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

July 15, 2014 updated by: Boehringer Ingelheim

Observational Study of the Impact on Quality-of-life of a Switch From a Virologically Effective Regimen to a Regimen Containing a Non-Nucleoside Reverse Transcriptase Inhibitor (QUALVI) Nevirapine (Viramune®) Clinical Phase IV

Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Baseline, 12 months
Baseline, 12 months
Changes in symptom scale score
Time Frame: Baseline, month 1, 6 and 12
Baseline, month 1, 6 and 12
Changes in Hospital Anxiety and Depression scale (HADS)
Time Frame: Baseline, month 1, 6 and 12
Baseline, month 1, 6 and 12
Changes in cluster of differentiation 4 (CD4) cell count
Time Frame: Baseline and month 3, 6, 9, 12
Baseline and month 3, 6, 9, 12
Changes in viral load
Time Frame: Baseline and month 3, 6, 9, 12
Baseline and month 3, 6, 9, 12
Changes in liver function tests
Time Frame: Baseline and month 3, 6, 9, 12
Baseline and month 3, 6, 9, 12
Changes in total cholesterol
Time Frame: Baseline, month 6 and 12
Baseline, month 6 and 12
Changes in triglycerides
Time Frame: Baseline, month 6 and 12
Baseline, month 6 and 12
Changes in fasting blood glucose
Time Frame: Baseline, month 6 and 12
Baseline, month 6 and 12
Changes in haemoglobin
Time Frame: Baseline, month 6 and 12
Baseline, month 6 and 12
Changes from baseline in plasma urea
Time Frame: Baseline, month 12
Baseline, month 12
Changes from baseline in creatinine
Time Frame: Baseline, month 12
Baseline, month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 15, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 15, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100.1461

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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