Assessment of the therapeutic properties of the VAC-3S immunoprotective vaccine when combined with standard antiretroviral therapy (ART) in the course of HIV-1 infection. A European multicenter, randomized, double-blind, placebo-controlled, phase II study

InnaVirVax SA0 sites90 target enrollmentSeptember 26, 2013

Overview

No summary available.

Registry

who.int

Start Date

September 26, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

InnaVirVax SA

•1\. Documented HIV\-1 infection,
•2\. Adults \> 18 and \< 60 years of age,
•3\. Able and willing to comply with the protocol, including availability for all scheduled study visits,
•4\. Provided a signed written informed consent,
•5\. Meets study screening physical, medical history and laboratory assessments (defined below),
•6\. On stable antiretroviral therapy that is consistent with the current standard of care for at least 12 months prior to study screening,
•7\. Plasma HIV RNA \< 50 cps/mL during the previous 12 months,
•8\. CD4\+ T cell count at screening \> 200 and \< 500 cells/mm3,
•9\. Adequate hematology, biochemistry, and metabolic blood tests
•defined as being less than grade 2 according to the Division of AIDS Adverse Events (See Appendix 23\.1\), except for the

•1\. Not meeting all of the inclusion criteria listed above,
•2\. Administration of any investigational drug or device within 28 days prior to screening,
•3\. Prior history of an AIDS\-defining event in the past 5 years,
•4\. Active co\-infection with either HCV or HBV or any other active viral hepatitis co\-infection,
•5\. Any acute or clinically significant infections within the past month,
•6\. Known allergy or intolerance to components of VAC\-3S as documented through medical records or via patient interview,
•7\. Chronic active liver disease as documented by any of the following laboratory assessments: ultrasound, clinical assessment, liver biopsy or equivalent non\-invasive methods,
•8\. Receipt of any known vaccinations within the past 1 month prior to screening,
•9\. Receipt of any agent in the past 12 months that exerts a known immunological effect (e.g. includes but not limited to IL\-2, IL\-7, growth hormone…),
•10\. Patients with Insulin Dependent Diabetes Mellitus, patients receiving anti\-diabetic treatment, anticoagulants (excluding daily baby\-dose” aspirin) or daily NSAIDs within one week of study enrollment,