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iPrEx UPDATE • 2ND QUARTER 2009 • VOLUME 1 NUMBER 1

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What is PrEP? Education, counseling and condoms have slowed, but not stopped, the global AIDS epidemic. The world needs new prevention tools to help PrEP studies are investigating whether medications used to treat HIV stop the nearly 2.7 million infection could also be used to help new HIV infections that oc- prevent HIV infection in someone who is This potential new prevencur each year – or 50,000 HIV-negative. tion tool is being studied in clinical trials new infections every week. around the world.

Letter from iPrEx Protocol Chair iPrEx is now mid-way on the road from concept to results. On page 7 of this newsletter, Dr. Javier Lama describes our start in 2004 with community discussions and the subsequent growth of iPrEx in Peru and Ecuador, where enrollment has exceeded our expectations. The Andean teams are now focused on keeping up with data management and promoting adherence and retention in the study.

These teams embrace everyone, including investigators, doctors, nurses, counselors, pharmacists, recruiters, lab workers, community leaders and participants.

Our “adherence” meetings, conducted at the Andean sites in January 2009, were both an opportunity to learn from each other, as well as celebrations of our work, mutual respect and love. We realized that the future of PrEP lies in our hands, and in the hands (and mouths) of iPrEx participants.

iPrEx has earned the support of prevention scientists and advocates around the world. In 2008, the Bill and Melinda Gates Foundation joined with the NIH to help iPrEx expand from our four founding sites in the Andes to a total of eleven sites in the United States, South America, South Africa and Thailand. This expansion increases the diversity of study participants and allows our results to have global significance.

While we wait for iPrEx study results, we should also appreciate our first and most important finding: that communication and community building lie at the heart of HIV prevention. Our work depends on people informing themselves, supporting each other, and taking action to protect themselves and their communities. These actions include participation in research, staying in studies, adherence and much more.

During visits to our 11 iPrEx homes, I have been deeply impressed by the common struggles shared by diverse communities of gay men, MSM and transgendered people: staying free of HIV, managing treatment, finding acceptance and security at home, finding friends and creating livelihoods are pursued with vigor and ingenuity around the world, often in amazingly similar ways. Ultimately, we aim to find ways to arm the struggle against HIV and to celebrate our common pursuits.

Robert Grant, MD,MPH 2

iPrEx iPrExUPDATE UPDATE••2ND 2NDQUARTER QUARTER2009 2009••VOLUME VOLUME11NUMBER NUMBER11

Pre-exposure prophylaxis is not a new approach to preventing disease – medications are also used to prevent malaria, tuberculosis, pneumonia and motherto-child transmission of HIV. In animal studies of PrEP, monkeys that received medication before being exposed to the simian version of HIV were less likely to become infected than those that did not. iPrEx is a global PrEP study sponsored by the U.S. National Institutes of Health (NIH) with co-funding from the Bill and Melinda Gates Foundation. iPrEx volunteers are healthy, sexually active HIVnegative gay men and other men who have sex with men (MSM) and male to female transgendered women who are at high risk of contracting HIV. Half of the study participants receive Truvada®, a once-daily tablet containing the HIV antiretroviral medications Viread® (tenofovir disoproxil fumarate) and Emtriva® (emtricitabine) and half receive a placebo or “sugar pill”. Neither the study volunteers nor the study personnel know which volunteers are receiving active medication or placebo. Everyone in the study receives intensive safer sex counseling, condoms, and treatment of any sexually transmitted infections (STI) to reduce their risk of HIV infection. iPrEx began operations in Lima, Peru in June, 2007, and is now underway in Lima and Iquitos, Peru; Guayaquil, Ecuador; Boston and San Francisco, United States; Cape Town, South Africa; Chiang Mai, Thailand; and São Paulo and Rio de Janeiro, Brazil.

Results of the iPrEx study will help researchers determine whether Truvada can help prevent HIV infection when used in combination with safer sex counseling and condoms. iPrEx is also evaluating the effects of taking a daily tablet on individuals’ HIV risk behaviors, how well patients adhere to the regimen and any possible drug resistance that could emerge among study participants. Results from the iPrEx trial are expected at the end of 2010.

