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CompletedNCT02191202Updated Jul 16, 2014

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

An observational study in HIV Infections, sponsored by Boehringer Ingelheim. Completed. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
283
Sex
All
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Study summary

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

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Conditions studied

  • HIV Infections

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03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 283 is above the median of 200 across 713 observational studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
283 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

    Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)

Interventions

  • DrugNon-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
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What researchers measure

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02191202
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 16, 2014
Start date
Jun 2004
Primary completion
Feb 2006
Last update
Jul 16, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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