The past month has seen relatively few updates for TAG’s HIV cure-related clinical research listing. One new observational study was entered into the clinicaltrials.gov registry, two trials have been completed or ended, an ongoing investigation of the anti-CMV drug letermovir has reopened for enrollment after a pre-planned pause, and a social science assessment of factors associated with declining to enroll in a cure-related trial is presenting results at the AIDS Impact conference next month.
The new observational study is sponsored by Bayside Health in Australia and aims to assess the size of the HIV reservoir and HIV-specific immune responses in three cohorts:
- People who initiated antiretroviral therapy (ART) with high CD4 T cell counts (>800 cells/μL).
- People who achieved a CD4 count increase to >1000 cells/µL within 48 months of starting ART.
- Age-matched HIV positive controls from the Alfred HIV clinic who have CD4 T cells counts between 500 and 800 cells/µL, or who do not reconstitute their CD4+ T cells to >1000 cells/µL within 48 months.
The study is recruiting at The Alfred in Melbourne Australia, the primary contact is researcher and writer Jillian Lau, MBBS, who also shares HIV cure research information and news via an excellent twitter account.
Two trials have ended and shifted to the completed table:
- An investigation of canakinumab (an antibody that inhibits the cytokine IL-1β) has been completed by Priscilla Hsue, MD, at the University of California, San Francisco. The primary purpose was to assess effects on markers of inflammation and cardiovascular disease risk, but the protocol also cites evaluation of HIV reservoir size as an additional outcome measure. Results from an initial safety cohort of ten participants were published in the Journal of the American College of Cardiology in 2018. Results from an additional 33 participants are reported in the clinicaltrials.gov registry entry, but the format is difficult to interpret and hopefully additional publications or presentations will be forthcoming.
- A small study of kansui, a substance used in traditional Chinese medicine that may have HIV latency-reversing activity, has been ended at the University of Utah. The rationale for the research derived from evidence that a particular component of kansui, ingenols, can reverse HIV latency in laboratory studies. The study enrolled five participants but the original plan to add several more was stymied by the COVID-19 pandemic and the ending of funding support. Lack of funding is also slowing plans to analyze collected samples, but the researchers hope to eventually present any findings.
Back in January we noted that the AIDS Clinical Trials Group (ACTG) had temporarily paused recruitment for a trial of the anti-CMV drug letermovir in people with HIV. The pause was planned in the protocol to allow for a preliminary evaluation of the effects of the drug on inflammatory markers among the first 40 participants before deciding whether to continue enrollment. The trial registry record was updated on April 26 to indicate that it's recruiting again, with a target of 180 participants in total. The study is taking place in the United States with sites in Alabama, California, Colorado, Illinois, Massachusetts, Missouri, New York, Ohio, Pennsylvania, Tennessee, Texas, and Washington State. The main outcome measures are markers of inflammation, but analyses of effects on HIV persistence are also planned.
EHVA T02 was a muti-site HIV cure-related trial in Europe that intended to investigate the effects of therapeutic vaccination and the antibody vedolizumab (trade name Entyvio). Unfortunately, the study was unable to proceed due to slow enrollment and the expiry dates of the experimental interventions that were due to be administered. However, a related social science investigation into the perspectives of potential enrollees conducted by Sarah Lefebvre and colleagues was able to collect information from a small number of people who declined to participate. The results are being presented at the upcoming AIDS Impact conference in Stockholm next month (see abstract). The registry record for the social science study was updated late yesterday to note that it has now been terminated, so it will shift to the completed studies table when the next monthly update to TAG’s listing is posted in June.
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