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

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ClinicalTrials.gov Identifier: NCT02836782
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Simona Di Giambenedetto, Catholic University of the Sacred Heart

Study Description
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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.

Condition or disease Intervention/treatment
HIV Procedure: Blood sample withdrawal

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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 Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Group/Cohort Intervention/treatment
Naive patients
Patients who begin their first antiretroviral regimen. Blood sample withdrawal
 Procedure: Blood sample withdrawal
Blood withdrawal for HIV-DNA or HCV resistance test
Experienced patients

Patients with a history of antiretroviral treatment, switching to a new regimen.

Blood sample withdrawal

 Procedure: Blood sample withdrawal
Blood withdrawal for HIV-DNA or HCV resistance test


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start [ Time Frame: up to 144 weeks ]

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

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected patients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836782


Contacts
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Contact: Simona Di Giambenedetto, Researcher 0630155366 simona.digiambenedetto@unicatt.it

Locations
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Italy
Catholic University of Sacred Heart Recruiting
Rome, Italy, 00168
Contact: Simona Di Giambenedetto, Researcher    00390630155366    simona.digiambenedetto@unicatt.it   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Principal Investigator: Simona Di Giambenedetto, Researcher Catholic University of Sacred Heart
More Information
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Additional Information:

Publications:
Di Maio VC, Cento V, Di Paolo D, Aragri M, De Leonardis F, Tontodonati M, Micheli V, Bellocchi MC, Antonucci FP, Bertoli A, Lenci I, Milana M, Gianserra L, Melis M, Di Biagio A, Sarrecchia C, Sarmati L, Landonio S, Francioso S, Lambiase L, Nicolini LA, Marenco S, Nosotti L, Giannelli V, Siciliano M, Romagnoli D, Pellicelli A, Vecchiet J, Magni CF, Babudieri S, Mura MS, Taliani G, Mastroianni C, Vespasiani-Gentilucci U, Romano M, Morisco F, Gasbarrini A, Vullo V, Bruno S, Baiguera C, Pasquazzi C, Tisone G, Picciotto A, Andreoni M, Parruti G, Rizzardini G, Angelico M, Perno CF, Ceccherini-Silberstein F; HCV Italian Resistance Network Study Group. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels. J Antimicrob Chemother. 2016 Mar;71(3):739-50. doi: 10.1093/jac/dkv403. Epub 2015 Dec 17.
AASLD/IDSA/IAS-USA RETREATMENT OF PERSONS IN WHOM PRIOR THERAPY HAS FAILED. Recommendations for testing, managing, and treating hepatitis C. date accessed 5.01. 2015.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Simona Di Giambenedetto, Researcher, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02836782    
Other Study ID Numbers: Prot.7768/16 ID 1086
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Simona Di Giambenedetto, Catholic University of the Sacred Heart:
HIV/HCV
Antiretroviral therapy
HIV-DNA
Direct acting antiviral