Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach

Michael J Peluso; Lynda Dee; Shirley Shao; Jeff Taylor; Danielle Campbell; Simon Collins; Monica Gandhi; Rowena Johnston; Steven G Deeks; John A Sauceda; Karine Dubé

doi:10.1093/cid/ciaa1260

Operationalizing Human Immunodeficiency Virus Cure-related Trials with Analytic Treatment Interruptions During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Pandemic: A Collaborative Approach

Clin Infect Dis. 2021 May 18;72(10):1843-1849. doi: 10.1093/cid/ciaa1260.

Authors

Michael J Peluso¹, Lynda Dee^{2

3

4

5}, Shirley Shao¹, Jeff Taylor^{3

5

6

7}, Danielle Campbell^{4

5

8}, Simon Collins⁹, Monica Gandhi¹, Rowena Johnston¹⁰, Steven G Deeks^{1

10}, John A Sauceda¹¹, Karine Dubé^{11

12}

Affiliations

¹ Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, California, USA.
² AIDS Action Baltimore, Baltimore, Maryland, USA.
³ amfAR Institute for HIV Cure Research Community Advisory Board, USA.
⁴ Delaney AIDS Research Enterprise Community Advisory Board, USA.
⁵ Martin Delaney Collaboratory Community Advisory Board, USA.
⁶ HIV + Aging Research Project, Palm Springs, California, USA.
⁷ University of California, San Diego, AntiViral Research Center Community Advisory Board, San Diego, California, USA.
⁸ Charles R. Drew University of Medicine and Science, Los Angeles, California, USA.
⁹ HIV i-Base, London, United Kingdom.
¹⁰ amfAR Institute for HIV Cure Research, San Francisco, California, USA.
¹¹ Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.
¹² University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.

Abstract

Efforts to recognize and minimize the risk to study participants will be necessary to safely and ethically resume scientific research in the context of the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. These efforts are uniquely challenging in the context of human immunodeficiency virus (HIV) cure clinical trials, which often involve complex experimental therapy regimens and perhaps analytic treatment interruption, in which participants pause antiretroviral therapy. In this viewpoint, we discuss our approach to reopening an HIV cure trial in this context, with a focus on key considerations regarding study design, informed consent and participant education, and study implementation. These recommendations might be informative to other groups seeking to resume HIV cure research in settings similar to ours.

Keywords: COVID-19; HIV cure–related trials; SARS-CoV-2; analytical treatment interruptions; risk mitigation.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

COVID-19*
HIV
HIV Infections* / drug therapy
HIV Infections* / epidemiology
Humans
Pandemics
SARS-CoV-2

Abstract

Publication types

MeSH terms

Grants and funding