HIV
Conditions
Keywords
HIV/HCV, Antiretroviral therapy, HIV-DNA, Direct acting antiviral
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.
Interventions
PROCEDUREBlood sample withdrawal
Blood withdrawal for HIV-DNA or HCV resistance test
Sponsors
Catholic University of the Sacred Heart
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Italy
Contacts
Primary ContactSimona Di Giambenedetto, Researcher
Outcome results
None listed