Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks - KIRAL Study
| Registry | NCT03158077, acronym KIRAL |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 467 (Actual) |
| Sponsor | Fundacion SEIMC-GESIDA (Other) |
| Conditions | HIV Infections |
| Dates | start 2016-11-15, primary completion 2017-04-20, completion 2017-04-20, first posted 2017-05-17, last updated 2017-05-17 |
| Locations | 14 sites in Spain |
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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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Raltegravir + ABC/3TC | Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital de Alicante | Alicante, Alcante | Spain | |
| Hospital de Mataró | Mataró, Barcelona | Spain | |
| Hospital Santa Lucia | Cartagena, Murcia | Spain | |
| Hopital Severo Ochoa | Madrid | Spain | |
| Hospital 12 de octubre | Madrid | Spain | |
| Hospital Fundación Jimenez Díaz | Madrid | Spain | |
| Hospital Infanta Leonor | Madrid | Spain | |
| Hospital La Princesa | Madrid | Spain | |
| Hospital Prícipe de Asturias | Madrid | Spain | |
| Hospital Ramón y cajal | Madrid | Spain | |
| Hospital Univ. La Paz | Madrid | Spain | |
| Complejo hospitalario de Toledo | Toledo | Spain | |
| Hospital Rio Hortega | Valladolid | Spain | |
| Hospital Miguel Servet | Zaragoza | Spain |