Efficacy of Raltegravir in a Large Urban HIV Clinical Population in Milan (Real-Life)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01467349 |
|
Recruitment Status
:
Completed
First Posted
: November 8, 2011
Last Update Posted
: February 11, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease |
|---|
| HIV Infections |
| Study Type : | Observational |
| Actual Enrollment : | 400 participants |
| 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) |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | October 2012 |
| Actual Study Completion Date : | December 2012 |
| Group/Cohort |
|---|
|
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. |
- 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
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, Learn About Clinical Studies.
| 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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467349
| Italy | |
| Infectious Diseases Department | |
| Milan, Italy, 20127 | |
| Principal Investigator: | Massimo Clementi, Prof. | Università Vita-Salute |
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 ) |
| First Posted: | November 8, 2011 Key Record Dates |
| Last Update Posted: | February 11, 2013 |
| Last Verified: | February 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 |