Analysis of Oxidative Stress Biomarkers and Their Determi... | NCT05760495

Studies
Analysis of Oxidative Stress Biomarkers and Their Determinants in ART-experienced PLWH

NCT05760495

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Mar 8, 2023Actual

Enrollment

543Estimated

Phase

Not provided

Conditions

HIV Infections

Interventions

blood sampling

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2, 2022Actual

Primary Completion Date

May 10, 2023Estimated

Completion Date

May 10, 2023Estimated

First Submitted Date

Feb 2, 2023

First Submission Date that Met QC Criteria

Feb 27, 2023

First Posted Date

Mar 8, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2023

Last Update Posted Date

Mar 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The project aims to assess the level of oxidative stress biomarkers in HIV patients on effective antiretroviral treatment in correlation with other therapeutic, clinical, and viro- immunological parameters. The analysis aims to better characterize the patient on treatment through an innovative approach based on two specific tests for complementary assessment of total oxidant and anti-oxidant plasma capacity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

543Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm		ART-experienced PLWH	Other: blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sampling	Other	Blood sampling for evaluation of oxidative stress markers	Single arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the levels of total oxidant and antioxidant plasma capacity	Quantify the levels of total oxidant and antioxidant plasma capacity antioxidant	1 year

Secondary Outcomes

Measure	Description	Time Frame
Correlation between level of oxidative stress biomarkers and several factors	Evaluation of the impact of therapeutic, viro-immunologic, clinical, and demographic factors on the level of oxidative stress biomarkers.	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ART-treated PLWH
HIV-1 RNA< 50 copies/mL
Stable ART therapy (at least 48 weeks)
Signature of informed consent for study participation

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

aviremic, HIV outpatients on long-term ART

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Francesca Lombardi	Recruiting	Roma	RM	00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided