HIV InfectionsPhase 4NCT00274001
Quality of Life and Changes in Metabolism of Lipids and Glucose After Switching to a Nevirapine-based Regimen in HIV+ Patients
A Phase 4 study testing Nevirapine in people with HIV Infections and Quality of Life, run by Boehringer Ingelheim at 24 sites in Italy.
Trial summary
The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Quality of Life
- What is being tested?
- Nevirapine
- How many people
- 158 participants
- Where
- 24 sitesItaly
- Study dates
- Sep 2001to Mar 2004
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion criteria:
- Subject suffering with clinically evident fat redistribution including the lipodystrophic syndrome and/or with abnormal values of triglycerides, cholesterol and/or insulin resistance
- Subject on treatment with HAART including PIs for at least 9 months, without therapeutic changes for at least 6 months
- Baseline CD4+ >200 cells/mm3
- HIV-1 RNA levels <200 copies/mL at baseline and during the previous 6 months
Main Exclusion criteria:
- Subject with other serious or chronic disease unrelated to HIV
- Subject with active invasive infections
- Subject with Karnofsky score less than 50
- Prior NNRTs experience
- Documented or suspected acute hepatitis within 30 days prior to baseline visit, irrespective of AST and ALT values that are >5 ULN
- Subject receiving hypolipidemic and/or antidiabetic drugs at study entry
- Subjects with central nervous system disease or pre-existing mental disturbance
- Subjects on methadone chronic treatment at study entry
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Italy24 sites
Ospedale Regionale
Ancona, 60020
Ospedale Santa Maria Annunziata
Antella (fi), 50011
Clinica di Malattie Infettive
Bari, 70124
Ospedali Riuniti di Bergamo
Bergamo, 24128
Ospedale degli Infermi di Biella
Biella, 13900
Istituto di Malattie Infettive
Bologna, 40138
Ospedale Civile
Brescia, 25123
Spedali Civili di Brescia
Brescia, 25123
Ospedale di Circolo di Busto
Busto Arsizio (va), 21052
Ospedale SS. Trinità
Cagliari, 09100
Azienda Ospedaliera Arcispedale S. Anna
Ferrara, 44100
Ospedale San Martino
Genova, 16132
Presidio Ospedaliero "A. Manzoni"
Lecco, 23900
Azienda Ospedaliera Carlo Poma
Mantua, 46100
Ospedale Luigi Sacco
Milan, 20100
Fondazione Centro S. Raffaele del Monte Tabor
Milan, 20127
Azienda Ospedaliera "Luigi Sacco"
Milan, 20157
Ospedale Luigi Sacco
Milan, 20157
Policlinico Universitario
Modena, 41100
Ospedale A. Cotugno
Naples, 80131
Azienda Ospedaliera di Padova
Padova, 35128
IRCCS Policlinico San Matteo
Pavia, 27100
Ospedale Civile
Piacenza, 29100
Ospedale Cisanello
Pisa, 35128
About this study
Official title: An Open, Randomised, Multicentre, Comparative Trial, to Evaluate the Benefit of Switching From a PI-based Regimen to a Nevirapine-based Regimen on the Quality of Life, Patient Adherence, Patient's Perception of Fat Redistribution and Metabolic Changes, in HIV+ Patients Suffering From Fat Abnormalities
The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen.
Read the detailed description
Patients will receive one of the current standard of care regimens for the treatment of HIV infection, i.e. nevirapine (Viramune®) must be administered in conjunction with 2NRTIs, as prescribed by the investigator at the study sites. Patients randomized to the nevirapine (Viramune®)-arm of the study will receive 1x200mg tablet once daily for the first 14 days ("lead in" period) and 1x200 mg tablet twice daily at appropriately spaced intervals subsequently, plus their SOC combination of 2NRTIs as prescribed by the investigators (without changing their prior NRTIs). Patients randomized to continue their standard treatment will receive it as prescribed by the investigators. No dose modification of the study drugs is permitted during the trial. The study drug will be dispensed at randomization and every four weeks thereafter until completion of 48 weeks. After 6 months at least of treatment the switch from PI regimen to NVP regimen will be allowed to all patients included in the PI arm according to patient's willingness. In these patients AST and ALT should be checked at time 0 (switch) and every 2 weeks for 2 months.
Study Hypothesis:
Between treatment comparison of Nevirapine-based regimen versus PI-based regimen will be based on a null hypothesis of no treatment difference. The null hypothesis will be no difference between the two arms at week 24 (month 6th), against the alternative hypothesis that the mean change in physical domain of the QoL will be 10 points score (SD=20) and the difference between triglycerides normalized patients will be 20%.
