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


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This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Fundacion SEIMC-GESIDA

ClinicalTrials.gov Identifier:

NCT03158077

First received: May 10, 2017

Last updated: May 16, 2017

Last verified: May 2017

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.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks – KIRAL Study

Primary Outcome Measures:

Secondary Outcome Measures:

Enrollment: 467
Actual Study Start Date: November 15, 2016
Study Completion Date: April 20, 2017
Primary Completion Date: April 20, 2017 (Final data collection date for primary outcome measure)
Raltegravir + ABC/3TC

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

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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

HIV patients that initiated treatment with RAltegravis + ABC/3TC as a switching strategy

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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03158077

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

Fundacion SEIMC-GESIDA

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT03158077     History of Changes
Other Study ID Numbers: GeSIDA 8715
Study First Received: May 10, 2017
Last Updated: May 16, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection
Communicable Diseases
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 May 17, 2017