Other PrEP studies are underway in Botswana, Kenya, Malawi, South Africa, Thailand, Uganda, the United States, Zambia and Zimbabwe among different groups of people with increased risk of HIV infection, including MSM, intravenous drug users, female sex workers and heterosexuals at high risk for infection.

iPrEx Medication Receives Generic “OK” On March 30, 2009 the U.S. Food and Drug Administration (FDA) granted tentative approval to a generic version of Truvada manufactured by India’s Matrix Laboratories Ltd. This means that generic Truvada may be used as part of the U.S. government’s PEPFAR program.

If studies show that PrEP works, providing access to drugs that may help reduce HIV infection risk will be a major challenge for advocates, funders, governments and affected communities. Price is just one component of access. Ensuring medication supply and appropriate monitoring are all part of the picture as well. Future issues of Global iPrEx Update will explore these important access issues in more detail.

Stay tuned!

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iPrEx Goes Global

The four original iPrEx sites are located in the Andean region of South America in Peru and Ecuador Asociación Civil Impacta Salud y Educación (Impacta) and Asociación Civil Investigaciones Médicas en Salud (INMENSA) in Lima, Peru; Asociación Civil Selva Amazónica (ACSA) in Iquitos, Peru; and the consortium Fundación Ecuatoriana Equidad/Famivida (Equidad/ Famivida) in Guayaquil, Ecuador.

Each was chosen for their demonstrated expertise with prevention research. These NIHsupported sites were the birthplace and remain the foundation of the iPrEx study.

Now, with additional funding from the Bill & Melinda Gates Foundation, iPrEx is able to welcome our outstanding new study sites:

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Projeto Praça Onze - Federal University of Rio de Janeiro

Fenway Community Health Center, Boston, USA (Investigator,

(Investigator, Mauro Schechter). This study site has extensive experience recruiting cohort studies of MSM with high HIV seroincidence.

Kenneth Mayer). This community-based service and research organization has participated in a wide variety of NIH-sponsored trials. iPrEx has been received with great enthusiasm here.

Fundaçao Oswaldo Cruz FIOCRUZ, Rio de Janeiro, Brazil (Investigator, Jose Pilotto). The site, one of the most prestigious public health organizations in South America, will focus on recruiting men in the city’s periphery.

University of São Paulo - USP, São Paulo, Brazil (Investigator, Esper Kallás) The USP site has successfully conducted HIV vaccine trials in high-risk HIV negative volunteers.

San Francisco Department of Public Health, USA (Investigator, Susan Buchbinder). This site has extensive experience in successfully recruiting for multiple prevention trials, with retention above 90 percent.

Desmond Tutu HIV FoundationUniversity of Cape Town, South Africa (Investigator, Linda-Gail Bekker).

The South African site will provide uniquely valuable information regarding the utility of PrEP among MSM on the continent.

Research Institute for Health Sciences - University of Chiang Mai, Thailand (Investigator, Suwat Chariyalertsak). Serosurveys in MSM here find HIV infection prevalence of 18 percent, comparable to the highest prevalence sites in Latin America. This site will provide valuable information regarding the utility of PrEP among MSM in Asia.

MSM are among the groups most affected by HIV and AIDS worldwide. In low- and middleincome countries in the Americas, Asia and Africa, MSM have a markedly greater risk of being infected with HIV than the general population. In many regions of the world, the denial of basic rights of MSM results in a serious lack of HIV prevention and care services for this community.

From the epidemic’s earliest days, MSM have been on the forefront of efforts to raise awareness of the epidemic and promote greater access to HIV prevention and treatment education and resources for all communities at risk. iPrEx is another way in which MSM are leading in the global response to HIV and AIDS, collaborating with researchers to build awareness of the study and to ensure that volunteers’ rights and information needs are always protected and respected.

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Protecting iPrEx Volunteers

MSM Taking a Lead in HIV Prevention Research

The safety and informed participation of volunteers is a hallmark of the iPrEx study. Potential iPrEx volunteers are extensively interviewed to ensure that they fully understand the study and their rights as participants. Volunteers are counseled that, even if they receive the study medication, there is no assurance it will offer any protection against HIV... meaning safer sex precautions should always be used.

Volunteers are closely monitored for any possible side effects from the study and the study medication is promptly discontinued if any serious concerns are identified. Any volunteer who becomes infected with HIV in the study receives full medical care including HIV treatment if needed.

The participation of affected communities is a cornerstone of iPrEx. Researchers consult regularly with local Community Advisory Boards (CABs), which include leaders of AIDS service organizations, community activists and members of at-risk communities. CAB members have participated in developing the study design, informed consent process and study recruitment strategies, as well as in educating the community about the trial.

