoming infected with HIV during unprotected anal sex is 10 to 20 times greater than unprotected vaginal sex, because the rectal lining being only one-cell thick, it allows the virus to easily reach immune cells to infect. 

“Rectal microbicides are critical to turn the tide of the AIDS pandemic as we know that unprotected anal intercourse is the riskiest of HIV related behaviours. Human beings, all over the world, regardless of gender and sexuality, have anal intercourse and a lot of this is unprotected because they do not have access to condoms and/or because of the mistaken notion that anal intercourse is safer than vaginal intercourse with regards to contracting HIV. Having more tools for protection, in addition to what we already have, I think would be absolutely critical,” says Jim Pickett, Director (Advocacy), Chicago AIDS Foundation and founder-chair of International Rectal Microbicide Advocates (IRMA).

In an update on the CHARM (Combination HIV Antiretroviral Rectal Microbicide) Program, Dr Ian McGowan, Professor of Medicine, University of Pittsburgh, and Co-principal Investigator MTN, informs that, “Microbicides are products that can be applied to the vaginal or rectal mucosa with the intent of preventing or significantly reducing the risk of acquiring Sexually Transmitted Infections including HIV. Combination antiretrovirals are more potent and more useful as rectal microbicides. The rationale behind the CHARM programme is that we need a rectal specific combination antiretroviral microbicide.”

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.

*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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AIDS 2012 Satellite: Rectal Microbicides - Making HIV Prevention Gel - Sunday, July 22

Please join IRMA and friends for this rectally riveting satellite session at AIDS 2012 - scheduled for Sunday, July 22 from 3:45 - 5:45pm in Mini Room 8 in the Convention Center - before you are totally burnt out from too much conference! Get the latest news on rectal microbicides - from the scientific and advocacy fronts - and be one of the first on your block to view the "Rectal Revolution is Here" video...

More info in the postcard below.

Click to enlarge

The Bottom Line is this - you don't want to miss it. We hope to see you there.

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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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Did you miss the IRMA/AVAC teleconference on the CHARM program? You're in luck...

The teleconference I am referring to – “And in the beginning, there were Rectal Microbicides” – was held last Thursday. The slides and call recording are available now.

It was a really interesting call – with LOTS of great questions from the participants. Thanks to everyone who made it so dynamic – including presenter Ian McGowan and all the folks who asked really important questions.

Click here for the presentation slides. Click here the call recording.

In this call, Ian McGowan, co-principal investigator of the Microbicide Trials Network and Principal Investigator of CHARM (the Combination HIV Antiretroviral Rectal Microbicide Program) provided an update on what is happening with this innovative program.


Funded by the U.S. National Institutes of Health in 2009, CHARM is an $11 million, five year, multicenter grant intended to advance candidate rectal microbicides from discovery into early clinical development. Rather than simply testing existing vaginal formulations of microbicides, CHARM seeks to develop rectal-specific products from the beginning.


Did you know we save ALL the slides and recordings from all of our teleconferences? Click IRMA’s teleconference page to peruse previous call materials…

http://www.rectalmicrobicides.org/teleconf.php


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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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Meet Ariel - A Friendly Rectal Microbicide Advocate from the United States

Check out this interesting min-bio of Ariel Watriss, the latest in IRMA's "Meet a Friendly Rectal Microbicide Advocate" series on the IRMA website here.  Ariel is one of six new bios just posted a few days ago, including individuals from Kenya, Thailand, the UK, India and Argentina.  Each will be featured on the blog, and you can read all of them here right now.

 

Ariel Watriss
Boston, Massachusetts, United States

"Rectal mircrobicides will help allow people take ownership of their sexual health and in the process empower them."

Ariel is a nurse practitioner certified in both adult primary care and women's health, and currently works at the biomedical research team at the Fenway Institute at Fenway Community Health Center. Sexual health is Ariel's professional passion, and she loves discussing awareness, ownership, and knowledge of her clients' sexual selves. Outside of working, Ariel enjoys reading, spending time with her friends and family, and cycling.

Ariel first became aware of IRMA through her current position at Fenway. She worked on multiple biomedical study teams and Microbicide Trials Network studies, where she was first introduced to the amazing world of microbicides. She works on HIV prevention studies looking at HIV vaccines (HVTN 505), PrEP (iPrEx OLE, and the upcoming HPTN 069) and a vaginal ring study looking at vaginal microbicide use (MTN 013/IPM 026).

Ariel believes microbicides are important among new HIV prevention technologies because they are applicable to real world users. "Offering a prevention measure in a product that is already used, such as lubricant, is so awesome. As a prevention tool, they are accessible and engage people in a direct, yet nonthreatening way."

Ariel's advice for IRMA is to continue to advocate and educate. All of IRMA's work is so important to help HIV prevention measures evolve and grow.

Inspiration and influence for Ariel comes from the people (patients, participants, etc.) who she has had a moment of connection and learning with around their sexual health. Ariel learns from teaching all the time, and continues to be inspired by others' learning.

Ariel is also one of the study clinicians in the upcoming MTN 017 trial (the world's first Phase II rectal microbicide trial), and will be working directly with participants in the study.

Thanks Ariel for all that you do!


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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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And in the Beginning, There Were Rectal Microbicides: An Update on the CHARM Program

Please Register for this Teleconference!

 Please join IRMA, AVAC and Ian McGowan, co-principal investigator of the Microbicide Trials Network and Principal Investigator of CHARM (the Combination HIV Antiretroviral Rectal Microbicide Program) for a thoroughly CHARMing teleconference update on what is happening with this innovative program.

