Case-Control Viramune (Nevirapine) Toxicogenomics Study

An observational study of HIV Infections, run by Boehringer Ingelheim at 102 sites in 11 countries.

Completed

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

Trial summary

Attempt to identify genetic polymorphisms in interrogated pathways which may be associated with symptomatic hepatotoxicity or severe cutaneous toxicity observed in case patients within the first 8 weeks of nevirapine therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: Nevirapine
How many people: 889 participants
Where: 102 sitesin 11 countries
Study dates: Feb 2006to Sep 2008
Phase: Observational
Are there results?: None posted in the registry

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 Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

Who may be able to join

Male or female patients >=18 years of age with HIV-1 infection who experienced one or more of the following adverse reactions within the first 8 weeks of starting nevirapine therapy:
Grade 3 or 4 LFT elevation (ALT or AST > 5X ULN) and any symptom consistent with clinical hepatitis (see Appendix 10.1)
Acute liver failure secondary to nevirapine therapy*
Functional group III or IV rash
*Acute liver failure is defined as serious liver injury usually requiring hospitalization that may lead to death or liver transplantation.
Male or female patients >=18 years of age with HIV-1 infection who have been exposed to nevirapine therapy for at least 18 weeks and who do not meet any of the case inclusion criteria

Who cannot join

Patients with any hepatotoxicity or rash event which in the investigators judgement is not related to nevirapine use (ex. hepatotoxicity due to alcohol or other medicinal use or rash due to other medicinal use).
Patients who began abacavir or TMP-SMX (trimethoprim/sulfamethoxazole) therapy 2 weeks or less prior to or up to 8 weeks after initiating nevirapine therapy.
Patients with AST or ALT elevations > 5 times the ULN (>= Grade 3) just prior to the initiation of nevirapine therapy.
Patients who discontinued nevirapine before completing 18 weeks of dosing with 200 mg/day for 2 weeks followed by 400 mg/day thereafter.
Patients who developed functional group I, IIa or IIb rash within 18 weeks of starting nevirapine therapy, or any dermatologic condition that could plausibly be attributed to nevirapine.
Patients with ALT or AST elevations >2.5 X ULN (>Grade 1) within 18 weeks of starting nevirapine therapy.

Show all 15Show fewer

Any hepatobiliary adverse event that could possibly be attributed to nevirapine.
Patients who develop any systemic reaction attributable to nevirapine use during the first 18 weeks of nevirapine treatment such as flu-like symptoms, arthralgia, myalgia, or conjunctivitis.
Patients who have participated in the 2NN-Long-term Follow-up study (1100.1454)
Patients with CD4 count 150 cells/mm3 prior to the initiation of nevirapine therapy (last available result measured 6 months prior to the initiation of nevirapine therapy).
Evidence of acute co-infection with viral hepatitis.
Patients taking prednisone, prednisolone, or immuno-modulatory medication within the first 8 weeks of nevirapine therapy.
Patients who are unwilling to provide blood samples for DNA testing.
Patients who did not sign informed consent and or authorization to release protected health information per local requirements.
Patients without available liv

Trial locations and contacts

102 sites in 11 countries.

Country

City, postcode or hospital

102 sites in 11 countries

France33 sites

1100.1452.3304A Hôpital Saint André
Bordeaux
1100.1452.3306A Hôpital Hôtel Dieu
Lyon
1100.1452.3306B Hop Hôtel Dieu
Lyon
1100.1452.3311A Hôpital Edouard Herriot
Lyon
1100.1452.3311B Pavillon P
Lyon
1100.1452.3311C Hôpital Edouard Herriot
Lyon
1100.1452.3311D Hôpital Edouard Herriot
Lyon
1100.1452.3305A Hôpital hôtel Dieu
Nantes
1100.1452.3305B Hôpital hôtel Dieu
Nantes
1100.1452.3305C Hôpital hôtel Dieu
Nantes
1100.1452.3305D Hôpital Hôtel Dieu
Nantes
1100.1452.3305E Hôpital hôtel Dieu
Nantes
1100.1452.3305F Hôpital Hôtel Dieu
Nantes
1100.1452.3305G Hôpital Hôtel Dieu
Nantes
1100.1452.3305H Hôpital hôtel Dieu
Nantes
1100.1452.3305I Hôpital Hôtel Dieu
Nantes
1100.1452.3301A Hôpital Saint Louis
Paris
1100.1452.3302A Hôpital Tenon
Paris
1100.1452.3303A Hôpital de la Pité Salpêtrière
Paris
1100.1452.3310A Hôpital Bichat Claude Bernard
Paris
1100.1452.3310B Hôpital Bichat Claude Bernard
Paris
1100.1452.3313A Hôpital Saint Antoine
Paris
1100.1452.3313B Hôpital Saint Antoine
Paris
1100.1452.3313C Hôpital Saint Antoine
Paris
1100.1452.3314A Hôpital Européen Georges Pompidou
Paris
1100.1452.3308A Hôpital Purpan
Toulouse
1100.1452.3308B Hôpital Purpan
Toulouse
1100.1452.3307A Hôpital Guy Chateliez
Tourcoing
1100.1452.3307B Hôpital Guy Chateliez
Tourcoing
1100.1452.3307C Hôpital Guy Chateliez
Tourcoing
1100.1452.3307D Hôpital Guy Chateliez
Tourcoing
1100.1452.3307E Hôpital Guy Chateliez
Tourcoing
1100.1452.3312A Hôpital Brabois
Vandœuvre-lès-Nancy

Other trials in France

Germany13 sites

1100.1452.4901 Boehringer Ingelheim Investigational Site
Berlin
1100.1452.4902 Boehringer Ingelheim Investigational Site
Berlin
1100.1452.9907 Boehringer Ingelheim Investigational Site
Berlin
1100.1452.4903 Boehringer Ingelheim Investigational Site
Bochum
1100.1452.4918 Boehringer Ingelheim Investigational Site
Bonn
1100.1452.4912 Boehringer Ingelheim Investigational Site
Düsseldorf
1100.1452.4904 Boehringer Ingelheim Investigational Site
Essen
1100.1452.4933 Boehringer Ingelheim Investigational Site
Frankfurt am Main
1100.1452.4916 Boehringer Ingelheim Investigational Site
Hamburg
1100.1452.4931 Boehringer Ingelheim Investigational Site
Hamburg
1100.1452.4910 Boehringer Ingelheim Investigational Site
München
1100.1452.4900 Universitätsklinikum Ulm
Ulm
1100.1452.4932 Boehringer Ingelheim Investigational Site
Würzburg

Other trials in Germany

United States12 sites

1100.1452.99999 Boehringer Ingelheim Investigational Site
Baltimore, Connecticut
1100.1452.01003 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1100.1452.01006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1100.1452.01002 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1100.1452.01012 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
1100.1452.01013 Boehringer Ingelheim Investigational Site
Denver, Colorado
1100.1452.01004 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1100.1452.01001 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1100.1452.01011 Boehringer Ingelheim Investigational Site
New Haven, Connecticut
1100.1452.01016 Boehringer Ingelheim Investigational Site
New York, New York
1100.1452.01014 Boehringer Ingelheim Investigational Site
Springfield, Massachusetts
1100.1452.01015 Boehringer Ingelheim Investigational Site
St Louis, Missouri

Other trials in United States

Spain10 sites

1100.1452.34005 Boehringer Ingelheim Investigational Site
Badalona
1100.1452.34001 Boehringer Ingelheim Investigational Site
Barcelona
1100.1452.34002 Boehringer Ingelheim Investigational Site
Barcelona
1100.1452.34004 Boehringer Ingelheim Investigational Site
Barcelona
1100.1452.34003 Boehringer Ingelheim Investigational Site
L'Hospitalet de Llobregat
1100.1452.34006 Boehringer Ingelheim Investigational Site
Madrid
1100.1452.34007 Boehringer Ingelheim Investigational Site
Madrid
1100.1452.34010 Boehringer Ingelheim Investigational Site
Madrid
1100.1452.34011 Boehringer Ingelheim Investigational Site
Madrid
1100.1452.34009 Boehringer Ingelheim Investigational Site
Seville

Other trials in Spain

United Kingdom9 sites

1100.1452.44006 Boehringer Ingelheim Investigational Site
Birmingham
1100.1452.44004 Boehringer Ingelheim Investigational Site
Brighton
1100.1452.44001 Boehringer Ingelheim Investigational Site
Coventry
1100.1452.44002 Boehringer Ingelheim Investigational Site
London
1100.1452.44005 Boehringer Ingelheim Investigational Site
London
1100.1452.44008 Boehringer Ingelheim Investigational Site
London
1100.1452.44009 Boehringer Ingelheim Investigational Site
London
1100.1452.44003 Boehringer Ingelheim Investigational Site
Manchester
1100.1452.44007 Boehringer Ingelheim Investigational Site
Plaistow, London

Other trials in United Kingdom

Australia7 sites

1100.1452.61002 Boehringer Ingelheim Investigational Site
Carlton, Victoria
1100.1452.61004 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
1100.1452.61005 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
1100.1452.61006 Boehringer Ingelheim Investigational Site
Darlinghurst, New South Wales
1100.1452.61008 Boehringer Ingelheim Investigational Site
Melbourne, Victoria
1100.1452.61003 Boehringer Ingelheim Investigational Site
Miami, Queensland
1100.1452.61001 Boehringer Ingelheim Investigational Site
South Yarra, Victoria

Other trials in Australia

Taiwan6 sites

1100.1452.88602 Kaohsiung Veterans General Hospital
Kaohsiung City
1100.1452.88603 E-Da Hospital
Kaohsiung City
1100.1452.88605 Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City
1100.1452.88606 China Medical University Hospital
Taichung
1100.1452.88601 National Taiwan University Hospital
Taipei
1100.1452.88604 Taipei City Hospital
Taipei

Other trials in Taiwan

Argentina4 sites

1100.1452.54001 Fundación Huésped
Capital Federal
1100.1452.54002 Funcei
Capital Federal
1100.1452.54003 Boehringer Ingelheim Investigational Site
Capital Federal
1100.1452.54004 Boehringer Ingelheim Investigational Site
Rosario

Other trials in Argentina

Canada3 sites

1100.1452.01502 Toronto General Hospital
Toronto, Ontario
1100.1452.01501 St. Paul's Hospital
Vancouver, British Columbia
1100.1452.01504 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Thailand3 sites

1100.1452.66001 Boehringer Ingelheim Investigational Site
Bangkok
1100.1452.66002 Boehringer Ingelheim Investigational Site
Bangkok
1100.1452.66003 Boehringer Ingelheim Investigational Site
Khon Kaen

Other trials in Thailand

Netherlands2 sites

1100.1452.31001 Academisch Medisch Centrum
Amsterdam
1100.1452.31002 Onze Lieve Vrouwen Gasthuis
Amsterdam

Other trials in Netherlands

About this study

Official title: A Case-Control Toxicogenomics Study to Identify Unique Genetic Polymorphisms in Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

Conditions: HIV Infections
Being tested: Nevirapine
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NevirapineDrug
Patients with HIV-1 infection who have taken or are currently taking nevirapine

Study groups in NCT00310843
Study group	Role	What they receive
All study population		Not described Receives: Drug: Nevirapine

What is being measured

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

Endpoints: relationship between nevirapine-related AEs and genetic polymorphisms loci: Drug metabolizing enzymes (e.g., cytochrome P450 isoforms) Drug transporters (e.g., MDR1 and OATP-C) Human Major Histocompatibility Complex region genes

Secondary outcomes (1)

Descriptive demographics comparing cases with matched controls in an attempt to link genetic polymorphisms associated with symptomatic hepatotoxicity or severe cutaneous toxicity (cases) to gender, race or other patient characteristics.

Timeline

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

Feb 2006Sep 2008

First posted5 Apr 2006 (estimated)
Study startFeb 2006
Primary completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Case-control
Time perspective: Retrospective
Enrolment: 889 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00310843
Sponsor's protocol ID: 1100.1452
Other IDs: 2005-004321-26, 2005
Status last verified: Jul 2013
First submitted: 28 Mar 2006
Last updated: 1 Aug 2013
Results posted: No

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 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Case-Control Toxicogenomics Study to Identify Unique Genetic Polymorphisms in Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy
ClinicalTrials.gov ID: NCT00310843
Acronym / sponsor ID: 1100.1452
Conditions: HIV Infections
Study type: Observational
Recruitment status: Completed
Enrolment: 889 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Sep 2008 (actual)
First posted: 5 Apr 2006 (estimated)
Results: Not posted in the source record

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: Case-control
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
All study population	–	Drug: Nevirapine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients Who Have Experienced Symptomatic Hepatotoxicity or Severe Cutaneous Toxicity Within the First 8 Weeks of Nevirapine Therapy

Key inclusion criteria (6 listed)

Male or female patients >=18 years of age with HIV-1 infection who experienced one or more of the following adverse reactions within the first 8 weeks of starting nevirapine therapy:
Male or female patients >=18 years of age with HIV-1 infection who have been exposed to nevirapine therapy for at least 18 weeks and who do not meet any of the case inclusion criteria

Key exclusion criteria (15 listed)

Patients with any hepatotoxicity or rash event which in the investigators judgement is not related to nevirapine use (ex. hepatotoxicity due to alcohol or other medicinal use or rash due to other medicinal use).
Patients who began abacavir or TMP-SMX (trimethoprim/sulfamethoxazole) therapy 2 weeks or less prior to or up to 8 weeks after initiating nevirapine therapy.
Patients with AST or ALT elevations > 5 times the ULN (>= Grade 3) just prior to the initiation of nevirapine therapy.
Patients who discontinued nevirapine before completing 18 weeks of dosing with 200 mg/day for 2 weeks followed by 400 mg/day thereafter.
Patients who developed functional group I, IIa or IIb rash within 18 weeks of starting nevirapine therapy, or any dermatologic condition that could plausibly be attributed to nevirapine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NevirapinePatients with HIV-1 infection who have taken or are currently taking nevirapine	Drug	All study population

Primary outcome

Endpoints: relationship between nevirapine-related AEs and genetic polymorphisms loci: Drug metabolizing enzymes (e.g., cytochrome P450 isoforms) Drug transporters (e.g., MDR1 and OATP-C) Human Major Histocompatibility Complex region genes

1 secondary outcome

Descriptive demographics comparing cases with matched controls in an attempt to link genetic polymorphisms associated with symptomatic hepatotoxicity or severe cutaneous toxicity (cases) to gender, race or other patient characteristics.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
Related InfoLink provided by the sponsor.

Related trials for HIV Infections

RecruitingObservational study
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HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

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

102 sites in 11 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 102 sites in 11 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 6 inclusion and 15 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 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in France, Germany, United States, Spain, United Kingdom and 6 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Endpoints: relationship between nevirapine-related AEs and genetic polymorphisms loci: Drug metabolizing enzymes (e.g., cytochrome P450 isoforms) Drug transporters (e.g., MDR1 and OATP-C) Human Major Histocompatibility Complex region genes. 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 NCT00310843.

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 1 Aug 2013.