Investigation of a novel intervention in Acute HIV Infection (AHI)
Research type
Research Study
Full title
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
IRAS ID
94589
Contact name
Julie Fox
Sponsor organisation
Guy's & St. Thomas' NHS Foundation Trust
Eudract number
2011-001982-42
ISRCTN Number
n/a
Research summary
This multi-centre, randomised pilot study investigates the effect of intravenous immunoglobulin combined with standard of care, Highly Active Antiretroviral Therapy (HAART), to individuals with very recent HIV infection (also called acute HIV infection) to reduce the HIV latent reservoir. Individuals with acute HIV infection will start HAART as routine care. At week 20 (when the HIV viral load is undetectable) they will be randomised to either receiving a 5 day course of intravenous immunoglobulin or not. They will then be followed up for a total of 48 weeks and the size of the HIV reservoir between the two groups compared. Other factors predictive of disease outcome such as CD4 count, HIV viral load, and immune activation will also be compared. There are two sub studies; the first is investigating the effect of intravenous immunoglobulin on the gut. This requires a rectal biopsy immediately before and after the course of immunoglobulin. The second sub-study is investigating the speed of viral rebound after stopping HAART at week 48. The co-applicants have years of successful collaboration of running clinical trials in acute HIV infection which have changed National Guidelines. Through this clinical trial we will establish a platform facilitating future UK HIV ??cure?? research, with international colleagues, including renowned basic scientists, vaccine experts and clinical researchers working to design and implement novel trials.
REC name
London - Hampstead Research Ethics Committee
REC reference
12/LO/0977
Date of REC Opinion
26 Jun 2012
REC opinion
Favourable Opinion