Nevirapine Levels and Fluconazole

This study has been completed.
Sponsor:
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT00309582
First received: March 30, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted

March 30, 2006
March 30, 2006
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Nevirapine Levels and Fluconazole
Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy and Fluconazole

Nevirapine (NVP)-based antiretroviral therapy (ART) has been commonly used in many developing countries due to its affordability and feasibility. Nonetheless, the potential drug-drug interaction between NVP and fluconazole (FLU) is a major concern. NVP can induce cytochrome P450 isoenzymes in the liver while FLU inhibit the activity of this enzyme. The recent report has demonstrated that fluconazole significantly raises plasma NVP levels and may cause serious hepatotoxicity. Conversely, NVP does not significantly influence the plasma level of FLU. However, there have not been enough data or any recommendations to adjust NVP dosage for the concurrent use of both drugs in order to avoid the adverse events. A previous study has demonstrated that genetic disposition may play a role in NVP hypersensitivity reactions. There is little data of safety and tolerability for concurrent use of NVP and FLU in Asian populations. We therefore conducted this prospective observational study to compare the trough plasma NVP levels and frequencies of adverse events among antiretroviral HIV-infected patients who did not receive FLU and received FLU in different dosages for cryptococcosis prophylaxis or treatment; and subsequently received NVP-based ART regimens.

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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Nevirapine
  • Fluconazole
  • Adverse Event
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria:

  1. HIV-infected patients >15 years of age,
  2. naïve to antiretroviral therapy,
  3. were initiated with a NVP-based ART regimen,
  4. used NVP 200-mg once-daily lead-in dose, prior to escalation to 200 mg twice daily.

Exclusion Criteria:

  1. creatinine level was higher than 2.0 mg/ml
  2. liver aminotransferase enzyme was higher than five times of upper normal limit
  3. receiving a medication that has drug-drug interactions with NVP or FLU
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00309582
BIR2405
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Bamrasnaradura Infectious Diseases Institute
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Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute
Bamrasnaradura Infectious Diseases Institute
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP