Combination Vaccination and Broadly Neutralising Antibody Therapy in HIV
Trial Parameters
Brief Summary
There is no cure for HIV infection. Antiretroviral therapy (ART) is widely available but requires daily, life-long intake. This can cause issues around side-effects, resistance, adherence and stigma. A new therapy, broadly neutralising antibodies, (bNAbs), may work as well as ART and may last longer - one dose can last six months. bNAbs appear to first target HIV viruses, then drive a protective immune response conferring long-term control, called the vaccinal effect. AbVax is a clinical trial to understand this effect and how to enhance it to give the strongest possible long-term protection for people living with HIV (PWH). The investigators are studying whether a combination of vaccines that attack HIV, a short period of treatment interruption induced viraemia (TIIV - stopping ART for a few weeks to allow a small amount of virus to return to the bloodstream) and bNABs will produce the most sustained immune protection.
Eligibility Criteria
Inclusion Criteria: * PWH aged ≥18 to ≤64 years old at screening * Able to give informed written consent including consent to long-term follow-up * Willing and able to comply with visit schedule and provide blood sampling * Willing to consent to their HIV care team being informed of their participation and sharing relevant clinical information * Stable on oral ART with suppressed undetectable HIV pVL 'target not detected' (TND) using local assays for ≥ 1 years (a single viral load measurement \>50 but \<500 copies/ml during this time period is allowable) * No evidence of viral insensitivity to GS-2872 based on proviral sequencing * No significant co-morbidities according to the investigator's opinion * Nadir CD4 \>200 cells/µl unless treatment commenced during documented acute seroconversion * Current CD4 count \>500 cells/µl or CD4:CD8 ratio \>1.0 * On integrase inhibitor (INSTI) or boosted protease inhibitor (bPI) based regimen at time of randomisation. If previously on non-nucleosid