Skip to main content
OpenTrials
Completed

NCT Number: NCT03158077

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Alicante, Alicante, Alcante, Spain

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Effectiveness: Proportion of patients with undetectable viral load

    Time frame: 48 weeks

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

Secondary outcomes

  1. Safety-changes in renal function: changes in creatinine values

    Time frame: 24 weeks following the change

  2. Safety-changes in renal function: changes in glomerular filtration

    Time frame: 24 weeks following the change

  3. Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL

    Time frame: 24 weeks following the change

  4. Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL

    Time frame: 48 weeks following the change

  5. Safety: Changes in serum cholesterol

    Time frame: 24 weeks following the change

    HDL and LDL cholesterol

  6. Safety: Changes in serum triglycerides

    Time frame: 24 weeks following the change

  7. Safety: Changes in serum cholesterol

    Time frame: 48 weeks following the change

    HDL and LDL cholesterol

  8. Safety: Changes in serum triglycerides

    Time frame: 48 weeks following the change

  9. Safety: Adverse events.

    Time frame: 24 weeks/48 weeks

    Frequency of adverse events

  10. Safety:serious adverse events

    Time frame: 24 weeks/48 weeks

    Frequency of serious adverse events

  11. Safety: frequency of adverse events leading to discontinuation of treatment.

    Time frame: 24 weeks/48 weeks

  12. Safety: number of deaths

    Time frame: 24 weeks/48 weeks

  13. Safety: frequency of laboratory abnormalities.

    Time frame: 24 weeks/48 weeks

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Registry information

Official study title

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

Acronym: KIRAL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2017
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.