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The history of AIDS (Acquired Immunodeficiency Syndrome), with timelines, photos, and links to resources on the Internet. Endeavoring to raise public awareness through understanding.
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The History of AIDS: Timeline of the History of HIV/AIDS: 2003 2003 In January 2003 FDA proposed a new labeling warning statements for all over-the-counter (OTC) vaginal contraceptive drug products containing nonoxynol 9. These warning statements will advise consumers that vaginal contraceptives containing nonoxynol 9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings will also advise consumers that frequent use of vaginal contraceptives containing nonoxynol 9 can increase vaginal irritation. Increased vaginal irritation from use of nonoxynol 9 may increase the possibility of transmission of the AIDS virus (HIV) and STDs from infected partners. On February 3, 2003 the Department of Health and Human Services (HHS) expanded availability of the rapid HIV test from the current 38,000 laboratories to more than 100,000 sites, including physician offices and HIV counseling centers. The expanded use to additional sites was granted by HHS under a Clinical Laboratory Improvement Amendments (CLIA) waiver. Widespread availability of the rapid HIV test is likely to increase overall HIV testing and decrease the number of people -- an estimated 225,000 Americans -- who are unaware they are infected with the HIV virus. Early testing enables infected individuals to obtain medical care earlier in the course of their infection, potentially saving lives and limiting the spread of this deadly virus. FDA approved the OraQuick test in November as a moderate complexity test. Moderate complexity tests must be performed in a CLIA-approved laboratory by CLIA-certified laboratory staff. Manufacturers can request a CLIA waiver that allows the test to be used under less stringent controls. CLIA-waived tests can be performed and interpreted in a physician's office or other settings without having to be sent out to a CLIA-certified laboratory. To qualify for a waiver, a test must be simple, accurate and present no reasonable risk of harm. OraSure Technologies tested the accuracy and ease of the test by having 102 untrained users administer the test at four sites in the United States, including a local AIDS foundation, a program for homeless and low income and community-based HIV organization. These users were able to obtain results similar to those obtained in the firm's original studies done in laboratories. On March 3, 2003, FDA held a meeting of its Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to seek public discussion and advice on issues related to the development of antiretroviral drugs in human immunodeficiency virus (HIV)-infected and HIV-exposed neonates younger than 4 weeks of age. Questions addressed included: (1) Is it feasible and ethical to conduct studies of antiretroviral drugs in HIV-infected or exposed neonates in the United States? (2) Should we continue to request pharmacokinetic and safety studies in HIV infected neonates for every drug under development or should we develop criteria for deciding which drugs should be studied. (3) If studies are conducted in resource poor countries, where perinatal transmission rates are still unacceptably high, can the results be extrapolated to pertain to the U.S. population? Briefing Information | Slides | Minutes | Complete Transcript On March 15, 2003 FDA approved FUZEON (enfuvirtide, also known as T-20), for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children ages 6 years and older. This marked the first approval, worldwide, of a new class of drugs known as "fusion inhibitors," which interfere with the entry of HIV-1 into cells by inhibiting the merging of the virus with the cellular membrane. This inhibition blocks HIV before it enters the human immune cell. Roche Pharmaceuticals of Nutley, N.J., has licensed the product from Trimeris Inc. of Durham, N.C., and will distribute FUZEON. Additional Information on FUZEON: Choose "F" from the Index, and scroll down to "Fuzeon" at the end of the list. On April 1, 2003 a special nutrition management and HIV infection supplement to Clinical Infectious Diseases, a journal of The Infectious Diseases Society of America, was published (Clinical Infectious Diseases, Volume 36, Supplement 2), stressing the importance of nutrition as part of the medical treatment of HIV. It contains a special report on current issues related to The supplement is a collaborative work of more than 50 authorities representing a wide range of expertise in conjunction with 5 federal agencies: the Health Resources and Services Administration, the Food and Drug Administration, the Centers for Disease Control and Prevention, the National Institutes of Health, and the Department of Veterans Affairs. On April 30, 2003, the Food and Drug Administration approved a new dosing formulation of Viracept (nelfinavir mesylate) a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. Viracept has been available in 50 mg oral powder and 250 mg tablets. The new formulation of 625 mg reduces the pill burden from five-250 mg tablets twice a day to two-625 mg tablets twice a day, potentially facilitating adherence to treatment regimens. On May 13, 2003, FDA held a meeting of its Antiviral Drugs Advisory Committee to discuss the new drug applications (NDA) 21-567 and 21-568, Reyataz™ (atazanavir sulfate) capsules and powder for oral use, Bristol-Myers Squibb Company, proposed for the treatment of HIV infection in combination with other antiretroviral agents. Briefing Information | Transcript | Slides On June 20, 2003, FDA approved Reyataz (atazanavir sulfate) [PDF], a protease inhibitor, manufactured by Bristol-Myers Squibb Company of Princeton, NJ, to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection. Approval of this drug permits patients access to a once-a-day protease inhibitor. Reyataz appears to have minimal impact on lipid parameters such as triglycerides and cholesterol. Product Label On July 2, 2003, FDA approved Emtriva (FTC, emtricitabine) [PDF], a new nucleoside reverse transcriptase inhibitor (NRTI) manufactured by Gilead Sciences, Foster City, CA, USA, for use in combination with other anti-retroviral agents for the treatment of patients with HIV infection. Product Label In July 2003 an important drug warning was issued regarding Early Virologic Non-Response in Patients with HIV Infection Treated With Lamivudine, Abacavir and Tenofovir. On August 8, 2003, an important drug warning was issued regarding Important New Pharmacokinetic Data for REYATAZ™ (atazanavir sulfate) in combination with Viread® (tenofovir disoproxil fumarate) On August 15, 2003, Viread labeling was updated to include results from Gilead Sciences study 903 (antiretroviral naïve subjects). The revised label also includes new dose recommendations for patients with renal impairment, a new warning about HIV/HBV coinfection, dose recommendation for ddI when used with tenofovir, and updated information regarding bone effects. In addition, the original label stated that Viread should be taken with a meal. New information indicates that Viread may be taken without regard to food. This information can be found in the Dosage and Administration section of the new label. On August 20, 2003, FDA held a meeting of its Antiviral Drugs Advisory Committee to discuss clinical trial design issues in the development of topical microbicides for the reduction of HIV transmission. Agenda | Briefing Information | Slides 2002 ...Last ||| Next... 2004 |