HIV InfectionsNCT00543803

Observational Non-interventional Study With Viramune® in Combination With Truvada® in HIV-infected Patients

An observational study of HIV Infections, run by Boehringer Ingelheim at 63 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: 334 participants
Where: 63 sitesGermany
Study dates: Feb 2006to Dec 2009
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: HIV Patients

Who may be able to join

male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Who cannot join

Age < 18 years
Pregnant female patients
Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) > 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised < 5 ULN.
Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT > 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine)
Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine
The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.

Trial locations and contacts

63 sites in 1 country.

City, postcode or hospital

63 sites in 1 country

Germany63 sites

Boehringer Ingelheim Investigational Site
Aachen
1100.1492.1 Boehringer Ingelheim Investigational Site
Berlin
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 1
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 1
Cologne
Boehringer Ingelheim Investigational Site 2
Cologne
Boehringer Ingelheim Investigational Site 3
Cologne
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site
Duisburg
Boehringer Ingelheim Investigational Site 1
Düsseldorf
Boehringer Ingelheim Investigational Site 2
Düsseldorf
Boehringer Ingelheim Investigational Site
Frankfurt (Oder)
Boehringer Ingelheim Investigational Site 1
Frankfurt am Main
Boehringer Ingelheim Investigational Site 2
Frankfurt am Main
Boehringer Ingelheim Investigational Site 3
Frankfurt am Main
Boehringer Ingelheim Investigational Site 4
Frankfurt am Main
Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 1
Hamburg
Boehringer Ingelheim Investigational Site 2
Hamburg
Boehringer Ingelheim Investigational Site 3
Hamburg
Boehringer Ingelheim Investigational Site 4
Hamburg
Boehringer Ingelheim Investigational Site 1
Hanover
Boehringer Ingelheim Investigational Site 2
Hanover
Boehringer Ingelheim Investigational Site
Karlsruhe
Boehringer Ingelheim Investigational Site
Koblenz
Boehringer Ingelheim Investigational Site 1
Leipzig
Boehringer Ingelheim Investigational Site 2
Leipzig
Boehringer Ingelheim Investigational Site
Magdeburg
Boehringer Ingelheim Investigational Site
Mainz
Boehringer Ingelheim Investigational Site
Mannheim
Boehringer Ingelheim Investigational Site 1
München
Boehringer Ingelheim Investigational Site 2
München
Boehringer Ingelheim Investigational Site 3
München
Boehringer Ingelheim Investigational Site 4
München
Boehringer Ingelheim Investigational Site 5
München
Boehringer Ingelheim Investigational Site 1
Münster
Boehringer Ingelheim Investigational Site 2
Münster
Boehringer Ingelheim Investigational Site 3
Münster
Boehringer Ingelheim Investigational Site 4
Münster
Boehringer Ingelheim Investigational Site 1
Nuremberg
Boehringer Ingelheim Investigational Site 2
Nuremberg
Boehringer Ingelheim Investigational Site
Oldenburg
Boehringer Ingelheim Investigational Site
Osnabrück
Boehringer Ingelheim Investigational Site
Potsdam
Boehringer Ingelheim Investigational Site
Saarbrücken
Boehringer Ingelheim Investigational Site 1
Stuttgart
Boehringer Ingelheim Investigational Site 2
Stuttgart
Boehringer Ingelheim Investigational Site 3
Stuttgart
Boehringer Ingelheim Investigational Site
Troisdorf
Boehringer Ingelheim Investigational Site
Wiesbaden
Boehringer Ingelheim Investigational Site
Wuppertal

Other trials in Germany

About this study

Official title: Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine

This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with 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 Truvada (tenofovir and emtricitabine).

