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

Sponsor
Fundacion SEIMC-GESIDA (Other)
Overall Status
Completed
CT.gov ID
NCT03158077
Collaborator
(none)
467
Enrollment
14
Locations
5.1
Actual Duration (Months)
33.4
Patients Per Site
6.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    467 participants
    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
    Actual Study Start Date :
    Nov 15, 2016
    Actual Primary Completion Date :
    Apr 20, 2017
    Actual Study Completion Date :
    Apr 20, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Raltegravir + ABC/3TC

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

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness: Proportion of patients with undetectable viral load [48 weeks]

      Effectiveness in the virological control of RAL and ABC / 3TC

    Secondary Outcome Measures

    1. Safety-changes in renal function: changes in creatinine values [24 weeks following the change]

    2. Safety-changes in renal function: changes in glomerular filtration [24 weeks following the change]

    3. Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL [24 weeks following the change]

    4. Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL [48 weeks following the change]

    5. Safety: Changes in serum cholesterol [24 weeks following the change]

      HDL and LDL cholesterol

    6. Safety: Changes in serum triglycerides [24 weeks following the change]

    7. Safety: Changes in serum cholesterol [48 weeks following the change]

      HDL and LDL cholesterol

    8. Safety: Changes in serum triglycerides [48 weeks following the change]

    9. Safety: Adverse events. [24 weeks/48 weeks]

      Frequency of adverse events

    10. Safety:serious adverse events [24 weeks/48 weeks]

      Frequency of serious adverse events

    11. Safety: frequency of adverse events leading to discontinuation of treatment. [24 weeks/48 weeks]

    12. Safety: number of deaths [24 weeks/48 weeks]

    13. Safety: frequency of laboratory abnormalities. [24 weeks/48 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Alicante Alicante Alcante Spain
    2 Hospital de Mataró Mataró Barcelona Spain
    3 Hospital Santa Lucia Cartagena Murcia Spain
    4 Hopital Severo Ochoa Madrid Spain
    5 Hospital 12 de octubre MAdrid Spain
    6 Hospital Fundación Jimenez Díaz Madrid Spain
    7 Hospital Infanta Leonor Madrid Spain
    8 Hospital La Princesa Madrid Spain
    9 Hospital Prícipe de Asturias Madrid Spain
    10 Hospital Ramón y cajal Madrid Spain
    11 Hospital Univ. La Paz Madrid Spain
    12 Complejo hospitalario de Toledo Toledo Spain
    13 Hospital Rio Hortega Valladolid Spain
    14 Hospital Miguel Servet Zaragoza Spain

    Sponsors and Collaborators

    • Fundacion SEIMC-GESIDA

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundacion SEIMC-GESIDA
    ClinicalTrials.gov Identifier:
    NCT03158077
    Other Study ID Numbers:
    • GeSIDA 8715
    First Posted:
    May 17, 2017
    Last Update Posted:
    May 17, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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:
    Infections
    Communicable Diseases

    Study Results

    No Results Posted as of May 17, 2017