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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02191202
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment
HIV Infections Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Study Type : Observational
Actual Enrollment : 283 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : June 2004
Actual Primary Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. 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 ]
  2. Changes in symptom scale score [ Time Frame: Baseline, month 1, 6 and 12 ]
  3. Changes in Hospital Anxiety and Depression scale (HADS) [ Time Frame: Baseline, month 1, 6 and 12 ]
  4. Changes in cluster of differentiation 4 (CD4) cell count [ Time Frame: Baseline and month 3, 6, 9, 12 ]
  5. Changes in viral load [ Time Frame: Baseline and month 3, 6, 9, 12 ]
  6. Changes in liver function tests [ Time Frame: Baseline and month 3, 6, 9, 12 ]
  7. Changes in total cholesterol [ Time Frame: Baseline, month 6 and 12 ]
  8. Changes in triglycerides [ Time Frame: Baseline, month 6 and 12 ]
  9. Changes in fasting blood glucose [ Time Frame: Baseline, month 6 and 12 ]
  10. Changes in haemoglobin [ Time Frame: Baseline, month 6 and 12 ]
  11. Changes from baseline in plasma urea [ Time Frame: Baseline, month 12 ]
  12. Changes from baseline in creatinine [ Time Frame: Baseline, month 12 ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital physicians, specialized in treatment of patients infected by the HIV

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

Responsible Party: Boehringer Ingelheim Identifier: NCT02191202     History of Changes
Other Study ID Numbers: 1100.1461
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents