Switching Strategy With Raltegravir + ABC / 3TC in Contro... | NCT03158077

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

NCT03158077

Sponsor

Fundacion SEIMC-GESIDA

Status

Completed

Last Update Posted

May 17, 2017Actual

Enrollment

467Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 15, 2016Actual

Primary Completion Date

Apr 20, 2017Actual

Completion Date

Apr 20, 2017Actual

First Submitted Date

May 10, 2017

First Submission Date that Met QC Criteria

May 16, 2017

First Posted Date

May 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2017

Last Update Posted Date

May 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

467Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Raltegravir + ABC/3TC		Switching or switching strategy with RAL and ABC / 3TC guidelines, 48 weeks before the start of the study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effectiveness: Proportion of patients with undetectable viral load	Effectiveness in the virological control of RAL and ABC / 3TC	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV patients that initiated treatment with RAltegravis + ABC/3TC as a switching strategy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Alicante		Alicante	Alcante		Spain
Hospital de Mataró

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided