Impact of Switching to NNRTI-based Therapy on the Quality... | NCT02191202

Studies
Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression

NCT02191202

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

283Actual

Phase

Not provided

Conditions

HIV Infections

Interventions

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Countries

Not provided

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

Jul 2014

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

Jun 2004

Primary Completion Date

Feb 2006Actual

Completion Date

Not provided

First Submitted Date

Jul 15, 2014

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 16, 2014Estimated

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

Jul 15, 2014

Last Update Posted Date

Jul 16, 2014Estimated

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

283Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)			Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)	Drug		Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score		Baseline, month 1, 6 and 12

Secondary Outcomes

Measure	Description	Time Frame
Comparison of Short version of the Medical Outcomes Study Short-Form General Health Survey-36 (SF12) scores of the study population compared to the general population		Baseline, 12 months
Changes in symptom scale score		Baseline, month 1, 6 and 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NNRTI-naive patients with positive HIV serology, treated with at least triple combination therapy, with a viral load < 500 copies/ml, in whom a new treatment comprising an NNRTI is initiated for a reason other than inefficacy of treatment will be included
Patients must read and write French

Exclusion Criteria:

Patients in whom a new treatment is initiated because of treatment failure
new treatment does not comprise an NNRTI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Hospital physicians, specialized in treatment of patients infected by the HIV

Sampling Method

Non-Probability Sample

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