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

NCT ID: NCT03158077

Last Updated: 2017-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-15

Study Completion Date

2017-04-20

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).

Conditions

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HIV Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Raltegravir + ABC/3TC

Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion SEIMC-GESIDA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de Alicante

Alicante, Alcante, Spain

Site Status

Hospital de Mataró

Mataró, Barcelona, Spain

Site Status

Hospital Santa Lucia

Cartagena, Murcia, Spain

Site Status

Hopital Severo Ochoa

Madrid, , Spain

Site Status

Hospital 12 de octubre

Madrid, , Spain

Site Status

Hospital Fundación Jimenez Díaz

Madrid, , Spain

Site Status

Hospital Infanta Leonor

Madrid, , Spain

Site Status

Hospital La Princesa

Madrid, , Spain

Site Status

Hospital Prícipe de Asturias

Madrid, , Spain

Site Status

Hospital Ramón y cajal

Madrid, , Spain

Site Status

Hospital Univ. La Paz

Madrid, , Spain

Site Status

Complejo hospitalario de Toledo

Toledo, , Spain

Site Status

Hospital Rio Hortega

Valladolid, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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GeSIDA 8715

Identifier Type: -

Identifier Source: org_study_id

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