Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection

Study Overview
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Brief Summary
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Retrospective observational study, multicentric with Spanish hospitals, in which a switching or change strategy with RAL and ABC / 3TC guidelines was used, in the48 weeks before the start of the study, in order to determine parameters of Effectiveness and security.

Detailed Description
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The study consists of a 4-weeks data recording period, during which the follow-up information recorded by physicians in electronic or paper medical history will be analyzed from patients who opted for a change to that study pattern (RAL and ABC / 3TC).

Official Title
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Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks - KIRAL Study

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with chronic infection with HIV-1. Patients older than 18 years. Patients in ART in whom RAL + ABC / 3TC has been initiated in at least 48 Weeks prior to the start of the study. To have used the RAL + ABC / 3TC as a switching or change strategy HIV virological control (CV ≤ 50 copies / ml) for at least 24 weeks prior to initiation of study regimen Exclusion Criteria: NAIVE patients who have started treatment with this regimen Absence of digital or physical records of visits made for consultation Patients who underwent treatment change within 48 weeks prior to study initiation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Raltegravir + ABC/3TC<br>Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Proportion of patients with undetectable viral load | Effectiveness in the virological control of RAL and ABC / 3TC | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety-changes in renal function: changes in creatinine values |  | 24 weeks following the change | 
| Safety-changes in renal function: changes in glomerular filtration |  | 24 weeks following the change | 
| Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL |  | 24 weeks following the change | 
| Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL |  | 48 weeks following the change | 
| Safety: Changes in serum cholesterol | HDL and LDL cholesterol | 24 weeks following the change | 
| Safety: Changes in serum triglycerides |  | 24 weeks following the change | 
| Safety: Changes in serum cholesterol | HDL and LDL cholesterol | 48 weeks following the change | 
| Safety: Changes in serum triglycerides |  | 48 weeks following the change | 
| Safety: Adverse events. | Frequency of adverse events | 24 weeks/48 weeks | 
| Safety:serious adverse events | Frequency of serious adverse events | 24 weeks/48 weeks | 
| Safety: frequency of adverse events leading to discontinuation of treatment. |  | 24 weeks/48 weeks | 
| Safety: number of deaths |  | 24 weeks/48 weeks | 
| Safety: frequency of laboratory abnormalities. |  | 24 weeks/48 weeks |