Important note: Information in this article was accurate in 2004. The state of the art may have changed since the publication date.
Food and Drug Administration - December 1, 2004
From the first, isolated reports in 1981, AIDS has grown into a global pandemic. It affects every corner of the world. Despite efforts in every nation, the epidemic continues to grow.
Today the face of AIDS is increasingly young and female. Globally, women account for nearly half the adults living with HIV. The official theme of World AIDS Day this year is Women and Girls and HIV/AIDS, intending to help focus attention and resources on increasing access to prevention and treatment services for women.
In the United States and other industrialized nations, potent antiviral drugs have dramatically helped people with HIV and AIDS live longer, healthier lives.
FDA has played a strong role in addressing treatment and prevention from the beginning of the epidemic, including the approval of improved medical treatments, providing access to promising investigational products, helping to prevent the transmission of HIV through regulation of barrier products, protection of the blood supply, and oversight of the development of vaccines (both preventive and therapeutic) and microbicides.
World AIDS Day commemorates those that have died from AIDS. It also serves as an opportunity to think about how we can help support the individuals, families, and communities affected by HIV and AIDS, and to renew our commitment to preventing the spread of the disease, developing and delivering more effective treatments, and finding a cure.
You can find a comprehensive chronology of significant events in FDA's involvement in the fight against HIV on the FDA website at
http://www.fda.gov/oashi/aids/miles.html
1981-1990: This decade saw the first report of AIDS and its identification as a retrovirus, approval of the first immunoassay test, approval of the first drug to treat AIDS (AZT), the first drugs for treatment and prevention of certain opportunistic infections, and a mechanism for expanded access to promising therapies prior to approval.
1991-1994: These years saw the creation of the National Task Force on AIDS Drug Development , large-scale expanded access to pre-approved HIV therapies, and approval of a number of new drugs. Accelerated approval permitted earlier approval of therapies based on surrogate marker activity. The first non blood-based collection system was approved to test for HIV, and a female condom was approved, providing women with a barrier product that didn't rely on a woman's partner to use.
1995-1999: The final years of the century saw approval of the first protease inhibitor, a new class of drugs for treating HIV, the first home-use AIDS test kit, the first antigen test kit to screen blood donors for HIV-1, and the first viral load test.
2000-present: In the first years of the 21st century, new formulations and combinations of medications were approved to reduce pill burden. Other approvals: HIV genotyping to help improve treatment outcome, the first nucleic acid test for plasma screening, the first rapid HIV test for use in outreach settings, and the first fusion inhibitor for treating HIV/AIDS.
In addition, AIDSinfo Launches a New Web Site Design on World AIDS Day 2004
AIDSinfo is commemorating World AIDS Day 2004, and the web site's second anniversary, with a new web site design. The new design, which is live today, features a more intuitive layout and consistent navigation. The colorful design, along with improved search functions, makes the site more accessible and useful for health care providers, researchers, patients, families, and users. The site is also rich in resources because of the significantly increased number of materials available for viewing online, downloading onto Pocket PC/Palm PDAs, and printing from PDFs.
AIDSinfo provides a wealth of information and resources, including the most up-to-date versions of the HIV/AIDS treatment guidelines and HIV/AIDS-related clinical trial information at www.AIDSinfo.nih.gov
Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
041201
FD041201
SOURCE: Food and Drug Administration (FDA).
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