Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

Showing posts with label Microbicide Trials Network. Show all posts
Showing posts with label Microbicide Trials Network. Show all posts

14 December 2011

Update on IRMA’s Project ARM – Africa for Rectal Microbicides Strategy Meeting in Addis: Dedication and passion are paving the way forward

  Original content from our Mapping Pathways blog team

“It was an amazing group, and one that moved me to near tears on a number of occasions”

Our colleague Jim Pickett from the AIDS Foundation of Chicago, a Mapping Pathways partner organization, just returned from an inspiring week in Addis Ababa, Ethiopia, where he led a strategy meeting for the International Rectal Microbicide Advocates (IRMA) and then attended the ICASA 2011 conference (read more about both here and here). We checked in with Jim for an update on IRMA's Project ARM (Africa for Rectal Microbicides) strategy meeting, which was held in Dec 2 and 3 (click here for a fact sheet on Project ARM).

The meeting, which was the result of 18 months of planning and coordination, convened about 40 individuals - both invited speakers and guests, including 16 individuals who secured scholarships to attend (out of 145 applicants.) The meeting participants represented countries including Ethiopia, Rwanda, Cameroon, Kenya, Nigeria, Zambia, Malawi, Zimbabwe, South Africa, Uganda, Canada, United Kingdom, and the United States  -researchers, advocates, LGBT people, heterosexual people, and those representing sex workers, prison populations and more.

“It was an amazing group, and one that moved me to near tears on a number of occasions,” says Pickett, who explained that the aim of this meeting was for people to come together and create a strategy, a road map, around rectal microbicide research and advocacy specific to the African context. “I've been to many, many meetings – too many –  in my day and I think the Project ARM meeting was, by far, one of the most productive, inspiring, exciting, energizing, and emotionally moving ones I've ever had the privilege to attend. Yes, I am obviously biased - but it isn't often that events like these make me misty-eyed and put a lump in my throat – repeatedly.”

The journey to getting all these people together for this meeting was not easy, as many faced multiple challenges securing the required visas for travel to Ethiopia. Says Pickett, “There was this incredible energy in the room. We’d been planning this meeting for the past 18 months, and it has been a long journey for all of us to make this happen. A number of the people attending went to extraordinary lengths to get to Addis Ababa. They had to make so many trips to embassies and consulates for visas, so many obstacles were placed in their way to dissuade them from attending, but none of them took no for an answer. The incredible perseverance they exhibited simply to show up was extremely moving.”

The participants spent the two days together getting informed – including sharing the latest updates on rectal microbicide science, rectal microbicide advocacy, issues around LGBT crimininalization, anal sex prevalence, the gay/MSM epidemic, and more. “But we didn't just passively listen to others speak - we broke out into small groups a number of times to unpack what we learned and to come up with priorities and plans for moving forward,” says Pickett.

Four advocacy-focused items and four research-focused items were prioritized, and action steps were developed for each. These included expanded rectal microbicide scientific research activities in Africa, expanded research into anal sex behaviors among African straight and gay/MSM populations, communication/education efforts, and the birth of  the Global Lube Access Mobilization (GLAM) campaign called "And Lube" to support increased access and availability of condom-compatible lubes throughout Africa. Current lubricant access across the continent is absolutely abysmal.

What especially surprised and moved Pickett was the level of enthusiasm and positivity in the room. “A lot of these people come from countries that have seriously troubling environments and where advancing HIV prevention and advocacy is met with extreme homophobia. So I thought that a lot of the discussion would be on the challenges and obstacles-- I mean, so many of the countries we were focusing on are settings where you can’t even think of doing a microbicide trial, let alone discussing sexuality openly without worrying for your safety – yet the participants didn’t get stuck on these negatives. These are men and women who are brave and strong and are committed to fighting for better health and civil rights for the people in their country. It was extraordinarily fulfilling to witness their passion and energy first hand; to see them standing up and doing this work despite the numerous challenges and obstacles in their way.”

Dr. Ian McGowan, co-principal investigator of the Microbicide Trials Network (MTN) attended the meeting, presenting the latest in rectal microbicide science. He also addressed some of the questions regarding the recent closure of the VOICE trial’s study arm testing tenofovir gel. The decision was made due to futility – while tenofovir gel was found to be safe, the trial was not able to prove the gel worked to prevent HIV. See the statement from the MTN for more information. Previously the trial had to drop its tenofovir tablet arm due to futility as well. The Truvada tablet arm in the trial is continuing. “There was a lot of speculation in the room about why it was closed,” said Pickett. Many of the people present speculated that a lack of adherence might have been a factor, said Pickett. “But of course, it’s all speculation at this point, we don’t know what happened, and we won’t till the end of next year likely.” He added that McGowan confirmed that it is still important to move forward on both vaginal and rectal microbicide research and to keep exploring ways to create a more diversified microbicide pipeline (learn more about the microbicide pipeline here and here).

For Pickett, another big highlight was McGowan’s strong validation for Project ARM’s objectives. McGowan, a highly respected veteran in microbicides research, publicly offered MTN support for future Project ARM activities and commended the participants for their collective intellect and passion. Said Pickett, “Ian participated in many of the small break-out groups, and I think he was impressed by the high quality of thought, curiosity, and energy in the room. And to have that kind of validation from someone who is one of the key rectal microbicide researchers on the planet… it was a really big moment for us. There isn’t a doubt in my mind now that Africa is squarely on the rectal microbicide map.”

