Nevirapine Levels and Fluconazole

Adverse Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00309582
• Other study ID #: BIR2405
• Status: Completed
• Phase: N/A
• First received: March 30, 2006
• Last updated: March 30, 2006

Study information

• Verified date: November 2005
• Source: Bamrasnaradura Infectious Diseases Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Adverse Event
• Fluconazole
• Nevirapine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bamrasnaradura Infectious Diseases Institute