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.

Click here for more details

Calimmune Initiates HIV Stem Cell Study at Two California Research Sites

(Los Angeles, CA) -- The HIV gene medicines company Calimmune announced today that the first patient has 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 the 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 lab of Nobel Laureate Dr. David Baltimore and by Calimmune.

In the study, 12 HIV-positive participants will be infused with their own T cells and stem cells (hematopoietic stem cells, HSC), which have been modified to block the HIV receptor CCR5, and to prevent HIV fusion. The procedure is designed to prevent the virus from entering and damaging protected cells. The dual approach used in the study is designed to reduce the possibility that HIV can develop resistance to the procedure.

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 any antiretroviral agent.  In addition to routine clinical and laboratory assessments to monitor general health and HIV infection, the study will monitor the presence of Cal-1 protected cells in various cell types in the blood and lymphoid tissue. Other analyses will monitor the safety of Cal-1. The first patient was treated in the study in late June. Data from this study are expected in 2015.

All participants in the study’s three arms will receive the Cal-1 gene transfer. Participants in two of the three study arms will also receive different doses of a preconditioning drug known as busulfan, which may 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 development,” said Calimmune Chief Executive Officer Louis Breton.  “We are optimistic that 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 sites 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. For more information, visit www.clinicaltrials.gov.

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."

http://www.aidsmap.com/page/2692244/

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."


http://www.virtual-strategy.com/2013/07/01/argos-therapeutics-announces-plans-hiv-eradication-study