HIV Infections Clinical Trial
Official title:
A Phase IIa Randomized, Placebo Controlled, Double Blinded Study to Evaluate the Safety and Immunogenicity of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy
iHIVARNA-01 is a novel therapeutic vaccine for the treatment of HIV-1-infected patients based on in vivo modification of DCs. It consists of HIVACAT-TriMix: mRNA encoding a mixture of APC activation molecules (CD40L, a constitutively active variant of TLR4 and CD70) and the HIV target antigens contained in HIVACAT to be administered through the intranodal route. iHIVARNA-01 aims to achieve the 'functional cure' of HIV infection, i.e. controlling viral replication in the absence of anti-retroviral therapy.
Objective: To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic
vaccine in HIV infected patients.
Study design and duration: Phase IIa, multicentre double-blind placebo controlled
intervention study. Each patient will be followed for 30 weeks. The study duration will be 38
weeks from inclusion of the first patient.
Sites: Erasmus MC, Rotterdam The Netherlands (sponsor), Hospital Clínic de Barcelona and
Institut de Recerca de la Sida - Caixa, Barcelona, Spain, Instituut voor Tropische
Geneeskunde Antwerp, Belgium and Vrije Universiteit Brussel/UZ Brussel, Belgium
Study population: Chronically HIV-1- infected patients under stable cART with plasma viral
load (pVL) ≤ 50 copies/ml and stable CD4+ T-cell counts ≥ 450/μl, aged 18 years or above.
Sample size: after recruitment and screening, 70 patients will be included and randomized to
one of the study-arms.
Intervention: One group (n=40) receives the HIVACAT-TriMix (300 microgram TriMix + 900
microgram HIVACAT) vaccine intranodally on three occasions with a two-week interval. One
control group (n=15) receives TriMix only (300 microgram TriMix) and one group (n=15)
receives saline intranodally on three occasions with a two-week interval. Two weeks after the
last vaccination cART treatment will be interrupted. If plasma virus is detectable, cART will
be re-initiated twelve weeks after treatment interruption. cART can always be re-initiated
for medical reasons, as judged by the clinical investigator.
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