i2-D²EFT substudy is an observational cohort nested within the parent D²EFT study
(NCT03017872). D²EFT goal is to compare the standard of care second-line antiretroviral
therapy in people living with HIV whose first-line non nucleoside reverse transcriptase-based
regimen failed, to two simpler regimens. Approximately 1,000 participants will be enrolled in
D²EFT.
Commencing a second-line ART is an important moment when the level of inflammation in
participants may be elevated due to first-line ART failure; this level of inflammation should
then decrease with the commencement of a new second-line treatment and would be expected to
normalise by 48 weeks of second-line treatment, if successful.
The investigators propose to study other factors which can influence the decrease of
inflammation. The investigators hypothesise that co-infections may play a role in persistent
inflammation. The key-infections of interest will be common frequent infections encounter
throughout the world: Human Herpes virus 8, Epstein-Barr virus, Cytomegalovirus and Human
papillomavirus, tuberculosis, malaria and other key opportunistic infections. Possible
changes of level of inflammation (using the serum level of Interleukin 6) in approximately
200 participants of the D²EFT study will be investigated and measured. The hypothesis is that
the presence of other infections than HIV may influence the level of inflammation in
participants in therapeutic success.
Phase:
Phase 4
Details
Lead Sponsor:
Kirby Institute
Collaborators:
Frederick National Laboratory for Cancer Research Janssen Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) UNITAID ViiV Healthcare