Inside an HIV Cure Trial

Research question

Two years ago, amfAR reported preliminary results from a University of California, San Francisco-amfAR cure trial. It was complex, combining five interventions over 34 weeks: an HIV DNA vaccine, the immune hormone IL-12, a vaccinia boost vaccine, broadly HIV neutralizing antibodies, and a drug to activate the immune protein TLR9.

The study established proof of concept that combination immunotherapy may induce post-treatment control by altering facets of the virus or the immune response to it.

As efficacy of any such trial can only be proven in people living with HIV (PLWH) themselves, an analytic treatment interruption, or ATI, was also required. In an ATI the participant agrees to stop taking antiretroviral therapy (ART) at the trial’s conclusion to determine if or when HIV reappears. The researchers emphasized then that little was known about the personal experiences of PLWH enrolled in such trials, including psychological stressors and the need to change sexual behaviors to protect themselves and their sexual partners.

Findings

In this new investigation, results of surveys to capture participants’ perspectives and experiences were analyzed.

The study involved nine cisgender men and one transgender woman of median age 36.5. An enrollee’s understanding of requirements of the trial; motivations; expectations; perceived risks, benefits, and burdens of participation; and perspectives on restarting ART and protecting intimate partners was sought. All understood the scientific goals.

Eight of the 10 said they joined the trial to “help advance research.” Expectations were realistic, with only two feeling they had at least a good chance of achieving HIV cure. Although most experienced feelings of worry related to viral rebound, and relief when restarting ART, all four who completed the final survey also expressed willingness to participate in future HIV cure trials.  

Impact

The authors concluded that both qualitative and quantitative approaches should be implemented in HIV cure trials “to optimize human-centered research implementation.” A risk mitigation plan to protect partners from HIV during the ATI, including referral to pre-exposure prophylaxis (PrEP) clinics, was suggested. Two of the 10 participants reported forgetting to take their ART after the ATI, emphasizing the need for counseling around ART adherence.

amfAR’s role

amfAR was a funder of this research. amfAR grantee John A. Sauceda, PhD, of the Center for AIDS Prevention Studies (CAPS), University of California, San Francisco, was a co-author of this paper.

Original article
http://www.ncbi.nlm.nih.gov/pubmed/39907119

Dr. Laurence is amfAR’s senior scientific consultant.

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