HIV InfectionsNCT01134939

Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data

An observational study of HIV Infections, run by Boehringer Ingelheim at 34 sites in Germany.

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 years and older
Conditions the study is for: HIV Infections
How many people: 265 participants
Where: 34 sitesGermany
Study dates: May 2010to 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

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

Who cannot join

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

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

Germany34 sites

Boehringer Ingelheim Investigational Site 23
Aachen
Boehringer Ingelheim Investigational Site 10
Berlin
Boehringer Ingelheim Investigational Site 11
Berlin
Boehringer Ingelheim Investigational Site 14
Berlin
Boehringer Ingelheim Investigational Site 19
Berlin
Boehringer Ingelheim Investigational Site 26
Berlin
Boehringer Ingelheim Investigational Site 28
Berlin
Boehringer Ingelheim Investigational Site 33
Berlin
Boehringer Ingelheim Investigational Site 4
Berlin
Boehringer Ingelheim Investigational Site 5
Berlin
Boehringer Ingelheim Investigational Site 8
Berlin
Boehringer Ingelheim Investigational Site 9
Berlin
Boehringer Ingelheim Investigational Site 31
Chemnitz
Boehringer Ingelheim Investigational Site 25
Cologne
Boehringer Ingelheim Investigational Site 29
Dortmund
Boehringer Ingelheim Investigational Site 27
Düsseldorf
Boehringer Ingelheim Investigational Site 17
Frankfurt
Boehringer Ingelheim Investigational Site 1
Frankfurt
Boehringer Ingelheim Investigational Site 2
Freiburg im Breisgau
Boehringer Ingelheim Investigational Site 34
Giessen
Boehringer Ingelheim Investigational Site 22
Hamburg
Boehringer Ingelheim Investigational Site 6
Hamburg
Boehringer Ingelheim Investigational Site 12
Hanover
Boehringer Ingelheim Investigational Site 16
Hanover
Boehringer Ingelheim Investigational Site 32
Karlsruhe
Boehringer Ingelheim Investigational Site 15
Koblenz
Boehringer Ingelheim Investigational Site 21
Leipzig
Boehringer Ingelheim Investigational Site 20
München
Boehringer Ingelheim Investigational Site 24
München
Boehringer Ingelheim Investigational Site 3
München
Boehringer Ingelheim Investigational Site 7
München
Boehringer Ingelheim Investigational Site 13
Münster
Boehringer Ingelheim Investigational Site 18
Osnabrück
Boehringer Ingelheim Investigational Site 30
Stuttgart

Other trials in Germany

About this study

Official title: Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.

The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). 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 depending on gender 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

Time Perspective:

retro- and prospective

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 NCT01134939
Study group	Role	What they receive
HIV-infected women and men		Not described

What is being measured

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

Number of Patients With Virologic Response (VR) After 36 Months
VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart.
A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml.
Measured: 36 months

Secondary outcomes (12)

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 CD4+ Cell Count After 36 Months From Baseline
The change in the Cluster of differentiation 4 (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 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.

May 2010Dec 2013

First posted2 Jun 2010 (estimated)
Study startMay 2010
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
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134939
Sponsor's protocol ID: 1100.1536
Status last verified: Jan 2015
First submitted: 1 Jun 2010
Last updated: 21 Jan 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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Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Observational Study With Viramune® Plus Antiretroviral Backbone Combination in HIV-infected Women and Male Patients. Gender Specific Evaluation of Data.
ClinicalTrials.gov ID: NCT01134939
Acronym / sponsor ID: 1100.1536
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 2 Jun 2010 (estimated)
Results: Posted 21 Jan 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

Time Perspective:

retro- and prospective

Study design

Observational model: Cohort
Number of arms: 1

Arm	Type	Receives
HIV-infected women and men	–	–

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 for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC

Key exclusion criteria (1 listed)

The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/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 With Virologic Response (VR) After 36 Months
Time frame: 36 months
VR is defined as HIV viral load of < 50 copies/mL before month 36 and without subsequent rebound or change of ARV therapy. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart. A change of ARV therapy is defined as a permanent discontinuation of Viramune®. A change in the background therapy due to toxicity or intolerance is not considered failure for the analysis. Therefore, a patient remains a treatment responder in this case if all other criteria are fulfilled. A rebound is defined by two consecutive measurements of VL ≥ 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL< 50 copies/ml.

12 secondary outcomes

Changes in the Viral Load After 36 Months From Baseline
Time frame: Baseline and 36 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 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

Results posted to the registry on 21 Jan 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 Female Patients	59	42
Treatment-naive Male Patients	42	24
Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL	51	41
Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL	46	32
Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL	33	23
Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL	14	5
Female Patients, Baseline Viral Load Not Documented	19	10
Male Patients, Baseline Viral Load Not Documented	1	1

Primary outcome: Number of Patients With Virologic Response (VR) After 36 Months

Time frame: 36 months. Number. Unit: participants

Measure	Treatment-naive Female Patients n = 58	Treatment-naive Male Patients n = 42	Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL n = 51	Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL n = 46	Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL n = 33	Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL n = 14	Female Patients, Baseline Viral Load Not Documented n = 18	Male Patients, Baseline Viral Load Not Documented n = 1
Value	44	30	46	40	25	6	16	1

Population analysed: Patients from Full Analysis Set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.

12 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
Treatment-naive Patients	7 of 101 (6.9%)	46 of 101 (45.5%)	Not reported
Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL	10 of 97 (10.3%)	56 of 97 (57.7%)	Not reported
Pretreated Patients, Baseline Viral Load > 50 Copies/mL	4 of 47 (8.5%)	24 of 47 (51.1%)	Not reported
Patients With Baseline Viral Load Not Documented	1 of 20 (5%)	8 of 20 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

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RecruitingPhase 2
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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

34 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 34 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 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 21 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 34 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 21 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 Patients With Virologic Response (VR) After 36 Months (time frame: 36 months). 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 NCT01134939.

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 21 Jan 2015.