Nevirapine Levels and Fluconazole - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 30, 2006

Last Updated Date

March 30, 2006

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Nevirapine Levels and Fluconazole

Official Title ^†

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

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Longitudinal, Defined Population, Prospective Study

Condition ^†

Nevirapine
Fluconazole
Adverse Event

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00309582

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Bamrasnaradura Infectious Diseases Institute

Collaborators ^††

Investigators ^†

Principal Investigator:

Weerawat Manosuthi, MD

Bamrasnaradura Infectious Diseases Institute

Information Provided By

Bamrasnaradura Infectious Diseases Institute

Verification Date

November 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.