Imperial College London
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DrSarahJoseph

Faculty of Medicine, Department of Infectious Disease

Clinical Immunologist
 
 
 
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Contact

 

s.joseph

 
 
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Location

 

457Medical SchoolSt Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Jentsch:2012:10.1371/journal.pone.0042322,
author = {Jentsch, U and Lunga, P and Lacey, C and Weber, J and Cairns, J and Pinheiro, G and Joseph, S and Stevens, W and McCormack, S},
doi = {10.1371/journal.pone.0042322},
journal = {PLOS One},
title = {The implementation and appraisal of a novel confirmatory HIV-1 testing algorithm in the microbicides development programme 301 trial (MDP301)},
url = {http://dx.doi.org/10.1371/journal.pone.0042322},
volume = {7},
year = {2012}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - We describe the application of a novel HIV confirmatory testing algorithm to determine the primary efficacy endpoint in alarge Phase III microbicide trial. 9385 women were enrolled between 2005 and 2009. Of these women, 537 (6%) had at leastone positive HIV rapid test after enrolment. This triggered the use of the algorithm which made use of archived serum andBuffy Coat samples. The overall sample set was.95% complete. 419 (78%) of the rapid test positive samples wereconfirmed as primary endpoints using a combination of assays for the detection of HIV-specific antibodies (EIA’s andWestern Blot), and for components of the virus itself (PCR for the detection of nucleic acids and EIA for p24 antigen). 63(12%) cases were confirmed as being HIV-positive at screening or enrolment and 55 (10%) were confirmed as HIV negative.The testing algorithm confirmed the endpoint at the same visit as that of the first positive rapid test in 90% of cases and atthe time of the preceding visit in 10% of cases. Of the 63 cases which were subsequently confirmed to be HIV-1 positive ator before enrolment, 54 specimens contained no detectable HIV antibodies at screening or enrolment. However, 43 werepositive using an EIA which detects both HIV antigen and antibody and also had a positive p24 antigen or HIV PCR test,which was highly suggestive of acute infection. There were 6 unusual cases which had undetectable HIV-1 DNA or RNA. In 4of the 6 cases the presence of HIV-1-specific antibodies was confirmed by Western Blot. One of these cases with anindeterminate Western Blot was a previous vaccine trial participant. The algorithm served the objectives of the study welland can be recommended for use in determining HIV as an endpoint in clinical trials.
AU  - Jentsch,U
AU  - Lunga,P
AU  - Lacey,C
AU  - Weber,J
AU  - Cairns,J
AU  - Pinheiro,G
AU  - Joseph,S
AU  - Stevens,W
AU  - McCormack,S
DO  - 10.1371/journal.pone.0042322
PY  - 2012///
SN  - 1932-6203
TI  - The implementation and appraisal of a novel confirmatory HIV-1 testing algorithm in the microbicides development programme 301 trial (MDP301)
T2  - PLOS One
UR  - http://dx.doi.org/10.1371/journal.pone.0042322
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000308638700004&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/50822
VL  - 7
ER  -
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