Active immunotherapy against HIV during highly active anti-retroviral therapy followed by repeated treatment interruptions, VAC 09. - Vac 09

Swedish Institute for Infectious Disease Control0 个研究点目标入组 30 人开始时间: 2006年1月9日最近更新: 2012年10月29日

适应症

试验速览

暂无简介。

•1.Aged between 18 and 60 years
•2.HIV infection detected by two serological and/or HIV plasma RNA tests
•3.On HAART for at least 6 months with less than 50 copies/ml of plasma HIV-1 RNA at two determinations over 3 months
•4.Current CD4 count above 400
•5.CD4 count nadir >200
•6.Viral isolate pre ART available is a preferable but not mandatory
•7.Willing to consider stopping HAART repeatedly.
•8.Willing to conform to a low alcohol intake (maximum of one glas per day)
•9.Able to tolerate didanosine and hydroxyurea
•10. Willing to change their HAART to exclude NNRTI and stavudine
•11.Able to give informed consent
•12.Availability for follow-up for planned duration of the study
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Pregnancy
•2.Patients with ongoing infection(s) other than HIV.
•3.Prior or current panceatitis or history of alcohol abuse.
•4.Ongoing neuropathy and history of more than grade 1 neuropathy.
•5.History of mutations to more than one class of anti-retroviral drugs or switched drugs more than once due to failure.
•6.Sun or solarium exposure at the immunizing sites one month before or during the trial.
•7.Cortisone treatment, systemic or local at the immunizing sites, one month beforte or during the trial.
•8.Patients with signs of autoimmune diseases
•9.Patients with creatinine > 2mg/dl, Hb < 12g/dl, leukocytes < 3,000ml, platelets <150,000/ml and LFT > 5x upper limit of normal
•10.Patients on any immune modulating or investigational drug
•11.Anamnestic allergy to kanamycin, plasmid gene products

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