Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan (Real-Life)

This study has been completed.
Sponsor:
Collaborator:
Ospedale San Raffaele
Information provided by (Responsible Party):
Elisabetta Carini, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01467349
First received: November 3, 2011
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

This will be a retrospective analysis of efficacy, safety and tolerability of raltegravir as part of an optimized therapy in a clinical setting.

Follow-up is calculated from the treatment initiation (with or without raltegravir) up to the date of discontinuation of the considered regimen or the date of last visit or the date of lost to follow-up, whichever came first.

The Aim of the study is to evaluate the efficacy and safety of raltegravir-containing regimens in a urban clinic setting.


Condition
HIV Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)

Resource links provided by NLM:


Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Real-Life [ Time Frame: baseline and week 48 ] [ Designated as safety issue: No ]
    Primary endpoint is the proportion of patients with HIV-1 RNA<50 copies/ml at weeks 48 after treatment initiation (baseline).


Secondary Outcome Measures:
  • Real-Life [ Time Frame: baseline and week 48 ] [ Designated as safety issue: No ]

    Secondary endpoints are:

    • Proportion of patients with HIV-1 RNA<50 copies/ml at the end of the treatment/last available visit
    • Proportion of patients with HIV-1 RNA<400 copies/ml at week 48
    • Increase in absolute CD4 cell count from baseline
    • Frequency of side effects associated with raltegravir treatment
    • Frequency of reasons for starting/stopping raltegravir treatment


Enrollment: 400
Study Start Date: December 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Raltegravir group

This study will include subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

A control group will be used for the evaluation of the primary and secondary objectives in comparison to patients treated with raltegravir (study patients). The control group will be constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV co-infection status yes/no). For control patients, the last antiretroviral regimen prescribed will be considered.


  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study will include subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

A control group will be used for the evaluation of the primary and secondary objectives in comparison to patients treated with raltegravir (study patients). The control group will be constituted by subjects who never received raltegravir, matched (in a ratio 1:3) with the study subjects by gender, age (± 3 years), CD4+ cells counts (± 50 cells) and HCV co-infection status yes/no). For control patients, the last antiretroviral regimen prescribed will be considered.

Criteria

Inclusion Criteria:

  • Subjects who received raltegravir and were previously exposed to NRTIs, NNRTIs, PIs, regardless of the stage of HIV disease at the start of the treatment.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467349

Locations
Italy
Infectious Diseases Department
Milan, Italy, 20127
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Ospedale San Raffaele
Investigators
Principal Investigator: Massimo Clementi, Prof. Università Vita-Salute
  More Information

Publications:
Responsible Party: Elisabetta Carini, Professor Massimo Clementi, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01467349     History of Changes
Other Study ID Numbers: Real-Life Study, n.a., Real-Life
Study First Received: November 3, 2011
Last Updated: February 8, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Università Vita-Salute San Raffaele:
Raltegravir
efficacy
safety
raltegravir-containing regimens
HIV urban clinic setting

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014