"The availability of microbicides would greatly empower women to protect themselves and their partners.   Unlike male or female condoms, microbicides are a potential preventive option that women can easily control and do not require the cooperation, consent or even knowledge of their power."   
World Health Organization

If you have any questions please feel free to contact us at 216-844-AIDS or via email at antosh.dawn@clevelandactu.org
For information on the 1st Microbicide Trial Open in Cleveland, click here.

  Micro What?

Microbicide means any substance that will kill a microbe (such as a virus).  An HIV microbicide refers to a topical treatment in the form of a gel, foam or cream that could decrease or prevent sexual transmission of HIV.  As  HIV continues to spread  throughout the world, the search for an effective, safe, affordable HIV microbicide continues to increase in importance.

Who We Are.

   The AIDS Clinical Trials Unit at Case Western Reserve University/University Hospital has been offering HIV/AIDS-related clinical trials to Greater Clevelanders since 1987 as part of the federally-funded AIDS Clinical Trials Group.  In 2007, the AIDS Clinical Trials Unit joined the newly formed Microbicide Trials Network, established by the federal National Institutes of Health to spur the development of safe, effective and affordable HIV microbicides.   In July 2008 the AIDS Clinical Trials Unit opened its first microbicide trial in Cleveland, named MTN001.           

Vaginal and Rectal Microbicides

The search for effective, safe and affordable HIV microbicides includes the development and clinical testing of HIV microbicides to be used for vaginal and anal sex.  While much of the current efforts are directed toward the development of vaginal microbicides, the Microbicide Trials Network is actively involved in rectal microbicide development and clinical trials.  Extensive information on rectal microbicides can be found at the IRMA (International Rectal Microbicides Advocates) website.  

 

 

 

 

Would you like to get periodic information about microbicide and other prevention trials 
in Greater Cleveland? Call Bob Bucklew at 216-844-2247 or via email rob2@case.edu 

If you are HIV-negative between the ages of 18-60 click here to sign up 
for our HIV-negative volunteer database.

For more information, click on the links below: 

The Need for New HIV Prevention Methods

What is a microbicide?

Pre-exposure Prophylaxis

Safeguards for Clinical Research Trial Participants

 

 

                                    

The Need for New HIV Prevention Methods: Around the World and in Northeast Ohio

As the global AIDS epidemic grows close to completing its third decade, there have been many medical advances in the treatment of HIV-positive people.  The introduction of antiretroviral therapy in the 1990s has drastically altered the prognosis of an HIV infection diagnosis.  Clinical trials, such as those offered at the CWRU/UH AIDS Clinical Trials Unit, of new medicines and methods of treating HIV-related complications continue to provide new tools to help extend and improve the quality of life for many HIV-positive people.   

The medical advances, as important as they are, however, are not a cure.  People must stay on these complicated medicines for the rest of their lives. Complications from taking the medicines for an extended period of time continue to arise.   Additionally, these medical treatments cost a great deal, making them out of reach of many in the developing world.  Despite medical advances 2.1 million people died of AIDS in 2007.   It is imperative that new biomedical tools be created to keep people from becoming infected.   This is particularly true for women, who often have little control over protecting themselves from HIV infection. 

According to the Joint United Nations Joint Program on HIV/AIDS (UNAIDS), in 2007, 6,800 people become newly infected with HIV every day, while 5,700 people die of AIDS each day.  At the end of 2007 over 33 million people were living with HIV.   Half of the HIV-infected adults were women.  In Sub-Saharan Africa, the region most impacted by the AIDS epidemic, almost 61% of the people living with HIV/AIDS were women.  2007 AIDS Epidemic Update (pdf: 1.64 MB)  HIV infections continue to increase in Northeast Ohio also.  At the end of 2007, 3,744 people in Cuyahoga County were living with HIV/AIDS.  Of this number 24% were female.  

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What is a microbicide?

Microbicides are substances designed to prevent or reduce the sexual transmission of HIV when applied topically on the inside of the vagina or rectum. A microbicide can be formulated in many ways, such as a gel or cream, or as a ring that would release the active ingredient over time. Some microbicides are also being developed for rectal use.  Several microbicide products are being tested in clinical trials, including trials conducted by the MTN, although none is currently approved or available for use.

 

Pre-exposure Prophylaxis

In addition to testing microbicides, it is also possible that some of the clinical research trials will include pre-exposure prophylaxis, commonly referred to as PrEP.  PrEP is an HIV-prevention strategy whereby prior to sexual activity HIV-negative people would take antiretroviral drugs - drugs taken by people who are HIV-positive - to protect themselves from HIV-infection.  At this time, PrEP has not been proven to work; it is a strategy that is currently being tested.   For more information on PrEP, click here.

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Safeguards for Clinical Research Trial Participants

The safety of all clinical research trial participants is paramount at the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit.  Every clinical research study is designed according to the most rigorous international ethical standards and with the greatest concern for participant safety.   Prior to enrolling in a research clinical study, each participant undergoes a detailed informed consent process, ensuring that she or he understands the procedures, risks and benefits of the study, and that they are not obliged to participate and may leave the study, without consequence, at any time.  

During the trial’s conduct, every possible measure is taken to protect the wellbeing of study participants. Strict national and international procedures for safety monitoring and reporting are followed, including regular reviews by a Protocol Safety Review Team and/or an independent Data and Safety Monitoring Board. 

In addition to Network monitoring, all clinical trials are reviewed by the University Hospitals Institutional Review Board.   The AIDS Clinical Trials Unit's Community Advisory Board (CAB) also serves an important role in monitoring and offering advise on current and future clinical research trials.  A separate committee of the oversees microbicide and other biomedical HIV prevention clinical research trials.  If you are interested in volunteering for the CAB Microbicide Committee, additional information may be obtained by clicking here. 

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