NevirapineNCT00309582
Nevirapine Levels and Fluconazole
An observational study of Nevirapine and Fluconazole, run by Bamrasnaradura Infectious Diseases Institute.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Nevirapine, Fluconazole, Adverse Event
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy 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.
- Conditions
- Nevirapine, Fluconazole, Adverse Event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevirapineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Bamrasnaradura Infectious Diseases Institute
- Sponsor type
- Other government
- Investigators
- Weerawat Manosuthi, MD, Principal investigator, Bamrasnaradura Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309582
- Sponsor's protocol ID
- BIR2405
- Status last verified
- Nov 2005
- First submitted
- 30 Mar 2006
- Last updated
- 3 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Nevirapine Levels and Adverse Events Among HIV-Infected Patients Concurrently Receiving Nevirapine-Based Antiretroviral Therapy and Fluconazole
- ClinicalTrials.gov ID
- NCT00309582
- Acronym / sponsor ID
- BIR2405
- Conditions
- Nevirapine, Fluconazole, Adverse Event
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Bamrasnaradura Infectious Diseases InstituteOther government
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weerawat Manosuthi, MD principal investigator
Bamrasnaradura Infectious Diseases Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Nevirapine and Fluconazole, run by Bamrasnaradura Infectious Diseases Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2006.