Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection
KIRAL
1 other identifier
observational
467
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Shorter than P25 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedMay 17, 2017
May 1, 2017
5 months
May 10, 2017
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness: Proportion of patients with undetectable viral load
Effectiveness in the virological control of RAL and ABC / 3TC
48 weeks
Secondary Outcomes (13)
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
24 weeks following the change
- +8 more secondary outcomes
Study Arms (1)
Raltegravir + ABC/3TC
Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study
Eligibility Criteria
HIV patients that initiated treatment with RAltegravis + ABC/3TC as a switching strategy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 17, 2017
Study Start
November 15, 2016
Primary Completion
April 20, 2017
Study Completion
April 20, 2017
Last Updated
May 17, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share