Promising new treatment that could cure HIV starts Phase I trials
The AIDS Clinical Trials Unit (ACTG), the world’s largest HIV research network, have announced the launch of a new study that will evaluate to promising treatments that have the potential to cure HIV.
The study will focus on whether N-803 (Anktiva, a clinical-stage biological drug) can control HIV on its own or together in combination with broadly neutralising antibodies (bNAbs) once study participants have stopped standard antiretroviral therapy (ART) under careful supervision.
In preclinical and clinical studies N-803 demonstrated three modes that could help the immune system eliminate HIV reservoirs and/or control viral rebound:
- Reversing the latent period of HIV (the lack of HIV replication in long-lived immune cells) allowing the immune system to detect it.
- Activation of NK cells and T cells, elements of the immune system that specialise in targeting and destroying infected cells.
- Allowing the NK cells and T cells to move to lymphoid tissues, where they can meet and possibly destroy infected cells.
Over two years the study will follow 46 people living with HIV who have been taking standard ART. Before the study begins, participants will undergo eukapheresis (a medical procedure in which white blood cells or white blood cells are separated from the blood) to measure HIV reservoirs.
Participants will be divided into two groups; one will receive only N-803 and the other group will receive a combination of N-803 and bNAbs.
After treatment participants will be monitored closely for 100 weeks to identify whether they need to restart ART or not.
"Clinical trials of HIV drugs remain a fundamental element of the ACTG research program. We believe this study will provide important information as we continue to pursue our ultimate goal of finding a cure for HIV and making it available to millions of people living with HIV worldwide.” – Judith Currier, MD, MS, Chair of ACTG, UCLA