Clinical Trial :: NIH names Clinical Trial Units for the Microbicide Trials Network

Twelve institutions today were named by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), as HIV/AIDS clinical trial units (CTUs) for the Microbicide Trials Network (MTN), a new HIV/AIDS clinical trials network established by NIAID last year.

The CTUs, located in Africa, India and the United States, will engage in multi-center studies spanning 17 locations in seven countries that seek to determine if topical microbicides can help prevent the sexual transmission of HIV in women.

Nearly half of the 39.5 million people living with HIV/AIDS are women, and in Africa, women account for 59 percent of all infected adults. Young women are especially vulnerable. For instance, in sub-Saharan Africa, those aged 15 to 24 with HIV outnumber men of the same age by three to one.

In developing countries, HIV most often is spread through unprotected heterosexual intercourse, and educational efforts promoting abstinence, monogamy, and condoms have not been completely effective. Through its CTUs, the MTN is evaluating the potential that microbicides, substances formulated as gels or creams, for example, can reduce or prevent the sexual transmission of HIV and other sexually transmitted diseases when applied topically to the surface of the vagina.

The MTN CTUs based outside the United States are the National AIDS Research Institute in Pune, India; the Medical Research Council in Durban, South Africa; and the University of Cape Town, South Africa. U.S. institutions named as CTUs that will be conducting MTN trials exclusively at the international sites with whom they collaborate are the University of California, San Francisco, which operates in Zimbabwe, and Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine, both in Baltimore, with affiliations in Malawi and Uganda, respectively. The University of Alabama at Birmingham, was granted two CTU awards, one for its international site in Zambia, and the second for its U.S. site.

The remaining CTUs, all U.S.-based, are Case Western Reserve University in Cleveland; Columbia University in New York City, the University of Pittsburgh; and the University of Pennsylvania, Philadelphia.

Each of these CTUs has affiliated clinical research sites that will conduct the actual trials, some within the same city or institution and others at additional locations in the same country or region. Accounting for those CTUs with more than one clinical research site, the MTN will be conducting trials at 17 locations in five African countries, the United States and India.

The MTN’s clinical research sites are located in Pune, India; Llongwe, Malawi (two sites); Durban, South Africa (four sites); Cape Town, South Africa; Kampala, Uganda; Harare, Zimbabwe (two sites); and Lusaka, Zambia; as well as in New York, Cleveland, Pittsburgh, Philadelphia and Birmingham, Ala.

To face the global urgency of the HIV/AIDS epidemic head-on, the MTN anticipates conducting 17 scientifically rigorous and ethically sound clinical trials over the next seven years. Some of these trials will be designed to evaluate microbicides along with other promising HIV/AIDS prevention approaches, such as oral anti-retroviral prophylaxis.

“The scope of the crisis requires an aggressive agenda in which the clinical trial units and clinical research sites play an essential role. By virtue of being selected by NIH, our CTUs have proved themselves as the most qualified and the most committed to take part in an endeavor of such great global importance,” said Sharon Hillier, Ph.D., MTN principal investigator and professor of obstetrics, gynecology and reproductive sciences and of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine and director of reproductive infectious disease research at the Magee-Womens Research Institute.

The MTN brings together international investigators and community partners who are devoted to reducing the sexual transmission of HIV through the development and evaluation of microbicides and who work within a unique infrastructure designed to conduct research that will support licensure of topical microbicide products for widespread use.

Based at the University of Pittsburgh and Magee-Womens Research Institute, MTN’s core operations are supported by a central laboratory at the University of Pittsburgh, a statistical and data management center housed within the Statistical Center for HIV/AIDS Research & Prevention at the Fred Hutchinson Cancer Research Center, and Family Health International, a global organization with expertise conducting clinical protocols. It receives funding from three NIH institutes: NIAID, the National Institute of Mental Health and the National Institute of Child Health and Human Development.

MTN’s 12 CTUs are among the 60 U.S. and international institutions that recently received awards from the NIAID; NIAID expects to fund a total of 73 CTUs with approximately 145 clinical research sites within the next several months. Each CTU and clinical research site will work with one or more of six NIAID HIV/AIDS clinical trials networks. In addition to the MTN, they include the AIDS Clinical Trials Group, the HIV Prevention Trials Network, the HIV Vaccine Trials Network, the International Maternal Pediatric Adolescent AIDS Clinical Trials Network and the International Network for Strategic Initiatives in Global HIV Trials.

Leave a Comment