The Future of HIV Treatment is Here: Once-a-Month Injections to Replace Daily Oral Medications

A combination of antiretroviral drugs in long-acting nanosuspension formulations achieved adequate blood levels and appeared safe in HIV negative study volunteers, offering the potential for a maintenance or PrEP option that could be taken once monthly, researchers reported at the 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) this week in Kuala Lumpur.
While modern antiretroviral therapy is highly safe and effective, agents that could be administered less frequently would improve convenience for people with HIV. A long-acting option could prove especially attractive for maintenance therapy once viral load is suppressed, or for pre-exposure prophylaxis (PrEP) in HIV negative people.

Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

(Los Angeles, CA) —
HIV gene medicines company Calimmune announced
first patient
begun treatment in
a Phase I/II
clinical trial designed
to determine
whether a pioneering genetic medicine approach can help to protect
individuals infected with
HIV from the effects of
virus. The study, “Safety Study of a Dual
Anti-HIV Gene Transfer Construct to Treat
HIV-1 Infection
,” utilizes a gene medicine
called Cal-1, developed in the
of Nobel
Laureate Dr. David
Baltimore and
by Calimmune.
In the
study, 12 HIV-positive participants will
be infused
with their
T cells and stem
cells (hematopoietic stem cells,
HSC), which have
been modified to
block the
receptor CCR5, and to prevent HIV fusion. The procedure
is designed to prevent the
virus from entering and damaging
cells. The dual
approach used in
the study
designed to reduce the
possibility that HIV
can develop resistance to the
The goal of the study is to
assess the safety, feasibility, and
tolerability of Cal-1
in HIV- infected
individuals who have previously been
on highly active antiretroviral therapy
(HAART) but
are not currently taking
antiretroviral agent.  In addition to
clinical and laboratory assessments to monitor general health
and HIV infection, the
study will
monitor the presence
of Cal-1
protected cells in
cell types in the blood and
tissue. Other analyses
will monitor the safety of Cal-1. The first patient was
treated in the study in
June. Data from
this study are expected in 2015.
All participants in the study’s three arms will
the Cal-1 gene transfer.
Participants in
of the three study arms will
receive different doses of a preconditioning drug known as busulfan,
make the
therapy more effective.
“This study is an early but important step in an emerging area of scientific exploration,
representing the culmination of more than a
decade of research and
said Calimmune Chief Executive Officer Louis Breton.  “We are optimistic
what we
learn from this study may bring
us closer to the day when a one-time treatment
could provide an alternative to
a lifetime
of antiretroviral therapy.”
The study has been partially funded by the California Institute for Regenerative Medicine (CIRM).  The study will take place at clinical trial
in Los Angeles
and San Francisco,
Calif., under the
direction of Principal Investigators Ron Mitsayasu, M.D.,
of UCLA and Jacob P. Lalezari, M.D., of Quest Clinical Research.
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Two More Patients Are Cured of HIV- And This Time With A Less Complex Regimen

“Both the surviving patients had been receiving prolonged antiretroviral therapy and received stem cell transplants with a reduced-intensity conditioning regimen of chemotherapy designed to eradicate the cancer and eliminate the existing bone marrow. In the case of the two patients under investigation, the conditioning regimen did not include radiotherapy and it did not eliminate the residual lymphocyte population. In contrast, the ‘Berlin patient’ received a much more aggressive regimen which eliminated existing bone marrow cells.
The transplants also differed from the ‘Berlin patient’ because they did not come from donors with genetic resistance to HIV infection (a CCR5 delta 32 mutation), so the cells were susceptible to HIV infection.”
“To date, Patient A has been off treatment for seven weeks and Patient B for 15 weeks. Neither patient has yet shown any evidence of viral replication by RNA testing or any evidence of HIV DNA in PBMCs. Week-six testing of larger blood samples from Patient B has similarly failed to detect HIV.
Neither transplant recipient showed any evidence of HIV-specific immune responses.”

New HIV Eradication Study: The Use of a Personalized ImmuneTherapy (AGS-004) with a Reservoir Activating Agent

Argos Therapeutics Announces Plans for HIV Eradication Study 

“To create AGS-004, ribonucleic acid (RNA) is isolated from HIV particles obtained from patients, and dendritic cells are generated from a single leukapheresis procedure. Selected RNAs are then used to “program” the dendritic cells with the patient-specific payload to trigger an immune response against the patient’s HIV infected cells. These patient-specific, antigen-loaded dendritic cells are formulated into a ready-to-use, intradermal injection.
In Argos Therapeutics’ proposed study, AGS-004 will be combined with one or more agents that are capable of activating the latent HIV reservoir thereby making infected cells ‘visible’ to the immune system. Once the latent HIV has been activated, AGS-004 will be able to identify and kill HIV infected cells, with no added toxicity. The proposed Phase 2 study will aim to treat HIV patients who are currently taking antiretroviral therapy (ART), to evaluate the impact on decreasing or potentially eradicating the infected cells.”