HIV InfectionsNCT01524900

Observational Study of Nevirapine Extended Release in Human Immunodeficiency Virus (HIV) Patients in Daily Clinical Practice

An observational study of HIV Infections, run by Boehringer Ingelheim at 53 sites in 3 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: HIV Infections
How many people: 398 participants
Where: 53 sitesin 3 countries
Study dates: Mar 2012to May 2014
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 to 64 years
All sexes
No healthy volunteers
Adult

Study population: HIV-1 infected patients

Who may be able to join

HIV-1 infected male and female 18 years and above;
anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART.

Who cannot join

Consistent with the current VIRAMUNE prolonged release SPC.

Trial locations and contacts

53 sites in 3 countries.

Country

City, postcode or hospital

53 sites in 3 countries

Romania33 sites

Boehringer Ingelheim Investigational Site 50
Bacau
Boehringer Ingelheim Investigational Site 51
Brasov
Boehringer Ingelheim Investigational Site 52
Brasov
Boehringer Ingelheim Investigational Site 53
Brasov
Boehringer Ingelheim Investigational Site 21
Bucharest
Boehringer Ingelheim Investigational Site 22
Bucharest
Boehringer Ingelheim Investigational Site 23
Bucharest
Boehringer Ingelheim Investigational Site 24
Bucharest
Boehringer Ingelheim Investigational Site 25
Bucharest
Boehringer Ingelheim Investigational Site 26
Bucharest
Boehringer Ingelheim Investigational Site 27
Bucharest
Boehringer Ingelheim Investigational Site 28
Bucharest
Boehringer Ingelheim Investigational Site 29
Bucharest
Boehringer Ingelheim Investigational Site 30
Bucharest
Boehringer Ingelheim Investigational Site 31
Bucharest
Boehringer Ingelheim Investigational Site 32
Bucharest
Boehringer Ingelheim Investigational Site 33
Bucharest
Boehringer Ingelheim Investigational Site 34
Bucharest
Boehringer Ingelheim Investigational Site 35
Bucharest
Boehringer Ingelheim Investigational Site 36
Bucharest
Boehringer Ingelheim Investigational Site 37
Bucharest
Boehringer Ingelheim Investigational Site 38
Bucharest
Boehringer Ingelheim Investigational Site 39
Bucharest
Boehringer Ingelheim Investigational Site 40
Bucharest
Boehringer Ingelheim Investigational Site 41
Bucharest
Boehringer Ingelheim Investigational Site 42
Bucharest
Boehringer Ingelheim Investigational Site 43
Bucharest
Boehringer Ingelheim Investigational Site 44
Bucharest
Boehringer Ingelheim Investigational Site 46
Constanța
Boehringer Ingelheim Investigational Site 47
Constanța
Boehringer Ingelheim Investigational Site 48
Constanța
Boehringer Ingelheim Investigational Site 45
Giurgiu
Boehringer Ingelheim Investigational Site 49
Ploieşti

Other trials in Romania

Poland14 sites

Boehringer Ingelheim Investigational Site 7
Bialystok
Boehringer Ingelheim Investigational Site 8
Bialystok
Boehringer Ingelheim Investigational Site 10
Bydgoszcz
Boehringer Ingelheim Investigational Site 9
Bydgoszcz
Boehringer Ingelheim Investigational Site 11
Chorzów
Boehringer Ingelheim Investigational Site 12
Chorzów
Boehringer Ingelheim Investigational Site 13
Gdañsk
Boehringer Ingelheim Investigational Site 14
Gdañsk
Boehringer Ingelheim Investigational Site 15
Gdañsk
Boehringer Ingelheim Investigational Site 16
Krakow
Boehringer Ingelheim Investigational Site 17
Krakow
Boehringer Ingelheim Investigational Site 18
Poznañ
Boehringer Ingelheim Investigational Site 19
Wroc£aw
Boehringer Ingelheim Investigational Site 20
Wroc£aw

Other trials in Poland

Austria6 sites

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

Other trials in Austria

About this study

Official title: Observational Study Assessing the Safety, Efficacy and Treatment Adherence of Nevirapine Extended Release (Combined With Other Antiretroviral Drugs) in HIV Infected Patients in Daily Clinical Practice

This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and pre-treated patients switching from nevirapine immediate release or other anti-retroviral therapy (ART) will be included in the study. The decision to initiate treatment with nevirapine extended release is independent of this study and is based entirely on individual patient need and the judgement of the treating physician. The aim of the study is to assess the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1 infected patients in routine clinical practice. It is planned to document five visits for each patient over a twenty four week observational period.

