HIV-1 Infection Clinical Trial
Official title:
International, Multicenter, Randomized, Non-comparative Controlled Study of Therapeutic Intensification Plus Immunomodulation in HIV-infected Patients With Long-term Viral Suppression
Viral eradication in selected HIV-infected patients is possible with intensive antiretroviral therapy plus immunomodulation
The overall strategy of the ERAMUNE 01 Trial is to treat selected patients with an optimal
synergistic antiretroviral regimen plus one or more immunomodulating agents. Among
immunomodulating treatments the candidates include therapies from two functional classes: 1)
agents that target actively replicating cells and 2) agents activating latently infected
cells31.
The novelty of this approach is three-fold: first, the use of highly potent antiretroviral
therapy combining drugs with different HIV enzymes targets or receptors and different
penetrations in cells, with the aim to suppress virus to truly undetectable levels as
measured by the most sophisticated viral quantification techniques; secondly, the addition
of an immunomodulatory therapy that specifically targets viral reservoirs to this
intensification strategy; and lastly, the rigorous selection of patients having already a
low HIV reservoir as measured by peripheral blood HIV DNA content. To our knowledge, this
type of strategy has not been implemented. We believe this strategy is feasible.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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