Women's Interagency HIV Study Begins.

Date: June 28, 1993
Source: Department of Health and Human Services (DHHS)

HHS Secretary Donna E. Shalala announced today that the National Institute of Allergy and Infectious Diseases has awarded $5 million to four new sites participating in a large-scale study to investigate the impact of human immunodeficiency virus infection on women in the United States. HIV is the cause of the acquired immune deficiency syndrome.

The four-year project, called the Women's Interagency HIV Study, will study the signs and symptoms of HIV infection in women, describe the pattern and rate of their immune system decline and examine potential co-factors that may affect their HIV disease progression. The study also will provide information on the effect of therapies on the length of survival and quality of life for HIV-infected women.

AIDS is now the sixth leading cause of death for women aged 25 to 44 in the United States," said Secretary Shalala. "NIAID has worked together with other Public Health Service agencies to establish this large-scale study that promises to yield critical information on HIV disease in women, including the gynecological manifestations of the disease."

The four new WIHS sites and their principal investigators are:

  • Bronx-Lebanon Hospital Center, New York City, Kathryn Anastos, M.D.
  • University of California at San Francisco, Ruth Greenblatt, M.D.
  • University of Southern California, Los Angeles, Alexandra Levine, M.D.
  • Georgetown University, Washington, D.C., Mary Young, M.D.
Anthony S. Fauci, M.D., NIAID director, said, "The Women's Interagency HIV Study promises to add to our understanding of the clinical, immunological, virological and behavioral aspects of HIV disease in women. This knowledge is vital to the design of research projects and clinical trials to evaluate better treatment strategies. Because the study also includes women at high risk for HIV infection, we will also learn more about the risk factors for infection and the effectiveness of initiatives to prevent HIV infection in women."

Study investigators will gather information from approximately 1,700 HIV-infected women and 375 women not infected with HIV but at high risk of acquiring the infection. Participants will visit the study sites at six-month intervals, where they will be given a physical examination, including a comprehensive pelvic exam, and participate in a multi- disciplinary, structured interview. The researchers also will take laboratory specimens to precisely measure participants' immune status and identify conditions such as the development of cervical abnormalities and sexually transmitted infections.

The new sites augment an earlier phase of the project, called the HIV Epidemiology Research Study, initiated in 1992 and sponsored by the Centers for Disease Control and Prevention and NIAID. The HIV Epidemiology Research Study sites include Wayne State Medical Center, Detroit, Mich.; Brown University, Providence, R.I.; Montefiore Medical Center, New York, N.Y.; and The Johns Hopkins University, Baltimore, Md. In April, 1993, that study began enrolling approximately 800 HIV-infected women and 400 women not infected with HIV but at high risk for acquiring the infection.

NIAID also supports a statistical and clinical coordinating center to serve the data management and analysis needs of both projects. In FY 1993, NIAID support for the two studies and the data center will total an estimated $6.7 million.

The number of AIDS cases in women has increased rapidly in the last few years. As of March 31, 1993, 11.4 percent (32,477) of the 284,840 U.S. AIDS cases in people older than age 13 were among women, according to CDC.

The study of HIV infection in women is a major research focus of NIAID. The institute supports studies of the natural history, symptoms and transmission of HIV in women in the United States and 11 other countries. NIAID also supports three AIDS clinical trials networks, and an intramural research program on the NIH campus, to assess therapies for HIV infection and related infections.

NIAID, a component of the National Institutes of Health, supports research on AIDS and other infectious diseases, allergy and immunology. NIH is an agency of the Public Health Service within HHS.

For press inquiries only, please call Greg Folkers at (301) 402-1663.