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Impact of Different Integrase Inhibitor Based Regimen on Immune Activation Among HIV naïve Patient (INTATTI) (INTATTI)

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ClinicalTrials.gov Identifier: NCT03280940
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
EUGENIA QUIROS ROLDAN, Azienda Ospedaliera Spedali Civili di Brescia

Brief Summary:
Low viral replication persistence and immune activation remain important therapeutic challenge in the new HAART era. They are associated with more rapid disease progression, increased risk of mortality and non-AIDS defining events. Soluble biomarkers are a convenient way of assessing immune activation and inflammation in HIV-infected patients receiving effective treatment. There are limited data describing the different effects of currently recommended antiretroviral regimens on immune activation and inflammation during HIV infection. Several studies have shown that raltegravir (the first approved drug from integrase inhibitor class) seems to have more impact on decreasing systemic inflammation compared with other drug classes. Integrase inhibitors may decrease inflammation and immune activation more than other antiretroviral drugs, because they are more lipid friendly and may concentrate better in enterocytes. The aim of this observational study is to compare the impact of different integrase inhibitor based regimen on changes in markers of inflammation (Il-2, IL-6, sTNFR-1, sCD14, sCD163, sICAM, hsRCP , sVCAM, LPS, D-dimer) during the first year of effective first-line combination. This is a 48-week observational retrospective study, to compare the change in infiammatory markers between naïve patients who start INI based regimen. Participants will be recruited from the HIV outpatient clinic. The study compare the impact of commonly used first-line antiretroviral drugs on soluble markers of inflammation and immune activation. The study is conducted on treatment-naive HIV-infected patients who experience a rapid and persistent virological response and that do not switch their initial regimen for at least 1 years. The analyses will be adjusted for baseline characteristics that might influence the choice of cART regimen or affect biomarker levels, such as age, smoking status, CD4 cell count, plasma HIV-1 viral load. Investigators enroll patients with a rapid and persistent virological response and that do not experience any blips. Cryopreserved plasma sample are obtained at baseline and at month 6 and 12 after treatment starting. Two NRTI backbone combinations (TDF/FTC vs ABC/3TC) and three third agents (RAL vs ELV vs DTG) will be compared in a factorial design. The results will be expressed as the estimated percentage difference between the mean fold changes observed with a given drug, using TDF/FTC and RAL as the reference groups for the comparison.

Condition or disease
HIV Infections

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of Different Integrase Inhibitor Based Regimen on Markers of Inflammation and Immune Activation Among HIV naïve Patient During the First Year of Effective First-line Combination
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
Dolutegravir treatment group
Naïve patients having documented HIV-1 infection and starting their first antiretroviral treatment with a dolutegravir containing regimen
Raltegravir treatment group
Naïve patients having documented HIV-1 infection and starting their first antiretroviral treatment with a raltegravir containing regimen
Elvitegravir treatment group
Naïve patients having documented HIV-1 infection and starting their first antiretroviral treatment with a elvitegravir containing regimen
Protease inhibitors treatment group
Naïve patients having documented HIV-1 infection and starting their first antiretroviral treatment with a protease inhibitors containing regimen



Primary Outcome Measures :
  1. Inflammation outcomes 48 week [ Time Frame: 48 week ]
    Evaluate the changes from baseline to week 48 in level of markers of inflammation (IL-2, IL-6, sTNFR-1, sCD14, sCD163, sICAM, hsRCP , sVCAM, LPS, D-dimer) in patients who receive first line antiretroviral therapy


Secondary Outcome Measures :
  1. Inflammation outcomes 24 week [ Time Frame: 24 week ]
    Evaluate the changes from baseline to week 24 in level of markers of inflammation (IL-2, IL-6, sTNFR-1, sCD14, sCD163, sICAM, hsRCP , sVCAM, LPS, D-dimer) in patients who receive first line antiretroviral therapy


Biospecimen Retention:   Samples Without DNA
Serum (Biospecimen retained as a normal clinical practice)


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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:   Non-Probability Sample
Study Population
Treatment-naive HIV-infected patients followed at University Division of Infectious and Tropical Diseases, University of Brescia (Italy) who experience a rapid and persistent virological response and remain on their initial regimen for 1 years
Criteria

Inclusion Criteria:

  • Naïve patients having documented HIV-1 infection, of age 18 years and older

Exclusion Criteria:

  1. Patients with diagnosed CVD, diabetes, uncontrolled hypertension (screening systolic blood pressure >160 mm Hg or diastolic pressure >90 mm Hg),
  2. Other systemic inflammatory disease (hepatitis B or C coinfection was allowed)
  3. Estimated creatinine clearance <70 mL/min;
  4. HIV-1 RNA level of <1000 copies/mL,
  5. Prior ART use
  6. Estimated glomerular filtration rate (eGFR) of <70 mL/min by the Cockcroft-Gault equation
  7. Liver transaminase levels <5 times the upper limit of normal
  8. Absolute neutrophil count of <1000 neutrophils/mm3
  9. Platelet count of ≥50 000 platelets/mm3
  10. Hemoglobin level of ≥8.5 g/dL
  11. Use of lipid-lowering drugs
  12. Life expectancy of ≥1 year from the time of enrollment
  13. AIDS-defining conditions diagnosed within 30 days
  14. Active infection or malignancy
  15. Current alcohol or substance use judged to potentially interfere with study compliance

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): NCT03280940


Locations
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Italy
AO Spedali Civili di Brescia
Brescia, BS, Italy, 25123
Sponsors and Collaborators
Azienda Ospedaliera Spedali Civili di Brescia
Investigators
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Principal Investigator: Eugenia Quiros Roldan, Prof AO Spedali Civili di Brescia

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Responsible Party: EUGENIA QUIROS ROLDAN, Prof., Azienda Ospedaliera Spedali Civili di Brescia
ClinicalTrials.gov Identifier: NCT03280940     History of Changes
Other Study ID Numbers: INTATTI
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by EUGENIA QUIROS ROLDAN, Azienda Ospedaliera Spedali Civili di Brescia:
Inflammation
Immune activation
Integrase Inhibitors
Naive patients

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Protease Inhibitors
Dolutegravir
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
HIV Integrase Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents