HIV Specialist - June 2021 - 6

INFORMATION FOR HIV CARE PROVIDERS
IN
THE
NEWS
ACTG Launches Phase 1 Combination HIV Cure Study
THE AIDS CLINICAL TRIALS GROUP (ACTG), the
largest global HIV research network, announced the launch
of A5386, a phase 1 HIV cure study evaluating two promising
therapies. A5386 will study whether N-803 can control HIV
alone or together with combination broadly neutralizing
antibodies (bNAbs) after participants stop their antiretroviral
therapy (ART) and they are carefully monitored.
In pre-clinical and clinical research, N-803 (an IL-15
superagonist) has exhibited three activities that may help
the immune system eliminate HIV reservoirs
or control virus rebound. First, N-803 has
been shown to reverse HIV latency
(the process of no reproduction of
HIV within long-lived cells in the
immune system), allowing it to be
detected by the immune system.
Second, it activates NK cells and
CD8+ T-cells, two elements of the
immune system that specialize in
killing virus-infected cells. Finally, it
enables NK cells and CD8+ T-cells to
move to lymphoid tissues where they will
encounter and hopefully eliminate HIVinfected
cells.
The actions of bNAbs (or antibodies that neutralize
diff erent variants of HIV) are well-matched to that of
N-803. bNAbs neutralize HIV that is produced upon
reactivation, preventing new infections; target (label)
HIV-infected cells for destruction by NK cells; and may act
to boost CD8+ T-cell responses. A5386 will utilize an array
of virologic and immunologic tests to evaluate the degree
to which each of these expected activities are induced in
study participants. Ultimately, the study will test whether
this approach results in immune control of HIV when ART is
paused with careful monitoring.
" HIV cure clinical trials remain a fundamental element of
the ACTG's research agenda, " said ACTG Chair Judith Currier,
M.D., M.Sc., University of California, Los Angeles. " A5386
is particularly exciting as it marries two of the approaches
in the HIV cure research space with the most potential. We
believe this study will provide important insights as we
continue to pursue our ultimate goal of identifying a cure for
HIV and making it available to the millions of people living
with HIV around the world. "
A5386 is a phase 1, open-label, randomized study
evaluating the safety, tolerability, and effi cacy of N-803
both with and without combination bNAbs. It will enroll 46
people living with HIV (23 in each study arm) whose virus
has been suppressed by ART for approximately two
years, including at least 30 percent cisgender
women or transgender men. Participants
will undergo leukapheresis (a medical
procedure in which white blood cells,
or leukocytes, are separated from the
blood) to measure their HIV reservoirs
and a subset will undergo optional
lymph node fi ne needle aspirations to
assess the eff ect of N-803 on lymphoid
tissue. They will then be randomized to
one of two arms: N-803 alone or N-803
with combination bNAbs. After receiving
treatment, participants will stop taking ART
and will be followed closely to monitor for signs that
they need to restart ART. Most participants will be followed
for approximately 100 weeks after receiving treatment.
" Pre-clinical studies have shown that this approach
enables the immune system to control viral replication and
suggest that N-803 and bNAbs will have a complementary
eff ect on each other, " said A5386 Protocol Vice-Chair Richard
Brad Jones, Ph.D., Weill Cornell Medicine. " We hope A5386
will demonstrate whether this new approach can enable us to
safely decrease the amount of participants' HIV. "
A5386 is led by Timothy Wilkin, M.D., M.P.H. (Weill Cornell
Medicine), Marina Caskey, M.D., (The Rockefeller University)
and Dr. Jones. It is funded by the National Institute of Allergy
and Infectious Diseases (NIAID), part of the National Institutes
of Health (NIH), and N-803 is provided by ImmunityBio, Inc.
NIAID and collaborating NIH Institutes fund the ACTG.
6 JUNE 2021 HIVSPECIALIST WWW.AAHIVM.ORG
SHUTTERSTOCK/ MAXIM ERMOLENKO
http://WWW.AAHIVM.ORG

HIV Specialist - June 2021

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