NCT01467349CompletedNot Applicable
Efficacy of Raltegravir in a Large Urban HIV Clinic Population in Milan (Efficacy of Raltegravir in a Large Urban HIV Clinic Setting)
Università Vita-Salute San Raffaele1 site in 1 country400 target enrollmentStarted: December 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Real-Life
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
Primary Outcomes
Real-Life
Time Frame: baseline and week 48
Primary endpoint is the proportion of patients with HIV-1 RNA\<50 copies/ml at weeks 48 after treatment initiation (baseline).
Secondary Outcomes
- Real-Life(baseline and week 48)
Investigators
Elisabetta Carini
Professor Massimo Clementi
Università Vita-Salute San Raffaele
Study Sites (1)
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