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- W4301003207 abstract "With the hundreds of possible antiretroviral drugs and combinations available, it is imperative that a process of rapid screening in vivo be developed so that life-extending and life-saving combinations can be made available to those who need them. Bill Bahlman, an activist with the Treatment and Data Committee of ACT UP/New York, who is trying to get members of the Inter-Company Collaboration for AIDS Drug Development (ICC) to sponsor trials, has developed a proposal to test only one open label combination at a time. New open label combination screening studies would be started at a minimum of one per month. Each trial would involve thirty patients for a length of six weeks, and no longer than ten weeks. Each study would test three, four, or more drugs in combination. Any number of approved and/or unapproved drugs can be used in combination together. Endpoints would include CD4 and CD8 numbers and percentages, and drug safety and toxicity. Drug combinations providing a great viral suppression and a great improvement in lymphocyte count and percentage would rapidly be put into a controlled phase III study with other such combinations. Volunteers should be given continued access to the study regimen, open label, regardless of the study results. The controversy of the design is that it proposes an uncontrolled trial, since there is no randomly assigned control group to compare the test regimen against." @default.
- W4301003207 created "2022-10-04" @default.
- W4301003207 date "1995-04-21" @default.
- W4301003207 modified "2023-09-29" @default.
- W4301003207 title "Proposal: small trials for screening antiviral combinations." @default.
- W4301003207 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/11362403" @default.
- W4301003207 hasPublicationYear "1995" @default.
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