Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART)
Condition: HIV-1 Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Lenalidomide; Lenalidomide placebo; Vacc-4X; rhuGM-CSF
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A; Capsules are identical to the active Lenalidomide capsules used.; Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.; Granulocyte macrophage colony stimulating factor as a local adjuvant
Other intervention name(s): Lenalidomide capsule; placebo; Combination of Vacc-10, Vacc-11, Vacc-12 and Vacc-13.; Leukine®
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CD4; Clinical trial; Dose escalation assessment lenalidomide; Human immunodeficiency virus-1 (HIV-1); HIV; Immunomodulatory; Infection; Lenalidomide; Phase I/II; Vaccine; Vacc-4x