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

HIV Infections Clinical Trial

— KIRAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158077
• Other study ID #: GeSIDA 8715
• Status: Completed
• Phase: N/A
• First received: May 10, 2017
• Last updated: May 16, 2017
• Start date: November 15, 2016
• Est. completion date: April 20, 2017

Study information

• Verified date: May 2017
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: April 20, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection

Locations

Country	Name	City	State
Spain	Hospital de Alicante	Alicante	Alcante
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	Hospital de Mataró	Mataró	Barcelona
Spain	Complejo hospitalario de Toledo	Toledo
Spain	Hospital Rio Hortega	Valladolid
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness: Proportion of patients with undetectable viral load	Effectiveness in the virological control of RAL and ABC / 3TC	48 weeks
Secondary	Safety-changes in renal function: changes in creatinine values		24 weeks following the change
Secondary	Safety-changes in renal function: changes in glomerular filtration		24 weeks following the change
Secondary	Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL		24 weeks following the change
Secondary	Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL		48 weeks following the change
Secondary	Safety: Changes in serum cholesterol	HDL and LDL cholesterol	24 weeks following the change
Secondary	Safety: Changes in serum triglycerides		24 weeks following the change
Secondary	Safety: Changes in serum cholesterol	HDL and LDL cholesterol	48 weeks following the change
Secondary	Safety: Changes in serum triglycerides		48 weeks following the change
Secondary	Safety: Adverse events.	Frequency of adverse events	24 weeks/48 weeks
Secondary	Safety:serious adverse events	Frequency of serious adverse events	24 weeks/48 weeks
Secondary	Safety: frequency of adverse events leading to discontinuation of treatment.		24 weeks/48 weeks
Secondary	Safety: number of deaths		24 weeks/48 weeks
Secondary	Safety: frequency of laboratory abnormalities.		24 weeks/48 weeks