Preparations for HIV vaccine trials: moving from baseline studies to efficacy trials. 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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Preparations for HIV vaccine trials: moving from baseline studies to efficacy trials.

AIDS Res Hum Retroviruses. 1994;10 Suppl 2:S191-3. Unique Identifier : AIDSLINE MED/95169479
Hoff R; DAIDS, NIAID, NIH, Bethesda, Maryland 20892-7620.

Abstract: In summary, much has been accomplished in the past year, but much still remains to be done before we can embark on an efficacy trial. With the availability of a fully operational network, the NIAID has in place the resources and mechanisms to complete baseline feasibility studies and to conduct the future trials. As presented at the 1993 conference and reported in this supplement, the preliminary data from the current baseline studies indicate that such trials are feasible, although not without considerable problems. To reach our efficacy trials preparedness goal, we will need to work especially hard in the coming months to identify and resolve the remaining technical, ethical, legal, and political constraints to initiating trials. We must also listen to community concerns and educate the public about the trials if we expect to gain community support and volunteers for the study. Finally, we must evaluate the supporting data pertaining to candidate products for efficacy trials. These will not be easy tasks or decisions, but we must approach them with vigor.
Keywords: AIDS Vaccines/*PHARMACOLOGY Clinical Trials/*METHODS Female Human HIV Infections/PREVENTION & CONTROL International Cooperation Male National Institutes of Health (U.S.)/ORGANIZATION & ADMIN Research Design United States World Health Organization JOURNAL ARTICLEKWDaidsvaccines/KWDpharmacologyclinicaltrials/KWDmethodsfemalehumanhivinfections/prevention&controlinternationalcooperationmalenationalinstitutesofhealth(uKWDsKWD)/organization&adminresearchdesignunitedstatesworldhealthorganizationjournalarticle
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M9561137

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