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

HIV Clinical Trial

— ViDyMoCo  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02836782
• Other study ID #: Prot.7768/16 ID 1086
• Status: Recruiting
• Start date: April 2016
• Est. completion date: April 2025

Study information

• Verified date: July 2019
• Source: Catholic University of the Sacred Heart
• Contact: Simona Di Giambenedetto, Researcher
• Phone: 0630155366
• Email: simona.digiambenedetto[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: April 2025
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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.

Asselah T, Boyer N, Saadoun D, Martinot-Peignoux M, Marcellin P. Direct-acting antivirals for the treatment of hepatitis C virus infection: optimizing current IFN-free treatment and future perspectives. Liver Int. 2016 Jan;36 Suppl 1:47-57. doi: 10.1111/liv.13027. Review. — View Citation

Bagaglio S, Uberti-Foppa C, Messina E, Merli M, Hasson H, Andolina A, Galli A, Lazzarin A, Morsica G. Distribution of natural resistance to NS3 protease inhibitors in hepatitis C genotype 1a separated into clades 1 and 2 and in genotype 1b of HIV-infected patients. Clin Microbiol Infect. 2016 Apr;22(4):386.e1-386.e3. doi: 10.1016/j.cmi.2015.12.007. Epub 2015 Dec 17. — View Citation

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. — View Citation

Fourati S, Pawlotsky JM. Virologic Tools for HCV Drug Resistance Testing. Viruses. 2015 Dec 4;7(12):6346-59. doi: 10.3390/v7122941. Review. — View Citation

Kostrikis LG, Touloumi G, Karanicolas R, Pantazis N, Anastassopoulou C, Karafoulidou A, Goedert JJ, Hatzakis A; Multicenter Hemophilia Cohort Study Group. Quantitation of human immunodeficiency virus type 1 DNA forms with the second template switch in peripheral blood cells predicts disease progression independently of plasma RNA load. J Virol. 2002 Oct;76(20):10099-108. — View Citation

Perales C, Quer J, Gregori J, Esteban JI, Domingo E. Resistance of Hepatitis C Virus to Inhibitors: Complexity and Clinical Implications. Viruses. 2015 Nov 6;7(11):5746-66. doi: 10.3390/v7112902. Review. — View Citation

Shiramizu B, Paul R, Williams A, Shikuma C, Watters M, Grove J, Valcour V. HIV proviral DNA associated with decreased neuropsychological function. J Neuropsychiatry Clin Neurosci. 2007 Spring;19(2):157-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of HIV/HCV coinfected patients with a significant HIV-DNA decay after 3 years from the enrollment		up to 144 weeks
Secondary	Measurement of HIV-DNA level during HCV antiviral therapy with DAA in HIV/HCV coinfected patients		up to 24 weeks
Secondary	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
Secondary	Comparison of the prevalence of HCV resistance-associated variants in HIV/HCV coinfected population versus HCV monoinfected population		up to 144 weeks