Pickett also felt that an interesting backdrop to the IRMA meeting was Hillary Clinton’s speech that formalized the Obama administration’s prioritization of LGBT rights globally, helping to bolster rights’ groups on the ground in their fight against discrimination. “At the end of the day,” said Pickett, “if people aren’t free to be who they are, wherever they are, they won’t be able to make use of any prevention technology, let alone rectal microbicides. There’s no point in having a really great microbicide on the shelf if people are not safe, and therefore unable, to access it.”

Jim Pickett is the Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and a member of the Mapping Pathways team. A full report from the Project ARM meeting in Addis, laying out a rectal microbicide research and advocacy strategy for Africa will be released at the Microbicides 2012 conference in Sydney in April 2012. Until then, find updates here.

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

03 October 2011

Closure of oral Tenofovir arm in VOICE Pre-Exposure Prophylaxis trial: PrEP as a “niche intervention”?

via Incidence, by Roger J. Tatoud

The Microbicides Trial Network (MTN) September 28th that its VOICE (Vaginal and Oral Interventions to Control the Epidemic, MTN003) HIV Pre-Exposure Prophylaxis (PrEP) prevention study will discontinue the daily oral tenofovir arm of the trial. The decision follows an interim review of the trial’s data by its Data Safety and Monitoring Board (DSMB) which recommended that VOICE stops evaluating the oral tenofovir tablet (TDF, brand name Viread), because it will not be possible for the study to show a difference in effect between the drug and the placebo tablet (futility) for the prevention of HIV infection in the context of that study. Importantly, the DSMB did not found any safety issues associated with the use of TDF in any arm of the trial.

This is the third PrEP trial, after FEM-PrEP and TDF2, for which an interim review of the trial’s data led to a change of course of the study. Because the four other arms of the VOICE trial continue, there are no data available publicly yet to explain why tenofovir would not show effectiveness in this study when three other studies showed a dramatic reduction in the risk of HIV infection with tenofovir alone or in combination with another antiretroviral (see table below). However, Sharon Hillier and Ian McGowan of the Microbicide Trials Network noted that the study’s population – predominately women in their 20’s, could be an important factor.

“If there’s one thing we’ve learned over the years it’s that unmarried women in their 20s are in a very different place in their lives than married women in their 30s. People in different circumstances will make different choices about their use of condoms, their choice of partners and whether or not to use a biomedical prevention product. As we continue the VOICE trial we recognize that there could be many factors that influenced the outcome with oral tenofovir, and even when we have more information available to us, understanding what exactly happened (or not) will not be simple.”

If confirmed (a full analysis of the data will not be available before several months) this would add to the challenge of defining a strategic use for PrEP in the general population or in populations at risk.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

28 September 2011

MTN Statement on Decision to Discontinue Use of Oral Tenofovir Tablets in VOICE, a Major HIV Prevention Study in Women

via Microbicide Trials Network

VOICE, an HIV prevention trial evaluating two antiretroviral (ARV)-based approaches for preventing the sexual transmission of HIV in women – daily use of one of two different ARV tablets or of a vaginal gel – will be dropping one of the oral tablets from the study. The decision to discontinue use of tenofovir tablets in VOICE comes after a routine review of study data concluded that the trial will not be able to demonstrate that tenofovir tablets are effective in preventing HIV in the women enrolled in the trial. VOICE will continue to test the safety and effectiveness of the other oral tablet, Truvada®, a combination of tenofovir and emtricitabine, and of the vaginal gel formulation of tenofovir.

Importantly, the review, which was conducted by the National Institute of Allergy and Infectious Diseases (NIAID)’s independent Prevention Trials Data and Safety Monitoring Board (DSMB), identified no safety concerns with any of the products being studied in VOICE.

VOICE – Vaginal and Oral Interventions to Control the Epidemic – involves 5,029 women at 15 trial sites in Uganda, South Africa and Zimbabwe. The trial is being conducted by the Microbicide Trials Network (MTN), an HIV/AIDS clinical trials network funded by the National Institute for Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver Institute for Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health.

The study was designed with five study groups: tenofovir gel, an inactive placebo gel, oral tenofovir, oral Truvada and an inactive placebo tablet. The women in each group (about 1,000) are asked to take their assigned study product daily. VOICE is the only trial evaluating the daily use of an ARV tablet – an approach called oral pre-exposure prophylaxis, or PrEP – and a vaginal gel in the same study. This design is important for determining how each product works compared to its control (placebo gel or placebo tablet) and which approach women prefer.

On September 16, 2011, the NIAID Prevention Trials DSMB reviewed VOICE study data for the period between Sept. 9, 2009, when the study began, and July 1, 2011. Based on this interim review, the DSMB determined that it was not possible to show whether oral tenofovir tablets were any better than a placebo for preventing HIV in the women assigned to that study group. The DSMB therefore recommended that the women randomized to the oral tenofovir tablet group discontinue their use of the study product. This recommendation does not apply to the women in the groups using either the tenofovir gel or oral Truvada tablets, or the corresponding placebos; the DSMB recommended that these four study groups continue in VOICE.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

09 May 2011

Presentations from 2011 MTN Annual Meeting Now Available



The 2011 Annual Meeting of the Microbicide Trials Network was held in Washington, DC this past March.

Very informative plenary presentations occurred on the two main days of the meeting. The MTN and all the presenters have graciously provided access to their slide sets. Below are links to each of them - just click on those you find interesting. Please take advantage of this great set of resources.

Presentations from Plenary Sessions on Monday, March 28, 2011

















Presentations from Plenary Sessions on Tuesday, March 29, 2011















[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]