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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00310843
Registration number
NCT00310843
Ethics application status
Date submitted
28/03/2006
Date registered
5/04/2006
Date last updated
1/08/2013
Titles & IDs
Public title
Case-Control Viramune (Nevirapine) Toxicogenomics Study
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Scientific 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
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Secondary ID [1]
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2005-004321-26
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Secondary ID [2]
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1100.1452
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV Infections
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Nevirapine
All study population -
Treatment: Drugs: Nevirapine
Patients with HIV-1 infection who have taken or are currently taking nevirapine
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
Inclusion for Case
1. 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.
Inclusion for Control
2. 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion for Cases
1. 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).
2. 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.
3. Patients with AST or ALT elevations > 5 times the ULN (>= Grade 3) just prior to the
initiation of nevirapine therapy.
Exclusion for Controls
4. Patients who discontinued nevirapine before completing 18 weeks of dosing with 200
mg/day for 2 weeks followed by 400 mg/day thereafter.
5. 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.
6. Patients with ALT or AST elevations >2.5 X ULN (>Grade 1) within 18 weeks of starting
nevirapine therapy.
7. Any hepatobiliary adverse event that could possibly be attributed to nevirapine.
8. 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.
Exclusion for Cases and Controls
9. Patients who have participated in the 2NN-Long-term Follow-up study (1100.1454)
10. 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).
11. Evidence of acute co-infection with viral hepatitis.
12. Patients taking prednisone, prednisolone, or immuno-modulatory medication within the
first 8 weeks of nevirapine therapy.
13. Patients who are unwilling to provide blood samples for DNA testing.
14. Patients who did not sign informed consent and or authorization to release protected
health information per local requirements.
15. Patients without available liv
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
889
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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1100.1452.61004 Boehringer Ingelheim Investigational Site - Darlinghurst
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Recruitment hospital [2]
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1100.1452.61005 Boehringer Ingelheim Investigational Site - DarlingHurst
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Recruitment hospital [3]
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1100.1452.61006 Boehringer Ingelheim Investigational Site - Darlinghurst
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1100.1452.61003 Boehringer Ingelheim Investigational Site - Miami
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Recruitment hospital [5]
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1100.1452.61002 Boehringer Ingelheim Investigational Site - Carlton
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Recruitment hospital [6]
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1100.1452.61008 Boehringer Ingelheim Investigational Site - Melbourne
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Recruitment hospital [7]
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1100.1452.61001 Boehringer Ingelheim Investigational Site - South Yarra
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Recruitment postcode(s) [1]
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- Darlinghurst
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Recruitment postcode(s) [2]
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- DarlingHurst
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Recruitment postcode(s) [3]
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- Miami
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Recruitment postcode(s) [4]
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- Carlton
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Recruitment postcode(s) [5]
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- Melbourne
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Recruitment postcode(s) [6]
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- South Yarra
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Connecticut
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Rosario
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Canada
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Ontario
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Bordeaux
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Lyon
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Nantes
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Plaistow, London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00310843
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00310843
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