Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan
- Conditions
- HIV Infections
- Registration Number
- NCT01467349
- Lead Sponsor
- Università Vita-Salute San Raffaele
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-Life 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 Outcome Measures
Name Time Method Real-Life baseline and week 48 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
Trial Locations
- Locations (1)
Infectious Diseases Department
🇮🇹Milan, Italy