Truvada, which was approved by the US FDA in 2004, was selected as the iPrEx study medication because it has been shown to be a safe and effective HIV treatment, with few side effects.

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Boston, USA

Fenway Community Health has been busy educating the community about iPrEx, with an emphasis on reaching out to MSM in communities of color, who are at a particularly high risk for HIV infection. Study recruiters are visiting gay clubs, events and sex areas, and are reaching out to potential volunteers through online venues, which are vital to recruiting a diverse cohort of iPrEx study volunteers.

Iquitos, Peru In Iquitos, ACSA has completed enrollment of 300 study participants, and is now expanding the sample size to 460. “The next great challenge will be retaining participants in the study and ensuring high levels of adherence with the study medication,” noted Martín Casapía, Principal Investigator of the Iquitos site.

Cape Town, South Africa The Desmond Tutu HIV Foundation/University of Cape Town is promoting iPrEx through a toll-free SMS service for information on PrEP and HIV prevention. The team conducts outreach in gay and lesbian bars in the city and LGBT-friendly taverns, known as shebeens, in surrounding townships. PrEP screenings are provided by the Foundation’s mobile HIV voluntary testing and counseling clinic, the Tutu Tester.

San Francisco, USA

PrEP educators in San Francisco have been conducting mass community education on HIV prevention and iPrEx at local events including the Folsom Street and Castro Street Fairs, two of the busiest of the year. San Francisco’s local advertising campaign features the tagline, “Can a pill a day prevent HIV?”

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Lima, Peru

Following extensive community consultation and preparation, iPrEx is well underway in Lima, where the community has been particularly responsive in the face of a growing HIV epidemic among MSM. Support for and participation in the study is strong in Lima, where enrollment is now complete at the two study sites.

Rio de Janeiro, Brazil Following a long regulatory approval process, the Projeto Praça Onze – UFRJ site is now fully activated and enrolling participants, meaning all eleven iPrEx study sites are up and running. FIOCRUZ, another site in Rio de Janeiro, has already enrolled 72 participants since iPrEx began here in October 2008.

Guayaquil, Ecuador Equidad/Famivida has finished enrollment, accruing 300 participants in the city of Guayaquil. “This effort shows strong collaboration among different stakeholders that consider HIV prevention as a priority for their communities” said site Principal Investigator Orlando Montoya.

y d u St s e t i S Chiang Mai, Thailand

Piman Center is a clinic offering services to gay men, male to female transgendered women and other men who have sex with men. iPrEx is being conducted here by the Research Institute for Health Sciences, University of Chiang Mai. The site has enrolled 19 participants since beginning operations in February 2009.

São Paulo, Brazil The site at University of Sao Paulo was activated in mid February of 2009 and had enrolled 25 participants into the study by mid May they. The recruitment team has worked very hard with gay entrepreneurs to promote the study at their venues. iPrEx will be present in the Gay Parade in Sao Paulo, which is expected to draw three million participants from all over the world this year.

A PI’s Perspective Javier Lama MD, MPH Stigma and discrimination against MSM play a large role in driving the epidemic underground in Latin America.

And, as in many regions of the world, MSM in Latin America have been disproportionately affected by both HIV and STIs. MSM have also been central to the response to the epidemic, developing and promoting creative efforts to encourage HIV awareness, condom use and voluntary counseling and testing, and working to educate not only MSM, but also all communities at risk.

Peru also has a long tradition of supporting HIV prevention and cuttingedge biomedical research. With the support of hundreds of volunteers and great community involvement, Peruvian investigators have made enormous contributions to the search for effective strategies to prevent HIV acquisition.

In 2004, we began a dialog with local scientific and community representatives and health authorities to determine whether the Andean region could host a PrEP trial among MSM. Constituents had a lot of questions and some concerns about PrEP. But, following dozens of meetings, consultations and community forums, support for the study has been overwhelming.

The process of building iPrEx in the Andean region has been laborious.

Study design and planning, formal and informal discussions with stakeholders and regulatory bodies and almost a full year of review by Peru’s Ministry of Health all preceded the opening of iPrEx in Lima in June 2007. Encouragingly, the process has continued at a rapid pace since then. To date, 960 volunteers have been enrolled in Lima and more than 390 in the Amazon city of Iquitos. This has been a huge collaborative effort of the iPrEx team and the communities we serve.

