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To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. ... Investigational or non-FDA approved medication. ... Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.
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clinicaltrials.gov/ct2/show/NCT00002109
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Lactic acidosis is a potentially life-threatening disease associated with the treatment of chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may ... Individuals living with HIV who are on an antiretroviral regimen including one of D4T/ddI/ddC/AZT and have liver disease. ... U.S. FDA Resources...
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clinicaltrials.gov/ct2/show/NCT00202228
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Treatment Action Group ... Thus, where the access crisis for AIDS drugs in the late 1980s focused on experimental treatments, now, in the mid-1990s, there is a new access crisis focused on already FDA-approved treatments. If insurers won't cover them, PWAs won't get them, and they'll do no good.
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www.thebody.com/tag/june96a.html
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New drugs called protease inhibitors, first approved in 1995, were about to revolutionize the treatment of patients infected with the AIDS virus. ... Others in this class include ddi (didanosine), ddc (zalcitabine), D4T (stavudine), 3TC (lamivudine), and most recently Ziagen (abacavir). In 1997, FDA approved Combivir,
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www.fda.gov/fdac/features/1999/499_aids.html
www.fda.gov/fdac/features/1999/499_aids.html
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Study design: Treatment, Double-Blind, Safety Study ... - Investigational or non-FDA approved medication. ... - Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.
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www.druglib.com/trial/09/NCT00002109.html
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National Institutes of Health, National Institute for Allergy and Infectious Disease - March, 1996; ... In March, the Food and Drug Administration (FDA) approved the second and third of a new class of drugs called protease inhibitors. ... Other antiHIV drugs known as nucleoside analogues (AZT, ddI, ddC, d4T, 3TC) target a different...
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www.aegis.com/factshts/niaid/1996/niaid96_fact_sheet_pr...
www.aegis.com/factshts/niaid/1996/niaid96_fact_sheet_protease.html
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(i) PURPOSE OF THE STUDY: In December 1995 FDA approved Saquinavir for combination with other 2 antivirals drugs for the treatment of HIV/AIDS. ... HIV previous treatments begin 8 years before to begin the trial and failure to AZT, DDC, DDI, 3TC, D4T, ... (iv) CONCLUSIONS: SAQUINAVIR is a good option in very advanced HIV disease.
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www.aegis.com/conferences/hiv-glasgow/1996/P33.html
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These regulations allow the FDA to approve a drug for serious or life-threatening illnesses, ... To understand the current status of d4T, certain background should be kept in mind: * The studies are not comparing d4T against AZT (or against ddI or ddC, the other approved anti-HIV drugs) as a starting treatment.
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www.aids.org/atn/a-200-01.html
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And FDA has responded over the last decade by instituting new policies for drugs for serious and life-threatening diseases. In the last several years, the agency has approved four antiviral AIDS drugs, each in less than seven months: AZT, ddI, ddC and d4t. ... Another important mechanism is the Treatment IND. This has served...
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www.fda.gov/NewsEvents/Speeches/ucm101567.htm
www.fda.gov/NewsEvents/Speeches/ucm101567.htm
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