Nevirapine Levels and Fluconazole
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00309582 |
Recruitment Status
:
Completed
First Posted
: April 3, 2006
Last Update Posted
: April 3, 2006
|
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Condition or disease |
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Nevirapine Fluconazole Adverse Event |
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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Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309582
Principal Investigator: | Weerawat Manosuthi, MD | Bamrasnaradura Infectious Diseases Institute |
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 |