Inflammation and Co-Infections in D²EFT

• Status: Withdrawn
• Trial end date: 2022-12-19
• Target enrollment: 0
• Participant gender: All

Summary

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Darunavir; Dolutegravir; Ritonavir

Criteria

Inclusion Criteria:

• Fulfil the eligibility criteria for D²EFT randomisation;

• Being able to give a written informed consent for the i2-D²EFT sub-study.

Exclusion Criteria:

• Unwilling to comply with the i2-D²EFT protocol requirements.