HIV-1 Infection Clinical Trial
Official title:
A Double-blind Placebo Controlled Immunogenicity Study of Vacc-4x + Lenalidomide Versus Vacc-4x With an Initial Open-label Dose Escalation Assessment of Lenalidomide in HIV-1-infected Subjects on Antiretroviral Therapy (ART).
During the course of HIV infection the number of CD4 cells decreases, resulting in a reduced immunological response and ultimately immune deficiency. Vacc-4x is a peptide-based HIV immunotherapy and the primary objective is to strengthen the immune system's response to HIV p24. By adding Lenalidomide, an immunomodulatory agent, as a supporting drug, it is anticipated that the effect of Vacc-4x might be enhanced.
Human immunodeficiency virus (HIV) infects the CD4 subset of T-cells that are critical for
initiating immune responses to infection. The level of CD4 cells in the blood is a marker of
a patient's immunological status. The number of CD4 cells decreases in the course of the HIV
infection and results in a reduced immunological response and eventually immune deficiency.
Vacc-4x is one of the few peptide-based therapeutic vaccines tested, and consists of four,
slightly modified HIV Gag p24 consensus peptides. Vacc-4x was first tested by intradermal
injections using GM-CSF as adjuvant. A recent multinational placebo-controlled study found
improvement of vaccine-specific T cell immunity and decrease in viral loads (presented at
the AIDS vaccine 2011 conference, Bangkok).
Lenalidomide (CC-5013) is a substance in the class of immunomodulatory agents. The
lenalidomide mechanism of action includes anti-neoplastic, pro-erythropoietic, and
immunomodulatory properties. Lenalidomide inhibits proliferation of certain hematopoietic
tumor cells, enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases
the number of NK T cells.
The anti-HIV p24 immune response resulting from Vacc-4x immunization could in combination
with ART potentially improve immune reconstitution in patients who have not fully regained a
healthy CD4 level (> 600 x106/L). Adding the immunomodulatory agent Lenalidomide (CC-5013)
to Vacc-4x immunization could enhance the immune response to Vacc-4x and further strengthen
immune reconstitution.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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