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An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge) (RalAge2)

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ClinicalTrials.gov Identifier: NCT03579485
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriella D'Ettorre, Azienda Policlinico Umberto I

Brief Summary:

This is an observational retrospective cohort in real world to describe RAL data, including NUC-sparing regimens, in aged HIV patients. It is a phase IV study.

90 patients will be enrolled from the Department of Public Health and Infectious Diseases of "Sapienza" University of Rome.

In this retrospective analysis all naïve patients on raltegravir-based regimens and all patients switched to raltegravir-based regimens will be considered.


Condition or disease
Hiv

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Retrospective Database Analysis to Evaluate Raltegravir Based-regimens, Including NUC-sparing Regimens, in Aged HIV Patients.(RalAge)
Actual Study Start Date : January 31, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
aging HIV positive patients
HIV-1 infected patients, aged ≥ 60 years old, naive patients receiving raltegravir based-regimen, including Nuc-sparing regimens or experienced patients with virological suppression (HIV-1 RNA<50 copies) who had switched from any antiretroviral drug to raltegravir-based regimens (including Nuc-sparing regimens) because of toxicity, convenience or other reasons.



Primary Outcome Measures :
  1. HIV-1 viral load [ Time Frame: 12 months ]
    HIV-1 viral load < 50 copies/mL


Secondary Outcome Measures :
  1. CD4+ T-cell counts [ Time Frame: 12 months ]
    Change from Baseline in CD4+ T-cell counts (delta)

  2. CD8 cell counts [ Time Frame: 12 months ]
    Change from Baseline in CD8 cell counts (delta)

  3. CD4/ CD8 ratio [ Time Frame: 12 months ]
    Change from Baseline in CD4/ CD8 ratio (delta)



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A sample size of 90 subjects will be enrolled, they will be produce two-sided 95% CI with the following width: when the sample proportion of patients with an HIV-1 viral load < 50 copies/mL is between 40% and 60%, the 95% CI width is 0.2, that correspond to the possible maximum width in this study. Corresponding widths are 0.17 for a sample proportion of 0.30 (or 0.70), 0.15 for a sample proportion of 0.20 (or 0.80) and 0.13 for a sample proportion of 0.10 (or 0.90) (PASS 11. NCSS, LLC. Kaysville, Utah, USA).
Criteria

Inclusion Criteria:

  • signature of informed consent
  • HIV-1 infected patients,
  • aged ≥ 60 years old
  • naive patients receiving raltegravir based-regimen, including Nuc-sparing regimens,
  • experienced patients with virological suppression (HIV-1 RNA<50 copies) who had switched from any antiretroviral drug to raltegravir-based regimens (including Nuc-sparing regimens) because of toxicity, convenience or other reasons.

Exclusion Criteria:

- pregnancy


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): NCT03579485


Contacts
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Contact: Gabriella d'Ettorre, MD, PhD +390649970801 gabriella.dettorre@uniroma1.it
Contact: vincenzo Vullo, MD +390649970801 vincenzo.vullo@uniroma1.it

Locations
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Italy
Policlinico Umberto I Hospital Recruiting
Rome, Italy, 00155
Contact: Gabriella D'Ettorre       gabriella.dettorre@uniroma1.it   
Principal Investigator: Gabriella D'Ettorre         
Principal Investigator: Vincenzo Vullo         
Sub-Investigator: Giancarlo Ceccarelli         
Sponsors and Collaborators
Azienda Policlinico Umberto I

Publications:
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Responsible Party: Gabriella D'Ettorre, Professor, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT03579485     History of Changes
Other Study ID Numbers: APUmbertoI RalAge2
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Gabriella D'Ettorre, Azienda Policlinico Umberto I:
raltegravir
naive
Aging

Additional relevant MeSH terms:
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Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action