Immune Response to Bivalent or Tetravalent Human Papillomavirus Vaccine in HIV infected Adults - HIPAVAC study

Department of Infectious Diseases - Aarhus University Hospital0 个研究点开始时间: 2011年5月31日最近更新: 2014年2月24日

试验速览

暂无简介。

•1) Written informed consent and authority statement provided according to local regulatory and ethical practice using a participant information sheet and informed consent form approved by the responsible Ethics Committee.
•2) Male or female participants = 18 years.
•3) HIV-seropositive individuals.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1) Pregnancy as determined by a positive urine beta-hCG (if female)
•2) Participants unwilling to use reliable contraception for the duration of the trial (if female). Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral and transdermal delivery, surgical sterilization, vaginal ring, intrauterine device, abstinence and post-menopause (if female).
•3) Currently breast-feeding (if female)
•4) Viral load (HIV-RNA) > 50 copies/mL if on HAART
•5) Previous enrolment in the study
•6) Any medical, psychiatric, social or occupational condition that, in the judgement of the Principal Investigator (PI) would interfere with the evaluation of study objectives (such as severe alcohol abuse, severe drug abuse and dementia)
•7) Unable to follow protocol regimen
•8) Previous HPV-vaccination
•9) Planned participation in other vaccination trials during the time of the study.
•10) Cancer, autoimmune disease or chronic administration of systemic immunosuppressive drugs.

发起方

Department of Infectious Diseases - Aarhus University Hospital