Read the detailed description

Study Design:

non-interventional uncontrolled observational study

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 NCT01524900
Study group	Role	What they receive
nevirapine extended release		Not described

What is being measured

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

Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
Measured: up to 72 weeks
Number of Patients Reporting Rash of Any Severity
Number of patients reporting rash of any severity as adverse event
Measured: up to 72 weeks
Number of Patients Reporting Hepatic Events
Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.
Measured: up to 72 weeks

Secondary outcomes (4)

Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of < 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as 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 is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.
Measured: 24 weeks
Change in CD4+ Cell Count From Baseline to Week 24
The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.
Measured: baseline and week 24
Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks
The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
Measured: baseline and week 24
Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation
The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.
Measured: 24 weeks

Timeline

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

Mar 2012May 2014

First posted2 Feb 2012 (estimated)
Study startMar 2012
Primary completionMay 2014
Study completionMay 2014

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
Time perspective: Prospective
Enrolment: 398 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01524900
Sponsor's protocol ID: 1100.1550
Status last verified: Jun 2015
First submitted: 17 Jan 2012
Last updated: 2 Jun 2015
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 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Study Assessing the Safety, Efficacy and Treatment Adherence of Nevirapine Extended Release (Combined With Other Antiretroviral Drugs) in HIV Infected Patients in Daily Clinical Practice
ClinicalTrials.gov ID: NCT01524900
Acronym / sponsor ID: 1100.1550
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 398 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 2 Feb 2012 (estimated)
Results: Posted 2 Jun 2015

Clinical summary

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

Detailed description

Study Design:

non-interventional uncontrolled observational study

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
nevirapine extended release	–	–

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult
Study population: HIV-1 infected patients

Key inclusion criteria (2 listed)

HIV-1 infected male and female 18 years and above;
anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART.

Key exclusion criteria (1 listed)

Consistent with the current VIRAMUNE prolonged release 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

Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
Time frame: up to 72 weeks
The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
Number of Patients Reporting Rash of Any Severity
Time frame: up to 72 weeks
Number of patients reporting rash of any severity as adverse event
Number of Patients Reporting Hepatic Events
Time frame: up to 72 weeks
Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.

4 secondary outcomes

Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
Time frame: 24 weeks
Change in CD4+ Cell Count From Baseline to Week 24
Time frame: baseline and week 24
Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks
Time frame: baseline and week 24
Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation
Time frame: 24 weeks

Results and safety

Results posted to the registry on 2 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment-naive Patients	49	43
Patients Switching From Nevirapine IR	246	232
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	30	29
Pretreated Patients, Baseline Viral Load >50 Copies/mL	22	21
Patients With Baseline Viral Load Not Documented	40	40

Primary outcome: Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation

Time frame: up to 72 weeks. Number. Unit: participants

Measure	Treatment-naive Patients n = 49	Patients Switching From Nevirapine IR n = 246	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL n = 30	Pretreated Patients, Baseline Viral Load >50 Copies/mL n = 22	Patients With Baseline Viral Load Not Documented n = 40
Patients reporting non-serious adverse events	0	4	0	0	0
Patients with serious adverse events	0	2	0	0	0
Patients with nSAEs leading to discontinuation	0	0	0	0	0
Patients with SAEs leading to discontinuation	0	0	0	0	0

Population analysed: Patients from TS.

Primary outcome: Number of Patients Reporting Rash of Any Severity

Time frame: up to 72 weeks. Number. Unit: participants

Measure	Treatment-naive Patients n = 49	Patients Switching From Nevirapine IR n = 246	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL n = 30	Pretreated Patients, Baseline Viral Load>50 Copies/mL n = 22	Patients With Baseline Viral Load Not Documented n = 40
Value	0	0	0	0	0

Population analysed: Patients TS

Primary outcome: Number of Patients Reporting Hepatic Events

Time frame: up to 72 weeks. Number. Unit: participants

Measure	Treatment-naive Patients n = 49	Patients Switching From Nevirapine IR n = 246	Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL n = 30	Pretreated Patients, Baseline Viral Load>50 Copies/mL n = 22	Patients With Baseline Viral Load Not Documented n = 40
Hepatic events reported as AE	0	0	0	0	0
Abnormality in AST	1	3	1	4	1
Abnormality in ALT	11	22	7	9	8
Abnormality in Gamma-GT	11	64	7	5	4
Abnormality in Bilirubin	4	3	0	1	1

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 72 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment-naïve Patients	0 of 49 (0%)	0 of 49 (0%)	Not reported
Patients Switching From Nevirapine IR	2 of 246 (0.8%)	0 of 246 (0%)	Not reported
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML	0 of 30 (0%)	0 of 30 (0%)	Not reported
Pretreated Patients, Baseline Viral Load > 50 Copies/ML	0 of 22 (0%)	0 of 22 (0%)	Not reported
Patients With Baseline Viral Load Not Documented	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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 chair

Boehringer Ingelheim

53 sites in 3 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 53 sites in 3 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 2 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 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Romania, 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 2 Jun 2015). 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?

Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation (time frame: up to 72 weeks). The study lists 3 primary outcomes in all. 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 NCT01524900.

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 2 Jun 2015.