Funded by the U.S. National Institutes of Health in 2009, CHARM is an $11 million, five year, multicenter grant intended to advance candidate rectal microbicides from discovery into early clinical development. Rather than simply testing existing vaginal formulations of microbicides, CHARM seeks to develop rectal-specific products from the beginning.

Find out the latest on CHARM, including the development of a purely rectal formulation of tenofovir gel, and other scientific activities underway and planned.

CHARMed, for sure!

Click here to determine the time of the call in your location.
Slides will be made available on the IRMA website here , for download in advance of the teleconference, and via the ReadyTalk web interface on the day of the call. Audio for the call will be available via phone only.

Click here to Register! If you need an operator to dial you in, please let us know at rectalmicro@gmail.com.

We look forward to your participation in this global teleconference!


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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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Reformulation of Tenofovir Vaginal Gel Safe for Rectal Use

via Eurekalert.org

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 a study published online this week in the Journal of Antimicrobial Chemotherapy. In laboratory tests of rectal tissue, researchers from the Microbicide Trials Network (MTN) found that 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.

"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 lead study author 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, and serve as a dual compartment gel for use in both the vagina and rectum."

Tenofovir gel has shown some 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. Indeed, unprotected anal sex is 10 to 20 times more likely to result in HIV infection than unprotected vaginal intercourse. 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.

Data from an early phase clinical trial of the reduced glycerin gel presented in March 2012 at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), suggested it was safe and acceptable in 65 HIV-negative men and women who used it rectally once a day for one week. Results from this study, called MTN-007, 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.


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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Researchers at CROI 2012 Share First Trial Results on Injectable HIV Drug Used as Prevention

via AidsMap.com, by Gus Cairns

The first trial in humans of an injectable, once-a-month formulation of an HIV drug has found that drug levels were maintained at a level that should in theory be high enough to protect recipients against infection, and that the drug has so far produced very few side effects. The research was presented at the 19th Conference on Opportunistic Infections (CROI), in Seattle.

The small trial at the St Stephen’s AIDS Trust (SSAT) at London’s Chelsea and Westminster Hospital gave 27 women and six men a single injection of the long-acting formulation of the drug rilpivirine, which was licensed as an oral HIV treatment last year as Edurant and is also in the tenofovir/FTC/rilpivirine pill Complera. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) drug and is especially suitable to be turned into a long-lasting injectable form because the daily dose of it required to suppress HIV is very small.

No other HIV drugs are currently in a usable long-lasting injectable form, which will limit the use of long-acting rilpivirine (RPV-LA) in combination therapy, but it could conceivably make an ideal candidate as a prevention drug, as people would not need to remember to take it every day. Other preventative drugs already formulated as monthly injections include the injectable contraceptive Depo Provera and some anti-psychotic drugs.

SSAT recruited 27 HIV-negative women aged 18 to 50, more than 50% of them black African or Caribbean, for the trial and gave them one of three doses of RPV-LA as an intramuscular injection: 300, 600 or 1200mg (the oral dose of RPV is 25 mg/day). Drug levels were then measured over the course of the next twelve weeks in blood, vaginal fluid and in vaginal tissue samples. A substudy gave six men the 600mg dose and measured RPV-LA levels in blood, rectal fluid and rectal tissue samples.

Thirty days after injection, blood and vaginal fluid levels of rilpivirine were about 60 nanograms per millilitre (ng/ml) in both blood and vaginal fluid in women given the 600mg dose, and about 80 and 120ng/ml respectively in women given the 1200mg dose. Blood levels in men given the 600mg dose were about 70ng/ml at 30 days. For comparison, the trough levels of rilpivirine in people taking daily oral doses is about 140ng/ml; but the EC50 (the amount needed to reduce viral replication by 50%) in newly-infected T-cells is 27ng/ml. It is thought these levels should be adequate to prevent HIV infection.

Over the time period, levels of drug seen were about 80% higher in vaginal fluid than in blood in women taking the 300mg dose and about 20% higher in the other two doses: conversely, drug levels in vaginal tissue were about 25% lower than in blood, and 50% lower up to day 14 in the 300mg dose group.

Drug levels in rectal fluid were low but it is thought this was due to sample contamination: concentrations in rectal tissue were about the same as concentrations in blood.

The trial participants complained of very few side-effects apart from tenderness and some swelling at the injection site. There were no allergic reactions, psychological symptoms or effects on heart rate. Safety is of course a major consideration in a drug that remains in the body for up to twelve weeks.

Researcher Akil Jackson said, "There is an obvious need in HIV prevention and treatment for formulations that reduce the need for the user to depend on daily administration,” but added that these were very preliminary results and did not establish what dose would actually be protective. Further safety and drug-level studies in HIV-negative volunteers are to be conducted at the University of Pittsburgh, home of the Microbicide Trials Network, before the drug is given to volunteers with HIV.

 
[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.]

Join IRMA for an Upcoming FREE Global Teleconference on the Latest in Rectal Microbicide Research

Rectal Microbicide Research Update - MTN 007 and MTN 017

There are exciting new developments in the rectal microbicide field. Please join IRMA and AVAC for a FREE global teleconference Thursday, March 15, 10am eastern, featuring Drs. Ian McGowan and Ross Cranston of the Microbicide Trials Network (MTN). Ian (co-principal investigator of the MTN) will share results from the MTN 007 trial - just released at CROI 2012.

Following Ian, Ross will discuss the upcoming MTN 017 trial - a Phase II safety and acceptability trial of the same gel studied in MTN 007 - which will have sites in 4 countries and will start later this year. MTN 017 is the first Phase II trial to be conducted in the rectal microbicide field, and will be the first time that trial sites from outside the U.S. are included.

Click here for more info on the call and to register.

For more info on MTN 007, click here.

For more info on MTN 017, click here.