title: [AIDS, activism, and the regulation of clinical trials in Brazil: Protocol 028].
abstract: This paper examines the politics and practices of drug evaluation in Brazil. It traces the history of AIDS activists' influence on the organization of modern clinical trials and their scientific rationale. Using the Merck indinavir trial as a case study, the authors discuss how organized civil society has developed strategies to intervene in the course of drug evaluation trials, shaping them according to its own interests. Adopting translation sociology as the theoretical framework, the paper describes and analyzes the strategies used by activists from "Grupo PelaVidda/SP" (an AIDS NGO) to build a consensus concerning indinavir monotherapy's lack of efficacy. The study considers the several regulatory forums involved in dealing with the controversy during the trial period.
authors.affiliation: Núcleo de Assistência Farmacêutica, Escola Nacional de Saúde Pública, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, 21041-210, Brasil. dora@ensp.fiocruz.br
authors.forename: M A
authors.initials: MA
authors.lastname: Oliveira
authors.forename: E M
authors.initials: EM
authors.lastname: Santos
authors.forename: J M
authors.initials: JM
authors.lastname: Mello
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D001938:Brazil; D002985:Clinical Protocols / Q000592:standards*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D003256:Community Participation; D016265:Conflict of Interest; D017277:Drug Approval; D004995:Ethics, Professional; D017320:HIV Protease Inhibitors / Q000627:therapeutic use; D006801:Humans; D019469:Indinavir / Q000627:therapeutic use; D007880:Legislation, Drug
chemical_list: D017320:HIV Protease Inhibitors; D019469:Indinavir
vernacular_title: AIDS, ativismo e regulação de ensaios clínicos no Brasil: o Protocolo 028.