PMS Assessing the Long-term Efficacy and Safety of Nevirapine Therapy (Combined With Other ARV Drugs) in HIV-1 Positive Patients in Daily Clinical Practice.

An observational study of HIV Infections, run by Boehringer Ingelheim at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
How many people: 280 participants
Where: 17 sitesin 2 countries
Study dates: Sep 2008to Jul 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Study population: patients

Who may be able to join

The inclusion criteria follow the same criteria which are describe in the newest SPC.

Who cannot join

The exclusion criteria follow the same criteria which are describe in the newest SPC.

Trial locations and contacts

17 sites in 2 countries.

Country

City, postcode or hospital

17 sites in 2 countries

Poland10 sites

Boehringer Ingelheim Investigational Site 8
Bialystok
Boehringer Ingelheim Investigational Site 9
Bydgoszcz
Boehringer Ingelheim Investigational Site 10
Chorzów
Boehringer Ingelheim Investigational Site 11
Gdansk
Boehringer Ingelheim Investigational Site 12
Krakow
Boehringer Ingelheim Investigational Site 13
Lódz
Boehringer Ingelheim Investigational Site 14
Poznan
Boehringer Ingelheim Investigational Site 15
Szczecin
Boehringer Ingelheim Investigational Site 16
Warsaw
Boehringer Ingelheim Investigational Site 17
Wroclaw

Other trials in Poland

Austria7 sites

Boehringer Ingelheim Investigational Site 1
Graz
Boehringer Ingelheim Investigational Site 2
Linz
Boehringer Ingelheim Investigational Site 3
Salzburg
Boehringer Ingelheim Investigational Site 4
Vienna
Boehringer Ingelheim Investigational Site 5
Vienna
Boehringer Ingelheim Investigational Site 6
Vienna
Boehringer Ingelheim Investigational Site 7
Wels

Other trials in Austria

About this study

Official title: Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients in the Daily Clinical Practice.

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.

Conditions: HIV Infections
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00736502
Study group	Role	What they receive
Patients HIV-1 positive		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients Reporting Adverse Events
the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.
Measured: 48 weeks

Secondary outcomes (2)

Virologic Response (VR)
VR was defined as Human immunodeficiency virus (HIV) viral load of <50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by two consecutive measurements of Viral load (VL) >= 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL < 50 copies/mL. A change of ARV therapy was defined as a permanent discontinuation of Nevirapine.
Measured: 48 weeks
Change in CD4+ Cell Count From Baseline to Week 48
Calculated as CD4+ cell count at week 48 minus the baseline value
Measured: Baseline and week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Jul 2011

First posted18 Aug 2008 (estimated)
Study startSep 2008
Primary completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 280 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00736502
Sponsor's protocol ID: 1100.1527
Status last verified: Feb 2014
First submitted: 7 Jul 2008
Last updated: 7 Mar 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Longterm Efficacy and Safety of NVP-based HAART in HIV-1 Positive Patients in the Daily Clinical Practice.
ClinicalTrials.gov ID: NCT00736502
Acronym / sponsor ID: 1100.1527
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 280 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Jul 2011 (actual)
First posted: 18 Aug 2008 (estimated)
Results: Posted 31 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients HIV-1 positive	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients

Key inclusion criteria (1 listed)

The inclusion criteria follow the same criteria which are describe in the newest SPC.

Key exclusion criteria (1 listed)

The exclusion criteria follow the same criteria which are describe in the newest SPC.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Proportion of Patients Reporting Adverse Events
Time frame: 48 weeks
the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.

2 secondary outcomes

Virologic Response (VR)
Time frame: 48 weeks
Change in CD4+ Cell Count From Baseline to Week 48
Time frame: Baseline and week 48

Results and safety

Results posted to the registry on 31 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nevirapine	278	213

Primary outcome: Proportion of Patients Reporting Adverse Events

Time frame: 48 weeks. Number. Unit: Percentage of participants

Measure	Nevirapine n = 278
any event	25.5
serious adverse events	4.3
adverse events leading to discontinuation	9.7
rash, any severity	3.2
hepatic events, any severity	3.2
Central Nervous system side effects, any severity	3.6

Population analysed: The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nevirapine	12 of 278 (4.3%)	0 of 278 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

Not yet recruiting
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HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
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HIV, Substance Use Disorder

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 chair

Boehringer Ingelheim

17 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections, run by Boehringer Ingelheim at 17 sites in 2 countries.

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 1 inclusion and 1 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 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Poland, Austria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Patients Reporting Adverse Events (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00736502.

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 7 Mar 2014.