NCT05760495

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
543

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

March 8, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

February 2, 2023

Last Update Submit

February 27, 2023

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Correlation between level of oxidative stress biomarkers and several factors

    1 year

Study Arms (1)

Single arm

ART-experienced PLWH

Other: blood sampling

Interventions

blood samplingOTHER

Blood sampling for evaluation of oxidative stress markers

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

aviremic, HIV outpatients on long-term ART

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francesca Lombardi

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

March 8, 2023

Study Start

September 2, 2022

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

March 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)