ATI: ‘A trial interruptus’

Thomas J. Villa works to help end the HIV epidemic as a writer, Community Advisor to and serial participant in HIV clinical research. Tom is an Ambassador for the HOPE Martin Delaney Collaboratory for HIV Cure Research, a Community Advisor to the RID Martin Delaney Collaboratory, and a contributor to the AIDS Clinical Trials Group (ACTG) Partner Protection Working Group. 

I took part in an ATI trial to test if a first in-human combination of two monoclonal antibodies was safe and effective to control HIV without taking daily ART. The trial was to last 12–18 months, with each participant undergoing two ATIs.

I started the first ATI at my baseline clinic visit and continued for about five weeks until my viral load became detectable at a low level (200+ copies/mL). At the next clinic visit, I was given an infusion that took about an hour. I had no reaction whatsoever and returned home in time for lunch. I restarted taking ART the following day, and my HIV viral load was back to undetectable levels after four weeks. I carried on with daily HIV meds and normal life for three months before starting the next phase of the trial.

The second ATI, expected to last 16–24 weeks, was to see how long my immune system, now fortified by the investigational product, could keep HIV under control without daily ART. I was comfortable with the frequency of safety labs (every two weeks), clinic visits (monthly) and ready availability of my research team by telephone during the ATI.

This ATI was interrupted after eight weeks when much of the nation’s research staff was redirected to address the COVID-19 pandemic. While disappointed, I understood this decision and restarted ART immediately. I was surprised by how much this early termination of the trial affected me over the next several weeks—at how emotionally invested I had become in safely completing my participation—so I would like to emphasize the need for mental health support services both during and after ATI participation. In addition, we should use our experiences with early ATI trials to create formal mechanisms to react to future external shocks like COVID-19. Let’s prepare now.

I also suggest enhancements to the informed consent process to provide more complete information that keeps pace with rapidly advancing cure science. While I committed to abstaining from sex during the ATI to remove any risk of HIV transmission, this approach may not be practical or acceptable to other participants. Special attention to partner protection strategies is urgently needed before ATI trials are scaled up to large numbers of participants in diverse settings and/or as the duration of ATI lengthens to many months or years.

We also must assess the impact of ATI participation on other people in participants’ immediate social circles—spouses, sex partners, family members, neighbors and co-workers among them. Their needs must be understood and addressed for ATI trials to continue successfully.

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