ACTG has launched A5374, a Phase I/IIa clinical trial to evaluate the safety, tolerability, and antiviral effect of a combination of three novel immune-based therapies aimed at HIV cure.

The A5374 (Triple Immune Strategy for HIV Remission) study will test a regimen including therapeutic T-cell vaccines, two broadly neutralising antibodies (bNAbs), and an immune booster in participants who began antiretroviral treatment (ART) during early acute (early) HIV infection.

The A5374 trial represents a step towards a potential cure by testing whether the immune system can manage HIV in the absence of ART for weeks or months.

ACTG said the trial will enroll 45 participants aged over 18 years, who initiated ART within 28 days of their acute HIV diagnosis.

The study is planned to last up to approximately two years for each participant, who will continue their HIV medication alongside the trial regimen or a placebo.

The regimen comprises a T-cell vaccine regimen (vaccines vectored by replication-deficient chimpanzee adenovirus ChAdOx1 and poxvirus MVA, each containing six small fragments of HIV); broadly neutralising antibodies; and vesatolimod, a TLR7 agonist.

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After 16 months, participants will undergo a closely monitored pause in ART to assess the treatment’s effect on viral control.

The A5374 trial will compare the duration of viral control off ART between the treatment and placebo groups.

ACTG chair Judith Currier said: “We expect that controlling HIV in the absence of ART will require a combination of novel treatments to decrease the number of cells harbouring HIV and simultaneously stimulate the immune system to keep the virus from replicating.

“A5374 is a pivotal trial and we are hopeful that it will provide us with important insights into how to boost the immune system so that it can control HIV.”

ACTG plans to conduct the trial at up to ten sites in the US and Brazil, with sponsorship from the National Institute of Allergy and Infectious Diseases (NIAID).

Besides supplying the T-cell vaccines for the trial, the University of Oxford is carrying out endpoint assays. Gilead Sciences is supplying the bNAbs and TLR7 agonist.

Last year, ACTG reported results from the REPRIEVE trial of Pitavastatin to prevent cardiovascular disease in HIV infection.