Comparison(s):
The primary analysis on physical domain of QoL will be performed on the changes between last observation carried forward following the LCOF approach (i.e. visit 6 or in case of premature discontinuation visit 5 or 4) and baseline (visit 2) value using fixed-effects ANCOVA model with center and treatment groups as factors and baseline value and MMA type interaction will be also included in the main model.
- Conditions
- HIV Infections, Quality of Life
- Being tested
- Nevirapine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (WHOQoL questionnaire)
Measured: up to 48 weeks
Change in triglycerides in plasma
Measured: up to 48 weeks
Secondary outcomes (9)
Patients perception of fat redistribution
Measured: up to 48 weeks
Adherence to therapy
Measured: up to 48 weeks
Changes in metabolism of lipids and glucose
Measured: up to 48 weeks
Bone mineral loss
Measured: up to 48 weeks
Therapeutic drug levels of antiretrovirals (drug plasma level / IC90)
Measured: up to 48 weeks
Concentration of antiretrovirals in semen and vaginal secretions
Measured: up to 48 weeks
Viral load
Measured: up to 48 weeks
Immunological status
Measured: up to 48 weeks
Incidence and intensity of clinical and adverse events
Measured: up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startSep 2001
- Primary completionMar 2004
- Study completionMar 2004
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, BI Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274001
- Sponsor's protocol ID
- 1100.1362
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Multicentre, Comparative Trial, to Evaluate the Benefit of Switching From a PI-based Regimen to a Nevirapine-based Regimen on the Quality of Life, Patient Adherence, Patient's Perception of Fat Redistribution and Metabolic Changes, in HIV+ Patients Suffering From Fat Abnormalities
- ClinicalTrials.gov ID
- NCT00274001
- Acronym / sponsor ID
- 1100.1362
- Conditions
- HIV Infections, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 10 Jan 2006 (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.
The purpose of this trial is to compare the effect of switching to nevirapine (Viramune®)-containing regimen on quality of life of patients with fat abnormalities and virological control whilst receiving a PI-based regimen.
Detailed description
Patients will receive one of the current standard of care regimens for the treatment of HIV infection, i.e. nevirapine (Viramune®) must be administered in conjunction with 2NRTIs, as prescribed by the investigator at the study sites. Patients randomized to the nevirapine (Viramune®)-arm of the study will receive 1x200mg tablet once daily for the first 14 days ("lead in" period) and 1x200 mg tablet twice daily at appropriately spaced intervals subsequently, plus their SOC combination of 2NRTIs as prescribed by the investigators (without changing their prior NRTIs). Patients randomized to continue their standard treatment will receive it as prescribed by the investigators. No dose modification of the study drugs is permitted during the trial. The study drug will be dispensed at randomization and every four weeks thereafter until completion of 48 weeks. After 6 months at least of treatment the switch from PI regimen to NVP regimen will be allowed to all patients included in the PI arm according to patient's willingness. In these patients AST and ALT should be checked at time 0 (switch) and every 2 weeks for 2 months.
Study Hypothesis:
Between treatment comparison of Nevirapine-based regimen versus PI-based regimen will be based on a null hypothesis of no treatment difference. The null hypothesis will be no difference between the two arms at week 24 (month 6th), against the alternative hypothesis that the mean change in physical domain of the QoL will be 10 points score (SD=20) and the difference between triglycerides normalized patients will be 20%.
Comparison(s):
The primary analysis on physical domain of QoL will be performed on the changes between last observation carried forward following the LCOF approach (i.e. visit 6 or in case of premature discontinuation visit 5 or 4) and baseline (visit 2) value using fixed-effects ANCOVA model with center and treatment groups as factors and baseline value and MMA type interaction will be also included in the main model.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Nevirapine | Drug | – |
Primary outcome
Quality of Life (WHOQoL questionnaire)
Time frame: up to 48 weeks
Change in triglycerides in plasma
Time frame: up to 48 weeks
9 secondary outcomes
Patients perception of fat redistribution
Time frame: up to 48 weeks
Adherence to therapy
Time frame: up to 48 weeks
Changes in metabolism of lipids and glucose
Time frame: up to 48 weeks
Bone mineral loss
Time frame: up to 48 weeks
Therapeutic drug levels of antiretrovirals (drug plasma level / IC90)
Time frame: up to 48 weeks
Concentration of antiretrovirals in semen and vaginal secretions
Time frame: up to 48 weeks
Viral load
Time frame: up to 48 weeks
Immunological status
Time frame: up to 48 weeks
Incidence and intensity of clinical and adverse events
Time frame: up to 48 weeks
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 1 Nov 2013.
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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.
Boehringer Ingelheim Study Coordinator study chair
BI Italy
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nevirapine in people with HIV Infections and Quality of Life, run by Boehringer Ingelheim at 24 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Life (WHOQoL questionnaire) (time frame: up to 48 weeks). The study lists 2 primary outcomes in all. 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 1 Nov 2013.