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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT02191202
First received: July 15, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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


Condition Intervention
HIV Infections
Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score [ Time Frame: Baseline, month 1, 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes in symptom scale score [ Time Frame: Baseline, month 1, 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in Hospital Anxiety and Depression scale (HADS) [ Time Frame: Baseline, month 1, 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in cluster of differentiation 4 (CD4) cell count [ Time Frame: Baseline and month 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Changes in viral load [ Time Frame: Baseline and month 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Changes in liver function tests [ Time Frame: Baseline and month 3, 6, 9, 12 ] [ Designated as safety issue: No ]
  • Changes in total cholesterol [ Time Frame: Baseline, month 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in triglycerides [ Time Frame: Baseline, month 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in fasting blood glucose [ Time Frame: Baseline, month 6 and 12 ] [ Designated as safety issue: No ]
  • Changes in haemoglobin [ Time Frame: Baseline, month 6 and 12 ] [ Designated as safety issue: No ]
  • Changes from baseline in plasma urea [ Time Frame: Baseline, month 12 ] [ Designated as safety issue: No ]
  • Changes from baseline in creatinine [ Time Frame: Baseline, month 12 ] [ Designated as safety issue: No ]

Enrollment: 283
Study Start Date: June 2004
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02191202     History of Changes
Other Study ID Numbers: 1100.1461
Study First Received: July 15, 2014
Last Updated: July 15, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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

ClinicalTrials.gov processed this record on November 19, 2014