Removing One Barrier to Protecting Sex Partners in HIV Remission Studies With a Treatment Interruption.

Nir Eyal

doi:10.1093/infdis/jiz162

Abstract

Only a few of the recommendations made in this supplement are implemented in ongoing HIV remission studies that involve an analytical treatment interruption. The absence of these recommendations in protocols puts sexual partners of study participants at serious risk. This paper addresses one possible barrier to implementation: a certain misunderstanding among sponsors and research entities.

Highlights

A few of the recommendations made in this supplement are implemented in ongoing human immunodeficiency virus (HIV) remission studies that involve an analytical treatment interruption
It is noteworthy that only some of the recommended measures are part of either current or completed protocols [1]. This contrasts with how researchers and sponsors tend to address participant infection in, for example, HIV prevention trials—where participants usually receive HIV counseling and a “standard of prevention” package of this or that form [2] throughout the trial
Sponsors, or ethics reviewers have different views than ours on what protections would be appropriate. Perhaps they have not yet thought through these matters

Summary

Introduction

A few of the recommendations made in this supplement are implemented in ongoing HIV remission studies that involve an analytical treatment interruption. HIV; research ethics; analytic treatment interruption; HIV cure-related studies; clinical trials; human subject research. This supplement recommends some measures to help protect participants’ sexual partners from human immunodeficiency virus (HIV) infection in HIV remission studies with an analytical treatment interruption (ATI), and to keep any remaining risks ethically defensible.

Results

Conclusion