Recent Projects

A summary of selected DF/Net Research projects is presented below:

International Partnership for Microbicides (IPM)

DF/Net has been working with IPM since 2007 on over sixteen microbicide studies, including the current large-scale IPM 027 clinical trial, The Ring Study. The Ring Study is designed to determine whether a monthly vaginal ring that delivers the ARV drug dapivirine helps prevent HIV infection in women and is safe for long-term use. The first efficacy study of a vaginal ring for HIV prevention, The Ring Study is expected to enroll 1,650 women ages 18-45 across four sites in South Africa over the coming months.

IPM’s mission is to prevent HIV transmission by accelerating the development and availability of safe and effective microbicides for use by women in developing countries. IPM is dedicated to providing women with affordable and self-initiated HIV-prevention strategies they can use to protect their own health. Founded in 2002 as a product development partnership, IPM has become an important partner in the microbicide field.

IPM also engages and collaborates with advocates and global health leaders to raise awareness about microbicides and  other HIV prevention products worldwide. Through their working partnerships at the local and national level in developing countries, IPM has helped build health research infrastructure in parts of the world where the need for health research is greatest.

For more information on IPM and their important global research, please refer to their web site at:

http://www.ipmglobal.org/

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Infectious Disease Research Institute (IDRI)

DF/Net has been working with IDRI on Leishmaniasis vaccine studies since 2006. Leishmaniasis is a parasitic disease that occurs in 88 countries around the world. It has an estimated annual incidence of two million cases and a prevalence of 12 million cases. Visceral leishmaniasis, the most severe form of the disease, affects vital organs and has a high fatality rate if not treated. Cutaneous leishmaniasis, the most common form of the disease, causes serious skin lesions and often leaves its victims permanently disfigured. Drugs to treat leishmaniasis are expensive, toxic, or impractical.

IDRI is actively developing vaccines for human and canine leishmaniasis. The human vaccine is being evaluated for prophylactic and therapeutic indications in clinical trials in South America, India and Sudan. The canine vaccine is being tested in Brazil, where dogs are an important source of human infection. To date, these studies have shown that the vaccines are safe, well tolerated, immunogenic, and potentially efficacious in the prevention and treatment of diverse forms of leishmaniasis.

DF/Net has provided data management for IDRI’s vaccine programs in Colombia, Venezuela, Brazil, Peru, Sudan, and India, as well as its flu program more close to home in Texas, Florida, and Wisconsin.

Jill Ashman, Associate Director Clinical Operations for IDRI said of DF/Net:

“The team at DF/Net are a pleasure to work with. They provide excellent service and are always quick to respond.  Conducting studies on four continents, often in remote settings, is a challenge and DF/Net has been able to help IDRI with solutions that work. The ability to connect to their system using iDataFax and view study data in real time is crucial to our research.”

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iPrEx OLE Study: Gladstone Institute

iPrEx OLE Study: Gladstone Institute

After the success of iPrEx, DF/Net continued working with the Gladstone Institute, providing the data management for iPrEx OLE. iPrEx OLE (Open Label Extension) is a continuation of the iPrEx study designed to provide additional information about the safety of PrEP and the behavior of people taking PrEP over a longer term. It is hoped that participants’ knowledge that Truvada PrEP provides some protection against HIV infection, and the fact that all HIV-negative participants in iPrEx OLE know that they are receiving Truvada PrEP and not a placebo, will lead to increased use of the study drug by participants in iPrEx OLE, and increased protection against HIV infection.

iPrEx OLE started enrollment on June 13th, 2011 at the San Francisco Department of Public Health and closed enrollment in July of 2012 at Investigaciones Medicas en Salud in Lima, Peru. A total of 1,770 participants enrolled in iPrEx OLE at 11 sites in six countries. Results from this open label extension phase of the study are expected by the first quarter of 2014.

The 11 participating sites for this study are located in Peru, Ecuador, Brazil, the United States, South Africa and Thailand.

For more information on iPrEx OLE, please refer to their web site at:

http://www.iprexole.com/index.html

 

 

 

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iPrEx Study: Gladstone Institute

iPrEx Study: Gladstone Institute

The Chemoprophylaxis for HIV Prevention in Men study, also known as iPrEx, is a Phase III clinical study designed to determine whether a daily tablet containing a combination of two antiretroviral drugs used for HIV treatment can safely and effectively prevent HIV infection among men who have sex with men and transgendered women who have sex with men. The iPrEx study, which began in July 2007, was the first large-scale study under the National Institute of Allergy and Infectious Diseases (NIAID) to investigate the now widely-accepted HIV prevention approach known as pre-exposure prophylaxis, or PrEP.

The randomized, double-blind, placebo-controlled trial enrolled 2,499 men and transgendered women at 11 sites in nine cities in Brazil, Ecuador, Peru, South Africa, Thailand and the United States.

DF/Net has been working with Dr. Grant’s team at Gladstone since 2006.

For more information on iPrEx OLE, please refer to their web site at:

http://www.iprexole.com/index.html

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