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

C

Catholic University of the Sacred Heart

Status

Enrolling

Conditions

HIV

Treatments

Procedure: Blood sample withdrawal

Study type

Observational

Funder types

Other

Identifiers

NCT02836782
Prot.7768/16 ID 1086

Details and patient eligibility

About

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.

Full 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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Simona Di Giambenedetto, Researcher

Data sourced from clinicaltrials.gov

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