NEAT Long Term
Research type
Research Study
Full title
An audit of outcomes of NEAT 001 / ANRS 143 participants
IRAS ID
222359
Contact name
Anton Pozniak
Contact email
Sponsor organisation
University Hospital of Nantes
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
The NEAT 001 study (36198) was designed to compare the efficacy and safety of two different combinations of antiretroviral drugs in adults with HIV who had never taken drugs to treat their HIV infection across 78 clinical sites over 15 countries.
The 2 regimens compared were a standard combination of 2 NtRTI of emtricitabine/tenofovir disoproxil plus ritonavir-boosted darunavir and a dual combination of raltegravir plus ritonavir-boosted darunavir.
Patients were recruited between August, 2010, and September, 2011. Although NEAT 001 study had a median follow-up of 123 (112-133) weeks, there is no information to date on long term outcome of patients started on a NtRTI-sparing regimen with a combination of an integrase strand transfer inhibitor and a ritonavir-boosted protease inhibitor. Tolerability and safety was comparable between both groups, but ancillary studies, still ongoing, suggest a better renal safety profile in the NtRTI sparing regimen as well as less decrease in bone mineral density and less impact on bone turnover markers. On the other side, the NtRTI-sparing combination of raltegravir plus ritonavir-boosted darunavir is associated with emergence of integrase resistance-associated mutations at virologic failure, while in the emtricitabine/tenofovir, no resistance mutations emerged at failure
The objective of this non interventional audit is to collect, from most of the sites involved with the conduct of the NEAT 001 study , prospective and retrospective information on clinical progression (AIDS and non aids-serious events), occurrence of significant (grade 4, death) adverse events) or pregnancy, as well as data on CD4 cell counts, HIV RNA and creatinine, change in antiretroviral therapy, reasons of changes and data on resistance, if available.
Only data collected or present in the patents’ charts and/or electronic medical records will be used for this audit.
REC name
London - South East Research Ethics Committee
REC reference
17/LO/2005
Date of REC Opinion
6 Dec 2017
REC opinion
Favourable Opinion