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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 467

Contacts and Locations

Study Locations

• Spain
  • MAdrid, Spain
    • Hospital 12 de Octubre
  • Madrid, Spain
    • Hospital Ramon y Cajal
  • Madrid, Spain
    • Hospital La Princesa
  • Madrid, Spain
    • Hospital Infanta Leonor
  • Madrid, Spain
    • Hospital Fundacion Jimenez Diaz
  • Madrid, Spain
    • Hospital Univ. La Paz
  • Madrid, Spain
    • Hopital Severo Ochoa
  • Madrid, Spain
    • Hospital Prícipe de Asturias
  • Toledo, Spain
    • Complejo Hospitalario de Toledo
  • Valladolid, Spain
    • Hospital Rio Hortega
  • Zaragoza, Spain
    • Hospital Miguel Servet
  • Alcante
    • Alicante, Alcante, Spain
      • Hospital de Alicante
  • Barcelona
    • Mataró, Barcelona, Spain
      • Hospital de Mataro
  • Murcia
    • Cartagena, Murcia, Spain
      • Hospital Santa Lúcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2016
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): April 20, 2017

Study Registration Dates

• First Submitted: May 10, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: GeSIDA 8715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No