For September 2025, there were 11 updates to the TAG listing.
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New Additions
One new clinical trial was registered over the past month, an investigation of the cytokine interleukin-15 (IL-15) led by Michael Peluso at the University of California San Francisco (UCSF). The protocol will administer N-803, a modified version of IL-15 approved for the treatment of bladder cancer, and involves an analytical treatment interruption (ATI) to assess whether the intervention enhances control of HIV viral load when antiretroviral therapy (ART) is interrupted. Enrollment is by invitation, likely from the large SCOPE Cohort of people on long term ART at UCSF. The study is supported by amfAR.
Updates to Enrollment Status
An HIV vaccine study in people with HIV is listed as temporarily closed “to study agents/products” (no details are provided). The protocol is evaluating protein-based candidates designed to spur early steps toward induction of broadly neutralizing antibodies (bNAbs), and investigating the effects of an ATI on vaccine-induced immune responses.
An ACTG trial investigating dual bNAb therapy at sites in Botswana, Malawi, and South Africa is now closed to enrollment. The protocol included an ATI and recruitment was stopped early after a review indicated that rates of post-treatment control were too low to support continuation.
Four trials have been completed and moved to table 3 in the listing:
- A study of BCG vaccination in people on ART in Zurich. The registry record hasn’t been updated for some time, but an entry on the website of the Swiss Ethics Committees states “study has ended.”
- An ACTG protocol investigating the effects of early ART initiation that recruited 195 participants and published results last year.
- The IMPAACT network’s observational study assessing outcomes in children who received early ART.
- A study of fecal microbiota translantation (FMT) led by Jean-Pierre Routy in Canada; to our knowledge results are pending.
New Links to Study Results
Four entries in the listing had links added to newly published papers:
- Elizabeth Nguyen and colleagues reported results from the social science component of an ongoing ATI study in the SCOPE Cohort at USCF in the journal AIDS Research and Human Retroviruses. Participants demonstrated a high degree of understanding of the protocol and low rate of regrets about joining. The authors note their findings add to evidence that partner protection support is needed to reduce potential transmission risk during ATIs .
- Results from ViiV Healthcare’s completed BANNER trial of the long-acting bNAb N6-LS (VH3810109) were published in early September in the Journal of Infectious Diseases. Data has previously been shared at conferences, demonstrating antiretroviral activity and safety.
- An analysis from a completed Canadian trial of oral cannabinoid capsules focusing on the effects on the endocannabinoidome and gut microbiome was published in the journal Cannabis and Cannabinoid Research. Two components of the endocannabinoidome, 2-eicosapentaenoylglycerol (2-EPG) and 2-oleoylglycerol (2-OG), were reportedly reduced, but no significant changes in the gut microbiome were documented.
- Lastly, results from a small drug interaction study assessing the effects of co-administering cobicistat or voriconazole on the TLR7 agonist vesatolimod were published in Infectious Diseases and Therapy. Neither drug affected the tolerability of vesatolimod, but cobicistat did significantly increase plasma concentrations.
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