HIV InfectionsNCT00979420

Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune

An observational study of HIV Infections, run by Boehringer Ingelheim at 60 sites in Germany.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
How many people: Not given
Where: 60 sitesGermany
Study dates: Aug 2009to Nov 2010
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

Inclusion criteria The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843)

Exclusion criteria The exclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC (R08-0843).

Trial locations and contacts

60 sites in 1 country.

City, postcode or hospital

60 sites in 1 country

Germany60 sites

Boehringer Ingelheim Investigational Site 1
Aachen
Boehringer Ingelheim Investigational Site 10
Berlin
Boehringer Ingelheim Investigational Site 11
Berlin
Boehringer Ingelheim Investigational Site 12
Berlin
Boehringer Ingelheim Investigational Site 13
Berlin
Boehringer Ingelheim Investigational Site 14
Berlin
Boehringer Ingelheim Investigational Site 15
Berlin
Boehringer Ingelheim Investigational Site 2
Berlin
Boehringer Ingelheim Investigational Site 3
Berlin
Boehringer Ingelheim Investigational Site 4
Berlin
Boehringer Ingelheim Investigational Site 5
Berlin
Boehringer Ingelheim Investigational Site 6
Berlin
Boehringer Ingelheim Investigational Site 7
Berlin
Boehringer Ingelheim Investigational Site 8
Berlin
Boehringer Ingelheim Investigational Site 9
Berlin
Boehringer Ingelheim Investigational Site 16
Bochum
Boehringer Ingelheim Investigational Site 17
Bonn
Boehringer Ingelheim Investigational Site 18
Bremen
Boehringer Ingelheim Investigational Site 19
Dortmund
Boehringer Ingelheim Investigational Site 20
Duisburg
Boehringer Ingelheim Investigational Site 21
Düsseldorf
Boehringer Ingelheim Investigational Site 22
Düsseldorf
Boehringer Ingelheim Investigational Site 23
Düsseldorf
Boehringer Ingelheim Investigational Site 24
Düsseldorf
Boehringer Ingelheim Investigational Site 25
Frankfurt
Boehringer Ingelheim Investigational Site 26
Frankfurt
Boehringer Ingelheim Investigational Site 27
Frankfurt
Boehringer Ingelheim Investigational Site 28
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 29
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 30
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 31
Hamburg
Boehringer Ingelheim Investigational Site 32
Hamburg
Boehringer Ingelheim Investigational Site 33
Hamburg
Boehringer Ingelheim Investigational Site 34
Hamburg
Boehringer Ingelheim Investigational Site 35
Hamburg
Boehringer Ingelheim Investigational Site 36
Hamburg
Boehringer Ingelheim Investigational Site 37
Hanover
Boehringer Ingelheim Investigational Site 38
Hanover
Boehringer Ingelheim Investigational Site 39
Hanover
Boehringer Ingelheim Investigational Site 40
Heidelberg
Boehringer Ingelheim Investigational Site 41
Karlsruhe
Boehringer Ingelheim Investigational Site 42
Koblenz
Boehringer Ingelheim Investigational Site 43
Leipzig
Boehringer Ingelheim Investigational Site 44
Mannheim
Boehringer Ingelheim Investigational Site 45
Mannheim
Boehringer Ingelheim Investigational Site 46
München
Boehringer Ingelheim Investigational Site 47
München
Boehringer Ingelheim Investigational Site 48
München
Boehringer Ingelheim Investigational Site 49
München
Boehringer Ingelheim Investigational Site 50
München
Boehringer Ingelheim Investigational Site 51
Münster
Boehringer Ingelheim Investigational Site 52
Münster
Boehringer Ingelheim Investigational Site 53
Münster
Boehringer Ingelheim Investigational Site 54
Oldenburg
Boehringer Ingelheim Investigational Site 55
Osnabrück
Boehringer Ingelheim Investigational Site 56
Saarbrücken
Boehringer Ingelheim Investigational Site 57
Stuttgart
Boehringer Ingelheim Investigational Site 58
Stuttgart
Boehringer Ingelheim Investigational Site 59
Stuttgart
Boehringer Ingelheim Investigational Site 60
Wuppertal

Other trials in Germany

About this study

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). An observation period of about 10 years extends far beyond the duration of clinical trials. First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.

Read the detailed description

Study Design:

observational

Conditions: HIV Infections
Keywords: treatment experienced
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 NCT00979420
Study group	Role	What they receive
HIV treatment		Not described

What is being measured

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

Change in log10 Viral Load From Baseline to Last Visit
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.
Measured: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Measured: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Measured: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Measured: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.

Secondary outcomes (12)

Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
Duration of intake of Viramune ranges from 14 to 185 months. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events ("DAIDS AE Grading Table") was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
Duration of intake of Viramune ranges from 14 to 185 months. The "DAIDS AE Grading Table" was used for grading the safety laboratory parameters. Grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = potentially life-threatening.
Measured: Up to 185 months
Duration of Intake of Viramune
Duration of intake of Viramune
Measured: End of treatment, up to 185 months
History of Therapy With Antiretroviral Medication
Participants with a history of therapy with antiretroviral medication.
Measured: Baseline
Course of Absolute CD4+ Cell Count
The course of absolute CD4+ cell count is presented as the absolute CD4+ cell count at last visit.
Measured: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
Number of Participants With Drug Related Adverse Events
Number of participants with drug related Adverse Events (AEs)
Measured: Up to 185 months

Timeline

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

Aug 2009Nov 2010

First posted18 Sep 2009 (estimated)
Study startAug 2009
Primary completionNov 2010

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: Retrospective

IDs, dates and publications

ClinicalTrials.gov ID: NCT00979420
Sponsor's protocol ID: 1100.1535
Status last verified: Jun 2014
First submitted: 16 Sep 2009
Last updated: 30 Jun 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?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune
ClinicalTrials.gov ID: NCT00979420
Acronym / sponsor ID: 1100.1535
Conditions: HIV Infections
Keywords: treatment experienced
Study type: Observational
Recruitment status: Completed
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Nov 2010 (actual)
First posted: 18 Sep 2009 (estimated)
Results: Posted 16 Aug 2012

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:

observational

Study design

Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
HIV treatment	–	–

Who may qualify

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

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

Change in log10 Viral Load From Baseline to Last Visit
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available visit viral load minus the baseline viral load.
Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit
Time frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.
Change in Absolute CD4 Lymphocytes (CD4+ Cells) From Baseline to Last Visit
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.
Baseline is defined as the last documentation before start of therapy with Viramune. The change from baseline reflects the last available number of CD4+ cells minus the baseline number of CD4+ cells.

12 secondary outcomes

Number of Patients With Laboratory Abnormalities for Cholesterol During Study (Worst Grade) by Division of AIDS (DAIDS) Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Low-density Lipoprotein (LDL) Cholesterol During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Triglycerides During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Blood Glucose During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Alanine Aminotransferase (ALT) During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Aspartate Aminotransferase (AST) During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Creatinine During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Number of Patients With Laboratory Abnormalities for Hemoglobin During Study (Worst Grade) by DAIDS Grade
Time frame: Up to 185 months
Duration of Intake of Viramune
Time frame: End of treatment, up to 185 months
History of Therapy With Antiretroviral Medication
Time frame: Baseline
Course of Absolute CD4+ Cell Count
Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months
Number of Participants With Drug Related Adverse Events
Time frame: Up to 185 months

Results and safety

Results posted to the registry on 16 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
Treatment-naive Patients	178	171
Pre-treated Patients With Baseline HIV RNA <50 Copies/ml	57	57
Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml	60	59
Pre-treated Patients With Baseline HIV RNA Not Documented	61	59

Primary outcome: Change in log10 Viral Load From Baseline to Last Visit

Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.. Median (Full Range). Unit: log10 copies/ml

Measure	Treatment-naive Patients n = 86	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml n = 57	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n = 60
Value	-3.260 (-5.61;2.25)	-0.099 (-1.69;0.70)	-2.082 (-5.82;0.40)

Population analysed: Full analysis set (FAS): This patient set includes all patients from Treated Set (TS) who have documented at least one value for the viral load before start of therapy with Viramune.

Primary outcome: Number of Participants With Viral Load <50 Copies/ml and >=50 Copies/ml at Last Visit

Time frame: Last available visit. Duration of intake of Viramune ranges from 14 to 185 months.. Number. Unit: Participants

Measure	Treatment-naive Patients n = 86	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml n = 57	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n = 60
<50 copies/ml	83	55	55
>=50 copies/ml	3	2	5
Missing	0	0	0

Population analysed: FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Primary outcome: Change in Absolute CD4 Lymphocytes (CD4+) Cells From Baseline to Last Visit

Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.. Median (Full Range). Unit: CD4+ cells/mm3

Measure	Treatment-naive Patients n = 83	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml n = 56	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n = 60
Value	380 (-323;1749)	223.5 (-328;1104)	228 (-360;1004)

Population analysed: FAS: This patient set includes all patients from TS who have documented at least one value for the viral load before start of therapy with Viramune.

Primary outcome: Change in log10 Viral Load From Baseline to Last Visit

Time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.. Median (Full Range). Unit: log10 copies/ml

Measure	Treatment-naive Patients n = 63	Pre-treated Patients With Baseline HIV RNA<50 Copies/ml n = 34	Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml n = 33
Value	-3.284 (-5.61;0.00)	0.000 (-0.41;0.70)	-2.000 (-5.824;0.40)

Population analysed: Per protocol set (PPS): All patients from FAS without treatment interruptions and who are treated with Viramune for at least 10 years.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 14 to 185 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Viramune	35 of 356 (9.8%)	60 of 356 (16.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

60 sites in 1 country: 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 60 sites in Germany.

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 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Germany. 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 16 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?

Change in log10 Viral Load From Baseline to Last Visit (time frame: Baseline and last available visit. Duration of intake of Viramune ranges from 14 to 185 months.). The study lists 4 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 NCT00979420.

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 30 Jun 2014.