TrialReader


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

NCT03158077 — Completed, 467 participants, Fundacion SEIMC-GESIDA

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT03158077, acronym KIRAL
StatusCompleted
Study typeObservational
Enrollment467 (Actual)
SponsorFundacion SEIMC-GESIDA (Other)
ConditionsHIV Infections
Datesstart 2016-11-15, primary completion 2017-04-20, completion 2017-04-20, first posted 2017-05-17, last updated 2017-05-17
Locations14 sites in Spain

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for HIV Infections

-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.

Expand all sections  ·  Collapse all

+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).

+Arms and interventions

ArmTypeInterventionsDescription
Raltegravir + ABC/3TCSwitching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study

+Outcome measures

Primary outcomes

  • Effectiveness: Proportion of patients with undetectable viral load [48 weeks]: Effectiveness in the virological control of RAL and ABC / 3TC

Secondary outcomes

  • 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]: HDL and LDL cholesterol
  • Safety: Changes in serum triglycerides [24 weeks following the change]
  • Safety: Changes in serum cholesterol [48 weeks following the change]: HDL and LDL cholesterol
  • Safety: Changes in serum triglycerides [48 weeks following the change]
  • Safety: Adverse events. [24 weeks/48 weeks]: Frequency of adverse events
  • Safety:serious adverse events [24 weeks/48 weeks]: Frequency of serious adverse events
  • 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]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (14)

FacilityCityCountryStatus
Hospital de AlicanteAlicante, AlcanteSpain
Hospital de MataróMataró, BarcelonaSpain
Hospital Santa LuciaCartagena, MurciaSpain
Hopital Severo OchoaMadridSpain
Hospital 12 de octubreMadridSpain
Hospital Fundación Jimenez DíazMadridSpain
Hospital Infanta LeonorMadridSpain
Hospital La PrincesaMadridSpain
Hospital Prícipe de AsturiasMadridSpain
Hospital Ramón y cajalMadridSpain
Hospital Univ. La PazMadridSpain
Complejo hospitalario de ToledoToledoSpain
Hospital Rio HortegaValladolidSpain
Hospital Miguel ServetZaragozaSpain

My Notes