Investigation of a novel intervention in Acute HIV infection (AHI) on long term latent HIV reservoir size: A pilot study of antiretroviral therapy plus immunoglobulin in AHI - Investigation of a novel intervention in Acute HIV Infection (AHI)

Guy's & St. Thomas' NHS Foundation Trust0 个研究点目标入组 10 人开始时间: 2012年7月4日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1)Males and females aged between 18-65 years (inclusive).
•2)HIV antibody negative with p24/PCR DNA positive
•HIV antibody positive with a previous HIV negative test in the preceding 3 months
•Health Protection Agency HIV incident virus assay (estimating virus acquired within 3 months)
•3)Ability and willingness to provide informed consent
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1)HIV negative
•2)Pregnancy or lactating: at enrolment, randomisation or during study period as there is no data on IVIG in pregnant HIV+ women.
•3)Patient unable or unwilling to comply with trial protocol
•4)Known hypersensitivity to the active substances or to any of the excipients of the IMP
•5)Current use or likely to require use of concomitant medication with known
•interactions with HAART regimen in accordance with SmPCs.
•6)Hep B sAg positive at screening or prior to starting antiretroviral therapy (ARV)
•7)Documented active Hepatitis C.
•8)Previous documented pulmonary embolism (PE), deep vein thrombosis (DVT), myocardial infarction (MI) or cerebrovascular accident (CVA)
•9)Women of childbearing potential unwilling to use barrier method contraception (condoms)
•10) Sexually active males with female partners of childbearing potential, unwilling to use barrier method contraception (condoms)
•11)Insulin dependant diabetes
•12)Documented bleeding disorders (for gut sub study participants only)

发起方

Guy's & St. Thomas' NHS Foundation Trust