Work

53 Perceptions of HIV remission (“cure”) trials and trial intentions among potential participants treated in acute HIV infection

Year: 2016

Type: article

Abstract: Background: According to ClinicalTrials.gov,work toward a cure and long-term sustainable remission of HIV is currently the focus of 19 completed studies and at least 35 ongoing or planned ones.A central ethical challenge surrounds the benefit/risk ratio in some of these studies.Many would impose substantial risks, uncertainties, and burdens on study participants.Interventions under consideration include bone marrow transplantation, antineoplastic or immunomodulatory drugs, ART interruptions, invasive tissue sampling, and other interventions that carry either high risk, or wholly unknown risk, often firstly performed on HIV-infected patients.As ART has become more effective, safer and more convenient, the overall prospect of medical harm from participation in such early-phase studies could exceed any prospect of direct medical benefit.Is it ethical to ask patients to participate in such studies?Description: A wide spectrum of ethical solutions are conceivable to the benefit/risk ratio challenge.Some were drawn from review of solutions to similar challenges in other areas of clinical research (e.g.Phase I cancer studies; various First-in-Human studies).Others use recent insights in several areas of practical ethics to suggest new candidate ethical solutions.The talk maps and comments on these many candidate solutions.Lessons learned: The candidate solutions reviewed fall into four categories: ones that seek to reduce risks in early-phase cure and remission studies; ones that enhance the medical or nonmedical benefits for these studies' participants (or show that those were adequate in the first place), ones that focus on participants' free and informed consent to participate, and ones that emphasize the large benefits to nonparticipating patients.Conclusions/Next steps: The benefit/risk ratio challenge in some early-phase HIV cure and long-term remission studies is serious enough that HIV investigators and oversight bodies should consider a wide range of candidate solutions.Ethicists should help determine which solutions makes ethical sense.Empirical investigators should check their acceptability to a variety of stakeholders.

Source: Journal of Virus Eradication

DOI: 10.1016/s2055-6640(20)30998-5