Protease inhibitors: Merck plans larger trials, expanded access. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023. NLM AIDSLINE Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.

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Protease inhibitors: Merck plans larger trials, expanded access. Clearinghouse, P.O. Box 6003, Rockville, MD 20849-6003. 800-458-5231 ext. 5023.

AIDS Treat News. 1995 Mar 24;(no 219):6. Unique Identifier : AIDSLINE AIDS/95700357
James JS

Abstract: Merck and Co. has announced that its comparative trial and open-label protocol for persons with HIV infection that have a CD4 count under 50--expected to start in mid 1995--could be expanded from 150 to over 1400 volunteers by the end of 1995. In addition, Merck is planning several large Phase III studies in other groups of patients: 1) 780 AZT-naive patients, with CD4 counts from 50 to 500, will be randomized to MK-639 (formerly called 735,524), AZT, or the combination; 2) 540 AZT-experienced patients with CD4 counts from 50 to 500 will be randomized to MK-639, d4T, or the combination; 3) in Brazil, 750 AZT-naive patients, with CD4 counts from 50 to 250, will be randomized to MK-639, AZT, or the combination; 4) 90 AZT-experienced patients, with CD4 counts between 50 and 400, will be randomized to MK-639, AZT plus 3TC, or the triple combination; 5) for patients with CD4 counts under 50, 300 patients will be randomized to MK-639, AZT plus 3TC, or the triple combination. Another large trial is planned for AZT-experienced patients, starting in late 1995, based on results of earlier trials. Merck plans to file for accelerated approval for MK-639. For information on enrolling in trials of MK-639, call (800) 379-1332.
Keywords: Acquired Immunodeficiency Syndrome/*DRUG THERAPY Clinical Trials, Phase III CD4 Lymphocyte Count Drug Approval Drug Industry Drug Therapy, Combination *Health Services Accessibility Human HIV Protease Inhibitors/*THERAPEUTIC USE Randomized Controlled Trials NEWSLETTER ARTICLE

KWDacquiredimmunodeficiencysyndrome/KWDdrugtherapyclinicaltrials,phaseiiicd4lymphocytecountdrugapprovaldrugindustrydrugtherapy,combinationKWDhealthservicesaccessibilityhumanhivproteaseinhibitors/KWDtherapeuticuserandomizedcontrolledtrialsnewsletterarticle
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