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Animal Models

The objective of these studies is to continue to develop animal models of AIDS

in which candidate vaccines and drugs can be tested.

0 Studies of naturally occurring animal retrovirus infections simulating AIDS, such as Simian AIDS.

Outreach

Studies on the transmission of HTLV-III from humans to nonhuman
primates. These projects will attempt to establish a reproducible
means to induce clinical manifestations of AIDS in nonhuman primates,
in order to develop a better animal model for the disease. Such a
model promises to provide investigators with means to assess the
natural history of AIDS and evaluate a variety of interventive
measures for the treatment or prophylaxis of human AIDS. Another
aspect of these studies will be to mate infected or seropositive
animals and study their offspring to further investigate
maternal-fetal transmission of HTLV-III. Additionally, serial passage
of HTLV-III will be made in chimpanzees, paralleling comparable

studies of natural infections in man, to determine if antigenic drift
occurs, an important factor in vaccine development.

Information programs have been designed to promote a fuller understanding of AIDS and to disseminate the latest research advances to those involved in the care of AIDS patients. For example:

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A series of workshops, seminars, conferences, and outreach education programs aimed at different populations, including physicians, health care workers, allied service personnel dealing with AIDS patients, and lay individuals. As an example, NIAID has developed an outreach education program specifically designed for health workers and allied support personnel who care for AIDS patients. These conferences have

been held in a number of U.S. cities, and the program will continue. The purpose of the conferences is to provide the most recent

information and to dispel myths and fallacies regarding AIDS. One of the major thrusts of this effort is discussion of the known facts and fallacies associated with modes of transmission and protection, and the currently accepted guidelines for the proper management of patients with AIDS. NIAID also plans to develop workshops on AIDS for presentation at national professional and lay organization meetings.

Current support by National Heart, Lung and Blood Institute to identify the most effective methods to inform and counsel blood donors who are identified as HTLV-III antibody positive will continue. Future activities in this area may include consensus development conferences on appropriate methods to counsel blood transfusion recipients, hemophiliacs, persons with sickle-cell disease or Cooley's anemia, and bone marrow recipients regarding their health status and lifestyle after exposure to HTLV-III.

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Use of the Physician's Data Query (PDQ) system developed by NCI as a means of providing physicians with information about standard and experimental treatment of cancer, locations of experimental treatment, and the names of cancer specialists. To respond to the AIDS crisis and make the most recent information on AIDS available to health practitioners, NCI has included information on ongoing AIDS studies in the PDQ system.

Provision of information support by the National Library of Medicine (NLM) through bibliographic and reference services. NLM is producing a comprehensive bibliography on AIDS, which will be available both to the Department and to extramural AIDS investigators.

Summary

Mr. Chairman, I believe I have provided the Committee with an overview of NIH activities that demonstrate our major commitment toward developing treatments, a vaccine, and ultimately a cure for AIDS. The fast pace of AIDS research at NIH and in the numerous research institutions in this country and around the world, makes almost any research planning effort dated before it is complete. NIH research efforts directed toward the AIDS problem are both logical and comprehensive. Our efforts, fully coordinated with other agencies of the PHS,

are broad and multifaceted, since no one can predict which approach will ultimately be successful. We all hope for new findings in this area, and are prepared to apply those results to our research effort upon discovery.

This concludes my prepared statement. I will be pleased to answer any questions you may have.

STATEMENT OF DR. DONALD R. HOPKINS

Mr. Chairman and members of the Subcommittee, I am Dr. Donald Hopkins, Acting Director of the Centers for Disease Control. I am pleased to appear before you today to discuss CDC's activities in Acquired Immune Deficiency Syndrome (AIDS) prevention and control during FY 1985 and our proposed activities in FY 1986.