While the study nears full enrollment, the central involvement of the MSM community continues. Volunteers must be supported to adhere to their medication and to HIV risk-reduction practices. Our staff consistently counts on the friends and loved ones of our study volunteers to help promote a message of caring for themselves and for others.

We in Peru are proud of the response of our government, NGOs, and our communities to the challenge of HIV, and are grateful for their support of the study and for the wellbeing of communities at risk for HIV. Together, we can defeat this epidemic.

Te Queremos!

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Sponsors and Partners iPrEx is sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) of the US National Institutes of Health (NIH) and co-funded by the Bill & Melinda Gates Foundation. Study medication is donated by Gilead Sciences. This study is under the United States Food and Drug Administration (FDA) investigational new drug (IND) number 71,859.

NIH is sponsoring the iPrEx study through a grant to the J. David Gladstone Institutes, a non-profit independent research organization affiliated with the University of California, San Francisco. The study is being conducted at Asociación Civil Investigaciones Médicas en Salud (INMENSA) and Asociación Civil Impacta Salud y Educación (Impacta) in Lima; and the Asociación Civil Selva Amazónica (ACSA) in Iquitos, all three in Peru; the consortium Fundación Ecuatoriana Equidad/Famivida (Equidad/Famivida) in Guayaquil, Ecuador; Fenway Community Health (Fenway) in Boston and the San Francisco Department of Public Health (SFDPH) in the United States; the Desmond Tutu HIV Foundation-University of Cape Town (DTHF) in South Africa; the University of São Paulo (USP), Projeto Praça OnzeFederal University of Rio de Janeiro (UFRJ) and the Fundaçao Oswaldo Cruz (FIOCRUZ), Rio de Janeiro in Brazil; and the Research Institute of Health Sciences (RIHES) – University of Chiang Mai, Thailand. iPrEx is coordinated by the J. David Gladstone Institute of Virology and Immunology, under the leadership of Protocol Chair Robert Grant, and Protocol Co-Chair Javier Lama, Martin Casapía (ACSA), Juan Vicente Guanira (Impacta), Orlando Montoya (Equidad/Famivida), Susan Buchbinder (SFDPH), Kenneth Mayer (Fenway), Esper Kallás (USP), Mauro Schechcter (UFRJ), Jose Henrique Pilotto (FIOCRUZ), Linda-Gail Bekker (DTHF) and Suwat Chariyalertsak (RIHES).

g n i Com of ssue te: i t x e n a in thel iPrEx Upd ies of a o st r t. The Glob Pill” us

g the ing tr s “Takin and build the hand e n i c . n s s e e t adher of PrEP li articipan p future ouths of utions and m ur contrib e.

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CONTACT US Gladstone Institute of Virology and Immunology 1650 Owens Street, 5th piso San Francisco, CA 94158 United States e-mail: iprex@gladstone.ucsf.edu LIMA • Asociación Civil Impacta Salud y Educación - Impacta Ph: 0800-1-47739 • Asociación Civil Investigaciones Médicas en Salud - INMENSA Ph: 0800 -1-47739 IQUITOS • Asociación Civil Selva Amazónica - ACSA Ph: 0800-1-3231 GUAYAQUIL • Fundación Ecuatoriana Equidad / FAMIVIDA Ph: (593) 239-9264 BOSTON • Fenway Community Health Ph: (617) 927-6440 SAN FRANCISCO • San Francisco Department of Public Health Ph: (415) 554-8888 CAPE TOWN • Desmond Tutu HIV Foundation Institute of Infectious Disease and Molecular Medicine University of Cape Town Ph: 27-(0)21-650-6969 E-mail: MCMHP@hiv-research.org.za RIO DE JANEIRO • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) FIOCRUZ Ph: 0800-28-47739 E-mail: iprex@iprex.com.br • Projeto Praça Onze - UFRJ Hospital Escola Sao Francisco de Assis Ph: 2273-9073

2nd quarter 2009 • Volume 1 Number 1 Published quarterly Visit the Global iPrEx website:

www.globaliprex.net Editors: Mark Aurigemma and Pedro Goicochea Design: Miguel Bernal

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iPrEx UPDATE • 2ND QUARTER 2009 • VOLUME 1 NUMBER 1

SAO PAULO • Universidade de Sao Paulo Ph: (11) 2778-3040 Ph: (11) 3717-2432 CHIANG MAI • Research Institute for Health Sciences Ph: 053 - 211362 - 3 E-mail: MSM@rihes.org