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Research - Overview: National AIDS Strategy

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"Our common goal must ultimately be a cure, a cure for all those who are living with HIV, and a vaccine to protect us from the virus."

President Clinton, December 5, 1996
The White House Conference on

Record of Accomplishment

Since 1981, the nation has made significant advances in HIV-related research including:

  • Identification of HIV as the etiologic agent for AIDS;
  • Development of a reliable test to determine exposure to HIV;
  • Determination by NIH of the three-dimensional structure of reverse transcriptase, providing the target for the use of AZT as the first antiretroviral drug proven effective against HIV in NIH-supported clinical trials;
  • Approval of AZT, the first treatment for HIV primary infection; and
  • Development by the Food and Drug Administration (FDA) of a system of expedited review[5] of treatments for life-threatening diseases, including HIV.

Since he took office in 1993, President Clinton has advanced AIDS research efforts by:

  • Increasing AIDS research funding at NIH by 40 percent;
  • Signing the NIH Revitalization Act of 1993, providing the Office of AIDS Research at NIH new authority to develop and implement an annual AIDS research plan and budget;
  • Accelerating AIDS drug approval by the FDA to record times;
  • Approving 16 new HIV-related drugs, 8 new indications, and three new diagnostics for HIV and related conditions, developed through public and private sector development efforts, by the FDA since January 1993;
  • Supporting research that led to the finding that use of AZT during pregnancy, childbirth, and the first six weeks of life can reduce the transmission of HIV from mother to child by two-thirds;
  • Approving in record time a promising new class of AIDS drugs known as protease inhibitors;
  • Launching a four-year, $100 million research effort to develop effective topical microbicides;
  • Developing the first Federal Plan for Biomedical Research on HIV and AIDS to improve coordination of HIV-related research; and
  • Facilitating creation of the Forum for Collaborative HIV Research to identify opportunities for clinical effectiveness research to improve care for HIV-positive individuals.

Contributions of AIDS Research
to Understanding of Other Diseases

AIDS research has provided significant benefits in the fight against many other diseases. AIDS research has accelerated study of the human immune system, helping to better understand and treat such diseases as cancer; autoimmune diseases, including systemic lupus erythematosus; type I diabetes mellitus; rheumatoid arthritis; and multiple sclerosis. AIDS research advances have also contributed to the prevention and treatment of other infectious diseases and provided a new paradigm for treatment of viral diseases.

Progress in the treatment and prevention of HIV-related opportunistic infections has had an enormous impact on the care of patients with other immunodeficiency conditions who are susceptible to many of the same pathogens. This research effort has enhanced the care of cancer patients, patients who have received immunosuppressive therapy for transplants, and the treatment of diseases caused by elevated immune responses (e.g., allergies and lupus).

HIV research has assisted in identifying new infectious agents that may be responsible for malignancies, such as the recent discovery of the etiologic agent for Kaposi's sarcoma. These findings may help to identify other oncogenic agents. HIV research has led to a better understanding of the mechanisms by which infectious agents and inflammatory cells cross the blood/brain barrier, providing valuable clues for research on Alzheimer's disease, dementia, multiple sclerosis, neuropsychological disorders, encephalitis, and meningitis. Studies to develop anti-HIV therapies have improved our understanding of additional viral diseases and led to development of treatments.

Efforts to develop drugs for the treatment of HIV have accelerated the development of methods of targeted drug design using sophisticated techniques of structural biology and advanced computer imaging methods. These advances have implications for drug design for virtually all disorders. Clinical trials of poxvirus vaccine vectors and adjuvants in HIV vaccine candidates have supported safety information for cancer vaccines. Research on HIV-related wasting has provided important information for research on nutritional disorders, metabolic abnormalities, and gastrointestinal dysfunctions.

Future Opportunities for Progress

While tremendous progress has been made in HIV research, we cannot and will not diminish our effort until we have found a cure and a preventive vaccine. To accomplish this national goal, we must address four ongoing challenges:

  • Provide leadership and coordination for the Federal research effort;
  • Develop biomedical interventions that prevent HIV infection, including both vaccines and microbicides;
  • Develop new and more effective therapies for HIV and related conditions; and
  • Assure adequate funding for this research effort.


Leadership and Coordination of Research

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


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.
Developing New and More Effective Therapies

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.
Support for Research

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.




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