Developing and implementing the Federal government's AIDS research agenda presents both scientific and logistical challenges that require leadership, coordination, and strategic planning, first among the 24 institutes, centers, and divisions of the NIH, and second among the various Departments and Agencies throughout the government that support HIV research.

The strengthened authority and new leadership of the NIH Office of AIDS Research and the first Federal Biomedical and Behavioral Research Plan and Budget for HIV and AIDS form the basis for better coordination of our research effort and provide the assurance that key questions are being answered systematically and without duplication. Over the next year, the Clinton Administration is committed to the reauthorization of the OAR's authority and assuring that its budget powers are maintained throughout the appropriations process.

As part of the ongoing commitment to assess all aspects of our research effort, the OAR convened a panel of outside experts to evaluate NIH's AIDS research programs. The Report of the NIH AIDS Research Program Evaluation Task Force, chaired by Dr. Arnold Levine, included several key recommendations that will be implemented in the year ahead. These include:

• Increase NIH support for basic science through investigator-initiated research;
• Establish a restructured trans-NIH vaccine research effort;
• Augment research efforts to better understand the human immune system;
• Develop a comprehensive NIH HIV prevention science agenda, combining biomedical, behavioral, and social interventions; and
• Improve coordination among all NIH-supported AIDS clinical trials programs.

Biomedical Prevention of HIV Infection

Vaccine
Development

The scientific community continues to strive for an effective vaccine against HIV infection. The Federal government, through the NIH and the Department of Defense, continues to support two approaches to vaccine development. The first approach is based on the belief that gathering additional basic science information offers the best hope in steering vaccine development and that many critical questions must be answered before human trials should begin. The second approach is guided by the belief that data gathered from clinical efficacy trials of vaccine candidates in humans can lead to the development of a successful candidate and that if a safe candidate is available, it is not necessary to resolve all of the scientific questions before proceeding with human trials. Both approaches will continue to be pursued on a parallel and interrelated path. Trials of more complex vaccine products and two types of vaccine candidates have been underway for several years, and larger trials are planned for the near future.

The development of safe and effective mechanical or chemical barrier methods that will block HIV transmission or prevent other sexually transmitted infections could dramatically reduce the sexual transmission of HIV. Worldwide, more than 70 percent of HIV infections are acquired heterosexually and women are more easily infected than men. Moreover, the risk of becoming infected or infecting others is substantially increased by the presence of other STDs.[6]

Latex condoms are the most effective barrier methods currently available but still have limitations. Most require the consent of both partners and therefore cannot be independently used at the discretion of one partner. An easily available and inexpensive microbicide could provide a prevention option for millions of people worldwide.

To address these goals, the following steps will be taken:

• During FY 1997, NIH and CDC will begin to implement a four-year, $100 million initiative on microbicides announced by HHS Secretary Shalala at the Eleventh International Conference on AIDS;
• The Vice President will continue a high-level dialogue designed to encourage private sector involvement in the development of both microbicides and vaccines; and
• Through U.S. participation in UNAIDS, and in other forums, we will encourage international efforts to develop effective microbicides.

Another challenge in the research arena is developing new and more effective therapies that may allow us to transform HIV disease into a chronic manageable condition. While the FDA is approving new treatments in record numbers and at record speed, the long-term clinical effectiveness of these new therapies remains unknown. There is no doubt that new drugs must be developed. To accomplish this, NIH will spend an estimated $470 million in the area of therapeutic research in FY 1997. In addition, several other initiatives will be undertaken or maintained:

• Federal support for the Forum for Collaborative HIV Research will promote public-private collaboration in AIDS research. This new group, formed at the behest of Vice President Gore, is designed to catalyze collaborations among government researchers, pharmaceutical companies, third-party payors, and the community to capitalize on recent scientific advances and learn how to optimally use available treatment regimens. The Federal government is committed to being an equal partner in this new effort.
• A Federal commitment to continued access to sophisticated equipment and personnel that can be shared among researchers in both the private and public sectors. The Department of Energy (DOE) has made available the use of sophisticated imaging equipment that would otherwise be prohibitively expensive for individual researchers or companies. This shared resource has accelerated the understanding of molecular structures in a number of research fields, including HIV. Information gained from this research can form the basis for targeted drug design and development.
• Increased focus in Federal research on vulnerable populations. Our research effort will increase its focus on the needs of vulnerable populations, including adolescents, children, women, minorities, and substance abusers. The efforts of programs such as the Women's Interagency HIV Study (WIHS), the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), and the Adolescent Medicine HIV/AIDS Research Network are important to improving our understanding of HIV disease in these populations and will continue.

HIV research is an investment in our future. Already, it has helped prolong and improve the quality of lives of HIV-infected individuals, and we must continue to make this investment. Moreover, the U.S. commitment to research has both a domestic and international impact. Support of research programs will not only serve to slow the epidemic here at home, but also has the potential to slow the international pandemic. Unleashing the talents of the best and the brightest in finding a cure, better therapies, and a vaccine will require a sustained funding commitment in order to meet the research challenges. NIH currently receives many more outstanding research applications than it is able to fund -- representing a lost opportunity for scientific progress. Other Agencies, such as DOD, CDC, and VA, also support crucially important HIV research that strengthens the overall U.S. research effort. Recognizing the importance of biomedical research generally and AIDS research specifically, the FY 1997 research budget for NIH was increased by $820 million overall, and AIDS-specific research received a $94 million increase.