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OpenTrials
Completed

NCT Number: NCT00309582

Nevirapine Levels 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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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • creatinine level was higher than 2.0 mg/ml
  • liver aminotransferase enzyme was higher than five times of upper normal limit
  • receiving a medication that has drug-drug interactions with NVP or FLU

Sponsors and collaborators

Lead sponsor

Bamrasnaradura Infectious Diseases Institute

Other Gov

Registry information

Official study title

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

Important dates

First posted
Apr 3, 2006
Registry last updated
Apr 3, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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