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Inflammation and Co-Infections in D²EFT

NCT04183738 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-11-10

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

NRTIs

In SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection. In D2N arm, NRTIs are predetermined.

DRUG

Darunavir

800mg tablet by mouth once daily for 96 weeks.

DRUG

Ritonavir

100mg tablet by mouth once daily for 96 weeks.

DRUG

Dolutegravir

50mg tablet by mouth once daily for 96 weeks.

Sponsors & Collaborators

  • Frederick National Laboratory for Cancer Research

    collaborator UNKNOWN

  • UNITAID

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • ViiV Healthcare

    collaborator INDUSTRY

  • Janssen Pharmaceutica

    collaborator INDUSTRY

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • Mark Polizzotto, MD, PhD · Kirby Institute, UNSW Sydney, Australia

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-12-19
Completion
2022-12-19

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183738 on ClinicalTrials.gov