Conditions: HIV Infections
Medical subject headings: HIV Infections

What is being measured

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

Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
The change in asparate aminotransferase (AST) from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Creatinine to Last Value on Treatment
The change in Creatinine from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
The change in total cholesterol from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Triglycerides to Last Value on Treatment
The change in triglycerides from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in Glucose to Last Value on Treatment
The change in Glucose from baseline to the last value in treatment
Measured: from baseline to last value on treatment in between 36 months

Secondary outcomes (4)

Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
For calculation of this measure switch patients are included in the total which had no viral load decrease.
Measured: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
Measured: from baseline to last value on treatment in between 36 months
Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
Total number of patients with investigator defined non-serious drug-related AEs was reported.
Measured: from baseline to last value on treatment in between 36 months
Investigator's Global Clinical Assessment of Patient General Health Status
Investigators opinion of patients general health condition at baseline versus last evaluation on treatment
Measured: from baseline to last value on treatment in between 36 months

Timeline

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

Feb 2006Dec 2009

First posted15 Oct 2007 (estimated)
Study startFeb 2006
Primary completionDec 2009

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: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00543803
Sponsor's protocol ID: 1100.1492
Status last verified: May 2014
First submitted: 8 Oct 2007
Last updated: 20 May 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 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Observational Non-interventional Study Evaluating the Safety and Efficacy of Truvada + Nevirapine
ClinicalTrials.gov ID: NCT00543803
Acronym / sponsor ID: 1100.1492
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Dec 2009 (actual)
First posted: 15 Oct 2007 (estimated)
Results: Posted 13 Jan 2011

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

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

Key inclusion criteria (3 listed)

male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection.
Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Key exclusion criteria (8 listed)

Age < 18 years
Pregnant female patients
Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine).
Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) > 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised < 5 ULN.

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

Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in asparate aminotransferase (AST) from baseline to the last value in treatment
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Summary of Change From Baseline in Creatinine to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in Creatinine from baseline to the last value in treatment
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in total cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Summary of Change From Baseline in Triglycerides to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in triglycerides from baseline to the last value in treatment
Summary of Change From Baseline in Glucose to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
The change in Glucose from baseline to the last value in treatment

4 secondary outcomes

Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
Time frame: from baseline to last value on treatment in between 36 months
Investigator's Global Clinical Assessment of Patient General Health Status
Time frame: from baseline to last value on treatment in between 36 months

Results and safety

Results posted to the registry on 13 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Treated With Viramune in Combination With Truvada	334	192

Primary outcome: Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment

Time frame: from baseline to last value on treatment in between 36 months. Median (Inter-Quartile Range). Unit: IU/L

Measure	Patients Treated With Viramune in Combination With Truvada n = 295
Value	1.0 (-3.0 to 7.0)

Population analysed: FAS- All patients were considered for the full analysis set.

Primary outcome: Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment

Time frame: from baseline to last value on treatment in between 36 months. Median (Inter-Quartile Range). Unit: IU/L

Measure	Patients Treated With Viramune in Combination With Truvada n = 317
Value	4.0 (-4.0 to 15.0)

Population analysed: FAS- All patients were considered for the full analysis set.

Primary outcome: Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment

Time frame: from baseline to last value on treatment in between 36 months. Median (Inter-Quartile Range). Unit: IU/L

Measure	Patients Treated With Viramune in Combination With Truvada n = 315
Value	23.0 (9.0 to 59.0)

Population analysed: FAS- All patients were considered for the full analysis set.

Primary outcome: Summary of Change From Baseline in Creatinine to Last Value on Treatment

Time frame: from baseline to last value on treatment in between 36 months. Median (Inter-Quartile Range). Unit: mg/dl

Measure	Patients Treated With Viramune in Combination With Truvada n = 312
Value	0.0 (-0.1 to 0.1)

Population analysed: FAS- All patients were considered for the full analysis set.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Treated With Viramune in Combination With Truvada	19 of 334 (5.7%)	19 of 334 (5.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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

63 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 63 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 3 inclusion and 8 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 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 13 Jan 2011). 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?

Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment (time frame: from baseline to last value on treatment in between 36 months). The study lists 9 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 NCT00543803.

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 20 May 2014.