When clusters of a rare cancer, Kaposi's sarcoma, and Pneumocystis carinii pneumonia were first recognized in homosexual men in 1981, CDC took a lead

role in investigating these disturbing phenomena. As a result of early epidemiologic investigations, and in an effort to standardize reporting, a case definition was developed for what was to become known as AIDS. A nationwide surveillance program was established to monitor trends as the epidemic progressed, and specialized epidemiologic studies were initiated to investigate modes of transmission and to identify those factors and groups associated with increased risk for developing AIDS. CDC also joined in the laboratory search for the agent causing the disease.

Surveillance studies showed very early that AIDS was spreading rapidly in certain populations and that the disease would soon become a major public

health concern. One important surveillance tool early in the AIDS epidemic was an increasing demand on the CDC drug service program for distribution of pentamidine isothionate, a drug used in the treatment of Pneumocystis carinii pneumonia. Pneumocystis is an infection most commonly seen in immuno-compromised patients. CDC had started distribution of pentamidine isothionate to treat Pneumocystis under an Investigational New Drug (IND) license in 1967. An increase in requests for this drug was noted in 1981 and by 1984 more than 350 patient doses were distributed each month, a clear indication of the increasing number of AIDS cases in this country. increasing demand for this drug to treat AIDS patients, CDC and the FDA actively sought a U.S. producer and possible distributor for pentamidine in 1983. In November 1984, CDC discontinued distribution of pentamidine after the drug became commercially available.

Because of

Epidemiologic studies and investigations into individual cases by CDC defined certain populations at high risk for AIDS. These included sexually active homosexual and bisexual males, IV drug abusers, and recipents of blood and blood products, (especially patients with hemophilia). These findings strongly suggested that a bloodborne agent, probably a vírus, was responsible for the disease. Laboratory studies identified imbalances in patients' systems, indicating that the white blood cells, responsible for defending the body against the disease, were being destroyed.

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In order to speed research into this new disease, CDC became a major center for disseminating information. Through 64 articles thus far in its weekly publication, the Morbidity and Mortality Weekly Report, scientists around the world have been kept abreast of the latest developments in the field. CDC continues to be a major collaborating center for additional

research.

Controlling the spread of AIDS also required assertive action at the State and local levels. Therefore, CDC collaborated with State and local health departments and other community groups whose organized participation was essential for success. Much of CDC's resources to date have been directed toward those States and communities with the highest incidence of AIDS. Collaborative efforts have been designed to enhance communitywide surveillance for AIDS, to protect the Nation's blood supply through the provision of

alternate test sites, and to stimulate health education and risk reduction activities. We have also worked closely with a number of States and communities on epidemiologic research to answer some of the fundamental questions that currently constrain our mutual efforts to understand AIDS, clearly explain it to an increasingly concerned public, and begin to effect its control. In FY 1986, CDC will expand its cooperative relationship with State and local health departments and other community organizations on a broad national scale by providing the funds, the training, and the technical assistance to augment our mutual efforts to control the spread of HTLV-III

virus.

During FY 1985, CDC has expanded AIDS surveillance, epidemiologic studies, and laboratory investigations, and has initiated major health education and risk reduction activities. Our total appropriation in FY 1985 for these activities, which I will discuss in more detail below, has been $33.2 million. Surveillance

National surveillance of AIDS has been maintained and upgraded through mathematical modeling of current and future trends. The completeness of case reporting is being verified in several States and cities, and patients surviving over 3 years are being epidemiologically characterized. Special microcomputer software has been developed for use by State and local health agencies to assist in the analysis of AIDS surveillance information and to expedite reporting to CDC.

Cooperative agreements are providing financial and

technical assistance to 23 State and major city health departments for active

AIDS surveillance.

Epidemiologic Studies

Current epidemiologic studies include investigation of blood donors in transfusion acquired AIDS cases, study of families of hemophiliacs and other AIDS victims, intensive investigation of patients outside the usual high risk groups, studies of transmission in Central Africa, and studies of health care workers who have had inadvertent needle stick injuries. One of these studies is following a cohort of 7,000 homosexual men in San Francisco to determine incidence, risk factors, and natural history of AIDS disease and infection. Another study is focusing on individuals transfused with blood from persons who later developed AIDS or AIDS-related conditions. We are performing a

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