HIV-DNA Dynamics in HIV Monoinfected or HIV/HCV Coinfected Patients

Recruiting

• Conditions: HIV
• Interventions: Procedure: Blood sample withdrawal

• Registration Number: NCT02836782
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

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.

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-05
• Study First Submitted QC: 2016-07-14
• Study First Posted: 2016-07-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24
• Primary Completion: 2020-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Naive patients	Blood sample withdrawal	Patients who begin their first antiretroviral regimen. Blood sample withdrawal
Experienced patients	Blood sample withdrawal	Patients with a history of antiretroviral treatment, switching to a new regimen. Blood sample withdrawal

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Catholic University of Sacred Heart; 🇮🇹 Rome, Italy