March tends to be the busiest month for updates to TAG’s HIV cure-related clinical research listing because of results being presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI). Today’s update includes links to 30 abstracts from CROI 2023; posters can be downloaded from the abstract pages, but webcasts of oral presentations won’t be publicly accessible until around March 24 (one month after CROI ended). More detailed coverage of the study results presented at CROI will be posted to the blog when all presentations become freely available, hopefully next week.
Three new HIV cure-related studies were added to registries over the past month, one interventional and two observational:
The US Military HIV Research Program continues a longstanding collaboration with the Thai Red Cross AIDS Research Centre in Bangkok, launching a multi-pronged combination trial in people who started antiretroviral therapy (ART) during acute HIV infection. The experimental therapies that will be administered are two long-acting broadly neutralizing antibodies (bNAbs) — VRC07-523LS and PGDM1400LS — a souped-up version of the cytokine IL-15 named N-803, and three different therapeutic HIV vaccine products: an adenovirus serotype 26 vector and a modified Vaccinia Ankara strain vector encoding HIV antigens (Ad26.Mos4.HIV and MVA-BN-HIV) plus a gp120 protein boost with ALFQ adjuvant (A244d11gp120/ALFQ). Participants need to have been on ART for at least 48 weeks with viral loads suppressed to less than 50 copies/ml, have HIV that’s sensitive to the bNAbs in laboratory tests, and lack genetic traits (HLA types) that have been associated with immune control of HIV replication. The study involves an analytical treatment interruption (ATI) and will measure the time to sustained viral rebound (defined as ≥1000 copies/ml for four consecutive weeks, without a decline by >0.2 logs from the previous measurement). Recruitment has not yet begun.
APRIL (Analysis of the Persistence, Reservoir and HIV Latency) is a pending new observational study being conducted at the University Hospital, Strasbourg, France which involves collection of blood samples from people on ART to analyze the HIV reservoir. In the Netherlands, researchers at the Universiteit van Amsterdam have opened NOVA, an observational investigation into the properties of the HIV reservoir and HIV-specific immune response that may be associated with the capacity for post-treatment control of viral load. The registry description of NOVA suggests that it may eventually involve an ATI, but this does not appear to be required as of yet.
Researchers in Zurich have been conducting a cohort study of people with acute HIV infection for two decades. We’ve added to the listing this month because cure-related results were presented at CROI 2023, describing predictors of time to HIV viral load rebound after ATI.
Two trials have shifted to the “completed” table:
- TITAN, which investigated the combination of a toll-like receptor 9 agonist, lefitolimod, with two bNAbs (3BNC117 and 10-1074).
- AELIX-003, a trial testing two therapeutic HIV vaccines (MVA.HTI and ChAdOx1.HTI) combined with the toll-like receptor 7 agonist vesatolimod.
Results from both studies were reported at CROI 2023 (see abstracts 136 and 443) and will be included in our forthcoming coverage of the conference.
Also added to the completed table is ATN 137, a study of youth initiating ART during either acute or chronic HIV infection sponsored by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN). The addition was prompted by the reporting of results related to the HIV reservoir and immune responses at CROI 2023.
The company Immunocore has sponsored a phase I trial of a novel approach that aims to redirect the attentions of T cells targeting other antigens toward the elimination of HIV-infected cells (T-cell receptor-based bispecifics). The trial does not appear to have been entered in online registries but has now been added to the completed table because results were presented at CROI 2023. A larger, registered trial is ongoing.
Disappointingly — and like too many other CROI 2023 abstracts — the Immunocore report refers to study participants as “subjects” and provides no demographic information whatsoever. TAG has previously collaborated with AIDS Action Baltimore, AVAC, NASTAD, and the Federal AIDS Policy Partnership Research Working Group to write to CROI about the lack of reporting of participant demographic information, and it’s frustrating to see the problem continue. A broader community sign-on letter to CROI is now being planned.
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