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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

November 3, 2011
February 8, 2013
December 2011
October 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01467349 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan
Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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.

HIV Infections
Not Provided
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.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01467349
Real-Life Study, n.a., Real-Life
No
Elisabetta Carini, Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
Ospedale San Raffaele
Principal Investigator: Massimo Clementi, Prof. Università Vita-Salute
Università Vita-Salute San Raffaele
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP