HIV InfectionsNCT00876733
Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
An observational study of HIV Infections, run by Boehringer Ingelheim at 66 sites in Germany.
Trial summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 605 participants
- Where
- 66 sitesGermany
- Study dates
- Mar 2009to Dec 2013
- 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
- male and female
- 18 years or older
- written informed consent
- The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC
Who cannot join
- Pregnant patients
- The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC
Trial locations and contacts
66 sites in 1 country.
66 sites in 1 country
Germany66 sites
Boehringer Ingelheim Investigational Site 14
Aachen
Boehringer Ingelheim Investigational Site 12
Berlin
Boehringer Ingelheim Investigational Site 13
Berlin
Boehringer Ingelheim Investigational Site 15
Berlin
Boehringer Ingelheim Investigational Site 19
Berlin
Boehringer Ingelheim Investigational Site 21
Berlin
Boehringer Ingelheim Investigational Site 23
Berlin
Boehringer Ingelheim Investigational Site 24
Berlin
Boehringer Ingelheim Investigational Site 28
Berlin
Boehringer Ingelheim Investigational Site 30
Berlin
Boehringer Ingelheim Investigational Site 31
Berlin
Boehringer Ingelheim Investigational Site 34
Berlin
Boehringer Ingelheim Investigational Site 38
Berlin
Boehringer Ingelheim Investigational Site 41
Berlin
Boehringer Ingelheim Investigational Site 54
Berlin
Boehringer Ingelheim Investigational Site 60
Berlin
Boehringer Ingelheim Investigational Site 63
Berlin
Boehringer Ingelheim Investigational Site 8
Berlin
Boehringer Ingelheim Investigational Site 58
Bochum
Boehringer Ingelheim Investigational Site 50
Chemnitz
Boehringer Ingelheim Investigational Site 53
Cologne
Boehringer Ingelheim Investigational Site 61
Cologne
Boehringer Ingelheim Investigational Site 48
Dortmund
Boehringer Ingelheim Investigational Site 27
Duisburg
Boehringer Ingelheim Investigational Site 49
Düsseldorf
Boehringer Ingelheim Investigational Site 62
Düsseldorf
Boehringer Ingelheim Investigational Site 9
Düsseldorf
Boehringer Ingelheim Investigational Site 32
Frankfurt
Boehringer Ingelheim Investigational Site 59
Frankfurt
Boehringer Ingelheim Investigational Site 65
Frankfurt
Boehringer Ingelheim Investigational Site 57
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 56
Fürth
Boehringer Ingelheim Investigational Site 29
Giessen
Boehringer Ingelheim Investigational Site 33
Hamburg
Boehringer Ingelheim Investigational Site 42
Hamburg
Boehringer Ingelheim Investigational Site 47
Hamburg
Boehringer Ingelheim Investigational Site 51
Hamburg
Boehringer Ingelheim Investigational Site 40
Hanover
Boehringer Ingelheim Investigational Site 43
Hanover
Boehringer Ingelheim Investigational Site 46
Hanover
Boehringer Ingelheim Investigational Site 6
Karlsruhe
Boehringer Ingelheim Investigational Site 25
Koblenz
Boehringer Ingelheim Investigational Site 37
Krefeld
Boehringer Ingelheim Investigational Site 11
Leipzig
Boehringer Ingelheim Investigational Site 52
Mainz
Boehringer Ingelheim Investigational Site 18
München
Boehringer Ingelheim Investigational Site 20
München
Boehringer Ingelheim Investigational Site 22
München
Boehringer Ingelheim Investigational Site 26
München
Boehringer Ingelheim Investigational Site 35
München
Boehringer Ingelheim Investigational Site 5
München
Boehringer Ingelheim Investigational Site 16
Münster
Boehringer Ingelheim Investigational Site 17
Münster
Boehringer Ingelheim Investigational Site 39
Münster
Boehringer Ingelheim Investigational Site 55
Münster
Boehringer Ingelheim Investigational Site 10
Neuss
Boehringer Ingelheim Investigational Site 36
Oldenburg
Boehringer Ingelheim Investigational Site 64
Osnabrück
Boehringer Ingelheim Investigational Site 7
Pforzheim
Boehringer Ingelheim Investigational Site 66
Potsdam
Boehringer Ingelheim Investigational Site 1
Stuttgart
Boehringer Ingelheim Investigational Site 3
Stuttgart
Boehringer Ingelheim Investigational Site 4
Stuttgart
Boehringer Ingelheim Investigational Site 45
Troisdorf
Boehringer Ingelheim Investigational Site 2
Wiesbaden
Boehringer Ingelheim Investigational Site 44
Wuppertal
About this study
Official title: Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
- 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 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.
Number of Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
Measured: 36 months
Secondary outcomes (24)
Changes in the Viral Load After 12 Months From Baseline.
The change in the log10 viral load from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a negative change represents a decrease in viral load.
Measured: Baseline and 12 months
Changes in the Viral Load After 36 Months From Baseline.
The change in the log10 viral load from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a negative change represents a decrease in viral load.
Measured: Baseline and 36 months
Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
The change in the CD4+ cell count from baseline after 12 months was calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase in CD4+ cell count.
Measured: Baseline and 12 months
Changes in the CD4+ Cell Count After 36 Months From Baseline.
The change in the CD4+ cell count from baseline after 36 months was calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase in CD4+ cell count.
Measured: Baseline and 36 months
Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
The changes in the laboratory data (Total Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
The changes in the laboratory data (Triglycerides) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
The changes in the laboratory data (Blood Glucose) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (ALT) After 12 Months From Baseline
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (AST) After 12 Months From Baseline
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
The changes in the laboratory data (Creatinine) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
The changes in the laboratory data (Haemoglobin) from baseline after 12 months were calculated by subtracting the baseline value from the value after 12 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 12 months
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
The changes in the laboratory data (Total Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
The changes in the laboratory data ( High density protein (HDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
The changes in the laboratory data ( Low density protein (LDL) Cholesterol) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
The changes in the laboratory data (Triglycerides) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
The changes in the laboratory data (Blood Glucose) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (ALT) After 36 Months From Baseline
The changes in the laboratory data (Alanine transaminase (ALT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (AST) After 36 Months From Baseline
The changes in the laboratory data (Aspartate transminase (AST)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
The changes in the laboratory data (Gamma glutamyl transferase (Gamma GT)) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
The changes in the laboratory data (Creatinine) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
The changes in the laboratory data (Haemoglobin) from baseline after 36 months were calculated by subtracting the baseline value from the value after 36 months. Therefore, a positive change represents an increase, a negative change represents a decrease in the data.
Measured: Baseline and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
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
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876733
- Sponsor's protocol ID
- 1100.1524
- Status last verified
- Jan 2015
- First submitted
- 20 Mar 2009
- Last updated
- 16 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Observational Study With Viramune Plus ARV in HIV Infected Patients
- ClinicalTrials.gov ID
- NCT00876733
- Acronym / sponsor ID
- 1100.1524
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Apr 2009 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and ARV, e.g. Combivir (Zidovudine and Lamivudine), Kivexa (Abacavir and Lamivudine) or Truvada (tenofovir and emtricitabine).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
Key inclusion criteria (4 listed)
- male and female
- 18 years or older
- written informed consent
- The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals / SmPC
Key exclusion criteria (2 listed)
- Pregnant patients
- The exclusion criteria for the treatment of Viramune plus other antiretroviral combination drugs are to be based on the current SmPC
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 Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs
Time frame: 36 months
Number of participants with Treatment Emergent Adverse Events (AE) and All Serious AEs
24 secondary outcomes
Changes in the Viral Load After 12 Months From Baseline.
Time frame: Baseline and 12 months
Changes in the Viral Load After 36 Months From Baseline.
Time frame: Baseline and 36 months
Changes in the Cluster of Differentiation 4 (CD4+) Cell Count After 12 Months From Baseline.
Time frame: Baseline and 12 months
Changes in the CD4+ Cell Count After 36 Months From Baseline.
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Total Cholesterol) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (HDL Cholesterol) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (LDL Cholesterol) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Triglycerides) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Blood Glucose) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (ALT) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (AST) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Gamma GT) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Creatinine) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Haemoglobin) After 12 Months From Baseline
Time frame: Baseline and 12 months
Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (ALT) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (AST) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Gamma GT) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline
Time frame: Baseline and 36 months
Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline
Time frame: Baseline and 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 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
66 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 66 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?
The sponsor lists 4 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 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 Jan 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 Participants With Treatment Emergent Adverse Events (AE) and All Serious AEs (time frame: 36 months). 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 Jan 2015.