At a glance
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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).
In Brief
A Phase 2 clinical trial evaluating Lenalidomide, Lenalidomide placebo, and 2 other interventions for HIV-1 Infection. Completed, enrolled 36 participants across 4 sites.
Detailed 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.
Study Details
Timeline
Interventions
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