Clinical trial NCT02836782: HIV-DNA Dynamics in HIV Monoinfected or HIV/HCV Coinfected Patients
Official title: Dynamics of Viral Reservoir in HIV-positive Patients With or Without HCV Coinfection in the Era of Direct-acting Antiviral and Antiretroviral Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Keywords: HIV/HCV
Antiretroviral therapy
HIV-DNA
Direct acting antiviral
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start
timeFrame: up to 144 weeks
Secondary outcomes:
measure: Percentage of HIV/HCV coinfected patients with a significant HIV-DNA decay after 3 years from the enrollment
timeFrame: up to 144 weeks
measure: Measurement of HIV-DNA level during HCV antiviral therapy with DAA in HIV/HCV coinfected patients
timeFrame: up to 24 weeks
measure: Prevalence of HCV resistance-associated variants and their relation with HIV-DNA levels in HIV/HCV coinfected patients, treated or not treated for HCV.
timeFrame: up to 144 weeks
measure: Comparison of the prevalence of HCV resistance-associated variants in HIV/HCV coinfected population versus HCV monoinfected population
timeFrame: up to 144 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
affiliation: Catholic University of Sacred Heart
name: Simona Di Giambenedetto, Researcher
role: PRINCIPAL_INVESTIGATOR
References:
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