Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients

Inclusion criteria

• Patient is ≥ 18 years of age
• Voluntarily signed informed consent
• Patient is male, or female with negative pregnancy test prior to enrolment
• Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA before cART)
• Patient must be on stable treatment with cART for at least 6 months (cART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents)
• Nadir CD4+ cell counts must be above or equal to 350 cells/μl (1 or 2 occasional determinations below 350 will be allowed)
• Current CD4+ cell count must be at least 450 cells/μl
• HIV-RNA must be below 50 copies/ mL for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/mL are permitted)

Exclusion criteria

• Treatment with a non-cART regimen of antiretroviral agents prior to the start of cART;
• History of a CDC class C event (see Appendix V);
• Patient is female and has a positive pregnancy test or the wish of pregnancy:
• Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
• Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
• Use of anti-coagulant medication;
• Use of any investigational drug during the 90 days prior to study entry;
• Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy EudraCT No. 2014-004591-32 33 Protocol version 1.1, dated 10 February 2015
• Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
• Active hepatitis C virus or hepatitis B virus co-infection
• Non-subtype B HIV infection