HIV InfectionsNCT02191202
Impact of Switching to NNRTI-based Therapy on the Quality of Life of HIV-infected Patients With Virological Suppression
An observational study of HIV Infections, run by Boehringer Ingelheim.
Trial summary
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
- How many people
- 283 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Feb 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospital physicians, specialized in treatment of patients infected by the HIV
Who may be able to join
- 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
Who cannot join
- Patients in whom a new treatment is initiated because of treatment failure
- new treatment does not comprise an NNRTI
About this study
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
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients
- Conditions
- HIV Infections
- Being tested
- Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)Drug
| Study group | Role | What they receive |
|---|---|---|
| Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) | Not described Receives: Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score
Measured: Baseline, month 1, 6 and 12
Secondary outcomes (12)
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
Measured: Baseline, 12 months
Changes in symptom scale score
Measured: Baseline, month 1, 6 and 12
Changes in Hospital Anxiety and Depression scale (HADS)
Measured: Baseline, month 1, 6 and 12
Changes in cluster of differentiation 4 (CD4) cell count
Measured: Baseline and month 3, 6, 9, 12
Changes in viral load
Measured: Baseline and month 3, 6, 9, 12
Changes in liver function tests
Measured: Baseline and month 3, 6, 9, 12
Changes in total cholesterol
Measured: Baseline, month 6 and 12
Changes in triglycerides
Measured: Baseline, month 6 and 12
Changes in fasting blood glucose
Measured: Baseline, month 6 and 12
Changes in haemoglobin
Measured: Baseline, month 6 and 12
Changes from baseline in plasma urea
Measured: Baseline, month 12
Changes from baseline in creatinine
Measured: Baseline, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJun 2004
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191202
- Sponsor's protocol ID
- 1100.1461
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02191202
- Acronym / sponsor ID
- 1100.1461
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Feb 2006 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study to evaluate therapeutic switch to a NNRTI-based regimen on quality of life of HIV-positive patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) | – | Drug: Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospital physicians, specialized in treatment of patients infected by the HIV
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Patients in whom a new treatment is initiated because of treatment failure
- new treatment does not comprise an NNRTI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) | Drug | Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) |
Primary outcome
Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score
Time frame: Baseline, month 1, 6 and 12
12 secondary outcomes
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
Changes in symptom scale score
Time frame: Baseline, month 1, 6 and 12
Changes in Hospital Anxiety and Depression scale (HADS)
Time frame: Baseline, month 1, 6 and 12
Changes in cluster of differentiation 4 (CD4) cell count
Time frame: Baseline and month 3, 6, 9, 12
Changes in viral load
Time frame: Baseline and month 3, 6, 9, 12
Changes in liver function tests
Time frame: Baseline and month 3, 6, 9, 12
Changes in total cholesterol
Time frame: Baseline, month 6 and 12
Changes in triglycerides
Time frame: Baseline, month 6 and 12
Changes in fasting blood glucose
Time frame: Baseline, month 6 and 12
Changes in haemoglobin
Time frame: Baseline, month 6 and 12
Changes from baseline in plasma urea
Time frame: Baseline, month 12
Changes from baseline in creatinine
Time frame: Baseline, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in World Health Organization Quality of Life - HIV (WHOQOL-HIV) score (time frame: Baseline, month 1, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.