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Inflammation and Co-Infections in D²EFT

NCT ID: NCT04183738

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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HIV IL-6 EBV CMV HHV8 HPV inflammation co-infections opportunistic infections AIDS and non-AIDS defining cancers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Observational cohort nested within the parent open label phase III/IV randomised controlled trial of simplified second-line therapy, D²EFT.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SOC

darunavir/ritonavir 800/100mg + 2 NRTIs po od

Group Type ACTIVE_COMPARATOR

NRTIs

Intervention Type DRUG

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.

Darunavir

Intervention Type DRUG

800mg tablet by mouth once daily for 96 weeks.

Ritonavir

Intervention Type DRUG

100mg tablet by mouth once daily for 96 weeks.

DOL

darunavir/ritonavir 800/100mg + dolutegravir 50mg po od

Group Type EXPERIMENTAL

Darunavir

Intervention Type DRUG

800mg tablet by mouth once daily for 96 weeks.

Ritonavir

Intervention Type DRUG

100mg tablet by mouth once daily for 96 weeks.

Dolutegravir

Intervention Type DRUG

50mg tablet by mouth once daily for 96 weeks.

D2N

dolutegravir 50mg + tenofovir + emtricitabine or lamivudine po od

Group Type EXPERIMENTAL

NRTIs

Intervention Type DRUG

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.

Dolutegravir

Intervention Type DRUG

50mg tablet by mouth once daily for 96 weeks.

Interventions

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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.

Intervention Type DRUG

Darunavir

800mg tablet by mouth once daily for 96 weeks.

Intervention Type DRUG

Ritonavir

100mg tablet by mouth once daily for 96 weeks.

Intervention Type DRUG

Dolutegravir

50mg tablet by mouth once daily for 96 weeks.

Intervention Type DRUG

Other Intervention Names

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Nucleoside/Nucleotide Reverse Transcription Inhibitors Prezista Norvir Tivicay

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederick National Laboratory for Cancer Research

UNKNOWN

Sponsor Role collaborator

UNITAID

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role collaborator

Janssen Pharmaceutica

INDUSTRY

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Polizzotto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute, UNSW Sydney, Australia

Other Identifiers

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18Q065

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019-10-i2-DEFT

Identifier Type: -

Identifier Source: org_study_id