Survey: Community Recommendations for Clinical Research Involving Antiretroviral Treatment Interruptions in Adults
Survey response deadline: Monday, June 25, 2018

Research aiming to develop a cure for HIV infection (or induce long-term remission) can involve clinical trials and observational studies in which people living with HIV are asked to temporarily interrupt antiretroviral therapy (ART). The term used is analytical treatment interruption (ATI).

There are uncertainties regarding the safety of ATIs, and ongoing debates about how to design this research so that any risks to participants are minimized. For some ATIs, there are also concerns about the potential for an increased risk of HIV transmission to sexual partners of trial participants.

The primary purpose of this survey is to solicit the opinions of HIV treatment and research advocates on how to approach the use of ATIs in HIV cure-related research. The goal is to issue a report that will:

1) Provide a brief history and overview of treatment interruptions in HIV research
2) Outline the approaches to ATIs being taken in current cure-related trials
3) Present the results of this survey along with an update to a prior set of community recommendations released in 2014 that were initiated by Simon Collins at HIV i-Base and co-authored by Treatment Action Group and Project Inform: http://www.treatmentactiongroup.org/hiv/Treament-interruption-recommendations-2014 (this document provides additional background on ATIs that may be helpful for completing this survey).

The two types of ATI study design most commonly under consideration are:

Time to viral load rebound above the limit of detection, or other specified viral load threshold ("time to rebound ATI").

An extended ATI allowing the assessment of whether viral load "set point" is reduced after an initial rebound. These study designs may involved a specific time period such as 12 or 16 weeks, or be open ended depending on whether participants meet pre-specified criteria for restarting ART ("set point ATI").

In this survey we have attempted to ask questions relating to key aspects of ATIs. However, it is a complicated topic and we acknowledge that not all possible areas are covered. If you disagree with the premise of a question or feel that it has missed something important, please provide that feedback in your response (if it's not possible to do so in the answer to the question, there is also space at the end of the survey for general comments).

We are targeting HIV treatment and research advocates in order to draw on their experience of providing input into HIV research, but we're also happy to accept responses from other individuals and stakeholders. We will do our best to represent the breadth of feedback received in the final report.

An option is provided at the end to provide contact information for any respondents willing to review and provide feedback on the report when it is in draft form.

Note: issues relating to interrupting ART in pediatric HIV infection are not covered in this survey.

Please contact Richard Jefferys at Treatment Action Group with any questions: richard.jefferys@treatmentactiongroup.org



Sign in to Google to save your progress. Learn more
Next
Clear form
Never submit passwords through Google Forms.
This form was created inside of Treatment Action Group. Report Abuse