The foggy ethics of HIV cure studies

Is it acceptable to conduct a study in which a person living with HIV pauses their antiretroviral therapy to try an experimental cure?

“Interrupting a proven HIV treatment for a potentially extended period can cause harms,” Karine Dubé, Dr.P.H., and Amaya Perez-Brumer, Ph.D., wrote in The Lancet HIV. “The ethical question is whether the potential harms are proportional and justified.”

Dubé is a social scientist at the University of California San Diego who is asking tricky questions about research searching for an HIV cure, in particular studies that ask trial participants to interrupt their antiretroviral therapy. While an extended analytical treatment interruption (ATI) allows researchers to monitor the impact of an experimental intervention on viremia and immune response, this has risks for adult study volunteers.

Participants may experience acute retroviral syndrome, a fall in their CD4 cell count, and the long-term consequences of immune activation and inflammation – as evidenced in a rare study that followed participants for nearly two decades after a treatment interruption and found an elevated rate of serious illnesses such as cancer, liver disease, and kidney disease.

In addition, participants on an ATI cannot rely on what has become a central tenet of viral suppression: “undetectable equals untransmittable” (U=U), the scientific fact of HIV non-transmissibility through sex while a person is on fully effective antiretroviral therapy. As such, cure participation could have a negative impact on sexual partners: There are two recorded cases of HIV transmission during ATIs, one in France and one in Spain.

The impact may also be psychological, not just physiological. “We need to remember that viral rebounds will mean much more for participants,” Dubé said during a presentation at the 2024 HIV Glasgow conference. This is expressed clearly in the qualitative research she has done with cure study participants.

Said one study participant in Philadelphia: “I’ve been undetected for such a long time and just to see those numbers go up like that, I was kind of worried like, OK, are they going to keep going up and not going to come back down?”

Other participants expressed disappointment that the intervention had not worked and that a cure has not been found. “I’m not saying I feel like a failure, but I just feel like I’d let the whole HIV community down,” one said.

Read the full story by Roger Pebody at TheBodyPro.