Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention

摘要: This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical methods for HIV. The stakes this area research are high, given the continued high rates infection many countries and budget limitations that have constrained efforts expand treatment all who currently HIV-infected. New still needed; at same time, some existing interventions been proven effective but not yet widely available where they most urgently needed. tensions field well known subject extensive debate. There is no single trial design can optimize ethically important goals commitments involved research. Several recent articles described current difficulties designing HIV trials, especially resource limited settings; however, there consensus how handle decisions, international guidelines offer conflicting advice. acknowledges these deep dilemmas moves beyond a simple descriptive approach an organized method considering what designs will be acceptable balancing relevant criteria providing justification specific decisions.