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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Procedure: Blood sample withdrawal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Naive patients<br>Patients who begin their first antiretroviral regimen. Blood sample withdrawal | Procedure: Blood sample withdrawal<br>* Blood withdrawal for HIV-DNA or HCV resistance test<br>|
| Experienced patients<br>Patients with a history of antiretroviral treatment, switching to a new regimen. Blood sample withdrawal | Procedure: Blood sample withdrawal<br>* Blood withdrawal for HIV-DNA or HCV resistance test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/HCV, Antiretroviral therapy, HIV-DNA, Direct acting antiviral