DNA vaccination in HIV-vertically infected children - PEDVAC

Swedish Institute for Infectious Disease Control0 个研究点开始时间: 2008年7月15日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1.Aged between 4 and 16 years
•2.Females, who are willing not to father a child for the duration of the study.
•3.Male participants will be cautioned of the unknown hazard to a foetus and advised to not have sexual relations for the duration of the study.
•4.HIV infection detected by two serological and HIV plasma RNA tests
•5.On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months
•6.Stable CD4 value above 400 cells/mm3 or 25% in the last 12 months of follow-up
•7.Viral isolate pre ART available is preferable but not mandatory
•8.Able to give informed consent
•9.Availability for follow-up for planned duration of the study
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Patients with ongoing infection(s) other than HIV
•2.Treatment with steroids, systemic or local at the immunizing sites, one month before or during the trial
•3.Patients with signs of autoimmune diseases
•4.Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ml, platelets <150,000/ml
•5.Patients on any immune modulating or investigational drug
•6.Anamnestic allergy to kanamycin or plasmid gene products

发起方