HIV-DNA Dynamics in HIV Monoinfected or HIV/HCV Coinfected Patients (ViDyMoCo)

July 23, 2019 updated by: Simona Di Giambenedetto, Catholic University of the Sacred Heart

Dynamics of Viral Reservoir in HIV-positive Patients With or Without HCV Coinfection in the Era of Direct-acting Antiviral and Antiretroviral Drugs

New markers of viral activity are now under investigation. Aim of the study is to investigate the efficacy of new antiretroviral drugs by monitoring HIV-DNA dynamics in HIV-positive population. In HIV/HCV coinfected population, the study of HIV reservoir dynamics and the analysis of the prevalence of HCV resistance-associated mutations will help clinicians to improve the management of coinfected patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

New markers of viral activity are now under investigation. Besides HIV-RNA and CD4 cells count, HIV-DNA is an emerging marker of viral reservoir, that seems to be associated with the risk of HIV-related diseases, especially in HCV coinfected patients. New antiretroviral drugs, particularly integrase inhibitors, are expected to decrease residual viremia and, consequently, viral reservoir. Monitoring of HIV-DNA dynamics during antiretroviral treatment could lead to a better management of HIV infected population.

Also, the role of HCV in influencing HIV natural history requires careful monitoring. In particular, with a broader use of direct acting antiretroviral, the analysis of prevalence of HCV resistance associated mutation will be more and more important to manage patients with treatment failure.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV-infected patients

Description

Inclusion Criteria:

  • Persons ≥ 18 years-old;
  • Signing an informed consent to study participation and data treatment;
  • HIV-positive patients, beginning a new antiretroviral treatment patients or with clinically relevant events;
  • HCV-positive patients beginning an antiviral treatment with DAA.

Exclusion Criteria:

  • Patient's deny
  • Clinical contraindications to blood sample withdrawal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Naive patients
Patients who begin their first antiretroviral regimen. Blood sample withdrawal
Procedure: Blood sample withdrawal
Blood withdrawal for HIV-DNA or HCV resistance test
Experienced patients

Patients with a history of antiretroviral treatment, switching to a new regimen.

Blood sample withdrawal
Procedure: Blood sample withdrawal
Blood withdrawal for HIV-DNA or HCV resistance test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start
Time Frame: up to 144 weeks
up to 144 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of HIV/HCV coinfected patients with a significant HIV-DNA decay after 3 years from the enrollment
Time Frame: up to 144 weeks
up to 144 weeks
Measurement of HIV-DNA level during HCV antiviral therapy with DAA in HIV/HCV coinfected patients
Time Frame: up to 24 weeks
up to 24 weeks
Prevalence of HCV resistance-associated variants and their relation with HIV-DNA levels in HIV/HCV coinfected patients, treated or not treated for HCV.
Time Frame: up to 144 weeks
up to 144 weeks
Comparison of the prevalence of HCV resistance-associated variants in HIV/HCV coinfected population versus HCV monoinfected population
Time Frame: up to 144 weeks
up to 144 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Principal Investigator: Simona Di Giambenedetto, Researcher, Catholic University Of Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 19, 2016

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Prot.7768/16 ID 1086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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