Inflammation and Co-Infections in D²EFT (i2-D²EFT)

K

Kirby Institute

Status and phase

Withdrawn
Phase 4

Conditions

HIV-infection/Aids
Human Papilloma Virus
Human Herpesvirus 8 Infection
Cytomegalovirus Infections
Human Herpesvirus 4 Infections

Treatments

Drug: Ritonavir
Drug: Darunavir
Drug: NRTIs
Drug: Dolutegravir

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT04183738
18Q065 (Other Grant/Funding Number)
2019-10-i2-DEFT

Details and patient eligibility

About

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.

Full description

i2-D²EFT substudy an observational cohort nested within the parent open label phase III/IV randomised controlled trial of simplified second-line therapy, D²EFT (NCT03017872). Participants consenting to D²EFT study will be randomised within the three arms: either ritonavir-boosted darunavir plus two nucleosides or dolutegravir plus two predetermined nucleosides (tenofovir disoproxil fumarate plus lamivudine or emtricitabine) or ritonavir-boosted darunavir plus dolutegravir. Enrolment into the i2-D²EFT substudy is voluntary and optional for participants in D²EFT. Parameters relevant to i2-D²EFT substudy including demographics, arm of randomised ART, HIV history, physical examination, immunological and virological results, episodes of co-infections and adverse events due to any infection or malignancies at required time points will be collected as part of D²EFT study. Substudy specific assessments performed at baseline and at weeks 48 include sample collection for IL-6 dosage plus EBV/CMV/HHV8 testing, and optional anal/cervical HPV screening.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

SOC
Active Comparator group
Description:
darunavir/ritonavir 800/100mg + 2 NRTIs po od
Treatment:
Drug: NRTIs
Drug: Darunavir
Drug: Ritonavir
DOL
Experimental group
Description:
darunavir/ritonavir 800/100mg + dolutegravir 50mg po od
Treatment:
Drug: Dolutegravir
Drug: Darunavir
Drug: Ritonavir
D2N
Experimental group
Description:
dolutegravir 50mg + tenofovir + emtricitabine or lamivudine po od
Treatment:
Drug: Dolutegravir
Drug: NRTIs

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems