HIV InfectionsKIRALNCT03158077
Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection
An observational study of HIV Infections, run by Fundacion SEIMC-GESIDA at 14 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 467 participants
- Where
- 14 sitesSpain
- Study dates
- 15 Nov 2016to 20 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV patients that initiated treatment with RAltegravis + ABC/3TC as a switching strategy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Spain14 sites
Hospital de Alicante
Alicante, Alcante
Hospital Santa Lucia
Cartagena, Murcia
Hopital Severo Ochoa
Madrid
Hospital 12 de octubre
Madrid
Hospital Fundación Jimenez Díaz
Madrid
Hospital Infanta Leonor
Madrid
Hospital La Princesa
Madrid
Hospital Prícipe de Asturias
Madrid
Hospital Ramón y cajal
Madrid
Hospital Univ. La Paz
Madrid
Hospital de Mataró
Mataró, Barcelona
Complejo hospitalario de Toledo
Toledo
Hospital Rio Hortega
Valladolid
Hospital Miguel Servet
Zaragoza
About this study
Official title: Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks - KIRAL Study
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.
Read the 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).
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir + ABC/3TC | Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Proportion of patients with undetectable viral load
Effectiveness in the virological control of RAL and ABC / 3TC
Measured: 48 weeks
Secondary outcomes (13)
Safety-changes in renal function: changes in creatinine values
Measured: 24 weeks following the change
Safety-changes in renal function: changes in glomerular filtration
Measured: 24 weeks following the change
Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL
Measured: 24 weeks following the change
Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL
Measured: 48 weeks following the change
Safety: Changes in serum cholesterol
HDL and LDL cholesterol
Measured: 24 weeks following the change
Safety: Changes in serum triglycerides
Measured: 24 weeks following the change
Safety: Changes in serum cholesterol
HDL and LDL cholesterol
Measured: 48 weeks following the change
Safety: Changes in serum triglycerides
Measured: 48 weeks following the change
Safety: Adverse events.
Frequency of adverse events
Measured: 24 weeks/48 weeks
Safety:serious adverse events
Frequency of serious adverse events
Measured: 24 weeks/48 weeks
Safety: frequency of adverse events leading to discontinuation of treatment.
Measured: 24 weeks/48 weeks
Safety: number of deaths
Measured: 24 weeks/48 weeks
Safety: frequency of laboratory abnormalities.
Measured: 24 weeks/48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 Nov 2016
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158077
- Sponsor's protocol ID
- GeSIDA 8715
- Acronym
- KIRAL
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching Strategy With Raltegravir + ABC / 3TC in Controlled HIV-1 Infection: Observational Retrospective Study at 48 Weeks - KIRAL Study
- ClinicalTrials.gov ID
- NCT03158077
- Acronym / sponsor ID
- KIRAL / GeSIDA 8715
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Raltegravir + ABC/3TC | – | –Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV patients that initiated treatment with RAltegravis + ABC/3TC as a switching strategy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness: Proportion of patients with undetectable viral load
Time frame: 48 weeks
Effectiveness in the virological control of RAL and ABC / 3TC
13 secondary outcomes
Safety-changes in renal function: changes in creatinine values
Time frame: 24 weeks following the change
Safety-changes in renal function: changes in glomerular filtration
Time frame: 24 weeks following the change
Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL
Time frame: 24 weeks following the change
Safety: Changes in serum levels of AST, ALT, FA, GGT and BIL
Time frame: 48 weeks following the change
Safety: Changes in serum cholesterol
Time frame: 24 weeks following the change
Safety: Changes in serum triglycerides
Time frame: 24 weeks following the change
Safety: Changes in serum cholesterol
Time frame: 48 weeks following the change
Safety: Changes in serum triglycerides
Time frame: 48 weeks following the change
Safety: Adverse events.
Time frame: 24 weeks/48 weeks
Safety:serious adverse events
Time frame: 24 weeks/48 weeks
Safety: frequency of adverse events leading to discontinuation of treatment.
Time frame: 24 weeks/48 weeks
Safety: number of deaths
Time frame: 24 weeks/48 weeks
Safety: frequency of laboratory abnormalities.
Time frame: 24 weeks/48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Fundacion SEIMC-GESIDA at 14 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Proportion of patients with undetectable viral load (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.