Nevirapine Levels and Fluconazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Brief Summary

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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

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Conditions

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Nevirapine Fluconazole Adverse Event

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Weerawat Manosuthi, MD

Role: PRINCIPAL_INVESTIGATOR

Bamrasnaradura Infectious Diseases Institute

Other Identifiers

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BIR2405

Identifier Type: -

Identifier Source: org_study_id