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Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan (Real-Life)
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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) |
- 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).
- Real-Life [ Time Frame: 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
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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:
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01467349
| Italy | |
| Infectious Diseases Department | |
| Milan, Italy, 20127 | |
| 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. ( Other Grant/Funding Number: Merck Sharp & Dohme ) Real-Life ( Other Grant/Funding Number: Merck Sharp & Dohme ) |
| Study First Received: | November 3, 2011 |
| Last Updated: | February 8, 2013 |
Keywords provided by Elisabetta Carini, Università Vita-Salute San Raffaele:
|
Raltegravir efficacy safety raltegravir-containing regimens HIV urban clinic setting |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 27, 2017