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HIVViDyMoCoNCT02836782

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

An observational study of HIV, run by Catholic University of the Sacred Heart at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Blood sample withdrawal
Type of treatment
Surgery or procedure
How many people
600 participants
Where
1 siteItaly
Study dates
Apr 2016to Apr 2025
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: HIV-infected patients

Who may be able to join

  • 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.

Who cannot join

  • Patient's deny
  • Clinical contraindications to blood sample withdrawal

Trial locations and contacts

1 site in 1 country.

Simona Di Giambenedetto, Researcher contact

0630155366

simona.digiambenedetto@unicatt.it

Italy1 site, 1 recruiting

  • Catholic University of Sacred Heart

    Rome, 00168

    Simona Di Giambenedetto, Researcher, 00390630155366, simona.digiambenedetto@unicatt.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
HIV
Being tested
Blood sample withdrawal
Keywords
HIV/HCV, Antiretroviral therapy, HIV-DNA, Direct acting antiviral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sample withdrawalProcedure or surgery

    Blood withdrawal for HIV-DNA or HCV resistance test

Study groups in NCT02836782
Study groupRoleWhat they receive
Naive patientsPatients who begin their first antiretroviral regimen. Blood sample withdrawal
Receives: Procedure: Blood sample withdrawal
Experienced patientsPatients with a history of antiretroviral treatment, switching to a new regimen. Blood sample withdrawal
Receives: Procedure: Blood sample withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of HIV-positive patients with a significant HIV-DNA decay after 3 years from a new antiretroviral regimen start

    Measured: up to 144 weeks

Secondary outcomes (4)

  1. Percentage of HIV/HCV coinfected patients with a significant HIV-DNA decay after 3 years from the enrollment

    Measured: up to 144 weeks

  2. Measurement of HIV-DNA level during HCV antiviral therapy with DAA in HIV/HCV coinfected patients

    Measured: 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.

    Measured: up to 144 weeks

  4. Comparison of the prevalence of HCV resistance-associated variants in HIV/HCV coinfected population versus HCV monoinfected population

    Measured: up to 144 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2020 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
600 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02836782
Sponsor's protocol ID
Prot.7768/16 ID 1086
Acronym
ViDyMoCo
Status last verified
Jul 2019
First submitted
5 May 2016
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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. doi: 10.1128/jvi.76.20.10099-10108.2002.

    PubMed 12239284

  • 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. doi: 10.1176/jnp.2007.19.2.157.

    PubMed 17431062

  • 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.

    PubMed 26725897

  • 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.

    PubMed 26706617

  • 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.

    PubMed 26679249

  • 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.

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

    PubMed 26690198

  • 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.

    PubMed 26561827

  • Lombardi F, Belmonti S, Borghetti A, Fabbiani M, Marchetti S, Tamburrini E, Cauda R, di Giambenedetto S. Evolution of cellular HIV DNA levels in virologically suppressed patients switching to dolutegravir/lamivudine versus maintaining a triple regimen: a prospective, longitudinal, matched, controlled study. J Antimicrob Chemother. 2020 Jun 1;75(6):1599-1603. doi: 10.1093/jac/dkaa058.

    PubMed 32101614

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by Catholic University of the Sacred Heart at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Simona Di Giambenedetto, Researcher (0630155366, simona.digiambenedetto@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02836782, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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