NCT02836782

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

4 years

First QC Date

May 5, 2016

Last Update Submit

July 23, 2019

Conditions

HIV

Keywords

HIV/HCVAntiretroviral therapyHIV-DNADirect acting antiviral

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

    up to 144 weeks

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

    up to 24 weeks

  • 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

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

    up to 144 weeks

Study Arms (2)

Naive patients

Patients who begin their first antiretroviral regimen. Blood sample withdrawal

Procedure: Blood sample withdrawal

Experienced patients

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

Procedure: Blood sample withdrawal

Interventions

Blood sample withdrawalPROCEDURE

Blood withdrawal for HIV-DNA or HCV resistance test

Experienced patientsNaive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HIV-infected patients

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Sacred Heart

Rome, 00168, Italy

RECRUITING

Related Publications (9)

  • 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.

    PMID: 12239284BACKGROUND

  • 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.

    PMID: 17431062BACKGROUND

  • 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.

    PMID: 26725897BACKGROUND

  • 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.

    PMID: 26706617BACKGROUND

  • 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.

    PMID: 26679249BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 26690198BACKGROUND

  • 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.

    PMID: 26561827BACKGROUND

  • 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.

    PMID: 32101614DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Officials

  • Simona Di Giambenedetto, Researcher

    Catholic University of Sacred Heart

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Di Giambenedetto, Researcher

CONTACT

0630155366simona.digiambenedetto@unicatt.it

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 5, 2016

First Posted

July 19, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2025

Last Updated

July 24, 2019

Record last verified: 2019-07

Locations

IT(1)