The were ten updates to the TAG listing in July 2025.
New Additions
Four newly registered HIV cure-related studies were added:
Oxford University in the UK is sponsoring AbVax, a phase II combination trial that will administer therapeutic vaccines designed to induce T cell responses against HIV plus two broadly neutralizing antibodies (bNAbs), teropavimab and zinlirvimab (also known as 3BNC117-LS and 10-1074-LS). A novel aspect of the protocol involves the use of a short interruption of antiretroviral therapy (ART) that the researchers are calling treatment interruption induced viremia (TIIV), intended to interact with the combination therapies to potentially bolster immune responses prior to the conduct of a longer analytical treatment interruption (ATI).
ViiV Healthcare plans to assess whether adding the CD4 attachment inhibitor fostemsavir to the long-acting bNAb N6-LS can reduce the HIV reservoir. Approximately 100 participants will be enrolled, either already receiving a standard of care ART regimen with an integrase inhibitor or naïve to ART and initiating such a regimen on entry. Participants will be randomly assigned to receive either N6-LS, N6-LS and fostemsavir, or just ART (the control group). Primary endpoints include the size and activity of the HIV reservoir measured by cell-associated HIV RNA and levels of intact and defective HIV DNA.
A new trial of the Janus kinase (JAK) inhibitor baricitinib is being launched in Barcelona, Spain. Laboratory studies indicate baricitinib may have the potential to reduce HIV latency and reactivation. The main objective of the study is to evaluate safety, tolerability and effects on CD4 T cells, with secondary outcomes including measures of the HIV reservoir.
Merck has initiated a new trial of a candidate targeted activator of cell kill (TACK) molecule, MK-4646, in Moldova. TACK molecules are non-nucleoside reverse transcriptase inhibitors (NNRTIs) that have been optimized to mediate destruction of cells containing HIV via a mechanism that involves recognition of the viral protease enzyme by innate cellular immune sensors (see previous blog post from 2023). The phase I study is open for enrollment with an anticipated completion date of April 2026. The protocol is focused on safety, tolerability and antiretroviral activity in people with HIV who haven’t yet received ART. A small safety study in HIV-negative people was already completed in Belgium last year, but to our knowledge results haven’t yet been publicly presented.
Updates to Enrollment Status
A study of the immunomodulatory anti-cancer drug pomalidomide in people on ART that was added to the listing in November 2024 is now open for enrollment in Denmark. Recruitment remains pending at an additional site in Australia. The protocol includes an ATI to evaluate whether receipt of pomalidomide alters HIV viral load rebound.
New Links to Study Results
Links were included to five abstracts presented at the recent International AIDS Society Conference on HIV Science in Kigali, Rwanda.
Marina Caskey debuted preliminary results from a small combination study involving two bNAbs (3BNC117-LS and 10-1074-LS) plus the IL-15 cytokine superagonist N-803. Caskey noted that four participants suppressed HIV viral load to low levels after an ATI, with two experiencing posttreatment control for 72 weeks of follow up. Detailed coverage is available from Liz Highleyman in an article for Aidsmap, who thankfully have been able to maintain their conference coverage and website resources after support from the Terrence Higgins Trust averted a feared complete closure.
Two IAS 2025 abstracts addressed findings from an HIV cure-related study in the FRESH cohort of young women in South Africa. The primary results were presented at CROI earlier this year by Thumbi Ndung'u (see prior blog post). Principal investigator Krista Dong described lessons learned from conducting the first HIV cure interventional trial in Africa in one presentation, and late-breaking results from the social science component of the protocol in a second abstract. In the latter analysis, ATIs were found to be tolerable psychologically by participants, but there was evidence of increased anxiety and depression associated with extended time off ART. The abstract concludes: “Findings support the inclusion of young women in ATI-inclusive trials but highlight the need for mental health assessments and directed psychosocial support, especially for trials that include prolonged ATIs.”
Gaspar Canepa from the biotech company American Gene Technologies presented evidence that their gene therapy strategy for protecting and enhancing HIV-specific CD4 T cells may have led to reductions in the size of the intact HIV reservoir in some study participants. The abstract stresses “these results should be interpreted with caution” given the small numbers .
Euphorbia kansui is a traditional Chinese medicine that has been reported to potentially have HIV latency-reversing activity. Several years ago, Jingna Xun and colleagues conducted a clinical trial in nine men on ART and at IAS 2025 they reported some evidence of cell-associated HIV RNA reductions in four participants and latency reversal (viral load transiently increasing to >50 copies/ml) in two participants, without any serious adverse events. The researchers conclude that the results may be sufficient to “warrant further investigation” of the intervention.
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