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Completed

NCT Number: NCT02191202

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

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Drug

Primary outcomes

  1. Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score

    Time frame: Baseline, month 1, 6 and 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
First posted
Jul 16, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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