Toll-like receptor 9 augmentation of antiviral immune responses to enhance the immune cell-mediated killing of HIV infected cells leading to a better clearance of the infectio

Phase 1

• Conditions: HIV; MedDRA version: 19.0Level: LLTClassification code 10073675Term: HIV infection CDC category unspecifiedSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-005634-59-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-07
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

•Documented HIV-1 infection
•Age >18 years
•CD4+ T-cell count >350/µL at screening
•On cART (for a minimum of 12 months)
•Able to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnancy as determined by a positive urine beta-hCG (if female)
•Males or females who are unwilling or unable to use barrier contraception during sexual intercourse for the entire study period.
•Currently breast-feeding (if female)
•Viral load (HIV RNA) > 50 copies/mL
•Contraindication to receive MGN1703 as per current investigator brochure
•Presence of acute bacterial infection or undiagnosed febrile condition
•Concurrent chronic systemic immune therapy or immunosuppressant medication, including continuous systemic steroid treatment within the last 2 weeks prior to randomization
•Use of antibiotic therapy within the last 2 weeks prior to randomization
•Known HBV or HCV infection
•Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse, dementia)
•Unable to follow protocol regimen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified