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Nevirapine Levels and Fluconazole

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ClinicalTrials.gov Identifier: NCT00309582
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : April 3, 2006
Sponsor:
Information provided by:
Bamrasnaradura Infectious Diseases Institute

Study Description
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Brief Summary:
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.

Condition or disease
Nevirapine Fluconazole Adverse Event

Study Design
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Study Type : Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy and Fluconazole

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309582


Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Investigators
Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute
More Information
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ClinicalTrials.gov Identifier: NCT00309582     History of Changes
Other Study ID Numbers: BIR2405
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: April 3, 2006
Last Verified: November 2005

Additional relevant MeSH terms:
Nevirapine
Fluconazole
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP3A Inducers
 Cytochrome P-450 Enzyme Inducers
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors