I am an 81-year-old white, gay male who first tested HIV-positive in January 1993. My initial instinct was to get involved in the scientific work to defeat this virus by volunteering for trials at the NIH [National Institutes of Health]. Over the course of 15 years I was a participant in 10 studies, mainly phase 1 drug trials. In one trial, I was one of the first two humans to receive the drug after testing in non-human primates! My rationale then was, as it is now—if not me, then who?”
Six of the 10 studies in which I participated included an analytical treatment interruption (ATI). In one study I thought my results suggested that I might be a “partial controller.” So, I volunteered for what promised to be a scientifically exciting and significant study of how the body’s own immune system can control HIV. The study involved closely monitored periods without taking ART, the longest of which for me was 914 days. More recently, I have worked with NIH staff to ensure that my body will be donated expeditiously on death to enable this rewarding history of scientific contribution to be rounded out.
I was aware that there was some risk involved in suspending ART, so I discussed the risks with the study clinicians as well as with my own physician. I always felt that they gave me honest, scientifically-based assessments of the risks and I never felt any pressure to participate or resistance to terminating participation. I was grateful and impressed by the amount of time that senior study clinicians devoted to giving detailed answers to questions I had about the design, rationale and progress of the studies.
I took a close interest in the clinical data being gathered during the ATIs, in particular absolute and trend values for HIV viral loads and CD4/CD8. I remained healthy throughout all the studies with no side effects or adverse events attributable to the studies.
My experience with ATI was uniformly positive and uneventful with no wishes for different outcomes.
I am fortunate to have had a scientific education studying physiology—but that was in 1960–1963, an earlier era! This enabled me to look into developments and issues in HIV research as I got involved. Informed consent processes present a challenge: they must above all be written in language that is clearly understandable by any prospective participant, no matter what their educational background. But they also need to be scientifically precise. I think lay members of CABs (community advisory boards) can contribute usefully in honing informed consent forms to ensure that they are intelligibly accurate.
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