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

NCT03579485 | Unknown DMC

• 1 other identifier: APUmbertoI RalAge2
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hiv

Keywords

raltegravir; naive; Aging

Outcome Measures

Primary Outcomes (1)

• HIV-1 viral load

  HIV-1 viral load \< 50 copies/mL

  12 months

Secondary Outcomes (3)

• CD4+ T-cell counts

  12 months

• CD8 cell counts

  12 months

• CD4/ CD8 ratio

  12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• \- pregnancy

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead

Study Sites (1)

Policlinico Umberto I Hospital

Rome, 00155, Italy

RECRUITING

Related Publications (2)

• Pavone P, Giustini N, Fimiani C, Paoletti F, Falciano M, Salotti A, Di Sora F, Al Moghazi S, Mezzaroma I, Vullo V, d'Ettorre G. Long-Term Treatment With Raltegravir is Associated with Lower Triglycerides and Platelets Count in the Older HIV+ Population: Results from the Ral-Age Study. Curr HIV Res. 2017 Nov 23;15(5):355-360. doi: 10.2174/1570162X15666170927124558.

  PMID: 28969567 BACKGROUND

• Santinelli L, Ceccarelli G, Borrazzo C, Celani L, Pavone P, Innocenti GP, Spagnolello O, Fimiani C, Ceci F, Di Sora F, Mezzaroma I, Mastroianni CM, d'Ettorre G. Real word outcomes associated with use of raltegravir in older people living with HIV: results from the 60 months follow-up of the RAL-age cohort. Expert Rev Anti Infect Ther. 2020 May;18(5):485-492. doi: 10.1080/14787210.2020.1733415. Epub 2020 Feb 25.

  PMID: 32096433 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Gabriella d'Ettorre, MD, PhD

CONTACT

+390649970801; gabriella.dettorre@uniroma1.it

vincenzo Vullo, MD

CONTACT

+390649970801; vincenzo.vullo@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 6, 2018
• Study Start: January 31, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IT (1)