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Case-Control Viramune (Nevirapine) Toxicogenomics Study | Clinical Trials | Clareo Health

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Case-Control Viramune (Nevirapine) Toxicogenomics Study

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

NCT00310843•Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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.
+8 more criteria

Locations (102)

1100.1452.01006 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

1100.1452.01013 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

1100.1452.99999 Boehringer Ingelheim Investigational Site

Baltimore, Connecticut, United States

1100.1452.01011 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

1100.1452.01003 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

1100.1452.01002 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

1100.1452.01014 Boehringer Ingelheim Investigational Site

Springfield, Massachusetts, United States

1100.1452.01015 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1100.1452.01016 Boehringer Ingelheim Investigational Site

New York, New York, United States

1100.1452.01012 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Key Dates

Start Date

February 1, 2006

Primary Completion Date

September 1, 2008

Last Updated

August 1, 2013

Enrollment

889

ACTUAL participants

Conditions

HIV Infections

Interventions

Nevirapine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Case-Control Viramune (Nevirapine) Toxicogenomics Study

Inclusion Criteria

Exclusion Criteria

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