- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01335360
Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight (NAWS)
Study Overview
Detailed Description
This will be a non-randomized, cohort study. 8 patients in each of 3 weight ranges (< 160lb, 161-200lb, > 200lb) will be recruited to participate in the study. Subjects will be HIV + patients currently on stable therapy with nevirapine (on medication for at least 3 months with minimal self-reported adherence) as part of a combination regimen for their Human Immunodeficiency Virus (HIV) infection (as prescribed by their primary care provider). Subjects are to be in good health with liver function tests will be < 2 times normal limits, measured within 1 month prior to the study period. All subjects will be male. The reasoning for this gender bias is as follows: if both genders are to be used, there should be an equal number of male and female subjects to remove any bias from the data. Since there are not enough females taking nevirapine to be able to appropriately recruit, females will be excluded.
Subjects will be asked to take their medications the night before the study period between 8:00pm and 8:30pm, and asked to abstain from alcohol for the 7 days prior to the study. On the study day, they will report to the Jeffrey Goodman Special Care Clinic at 7:30, prior to breakfast.
Subjects will randomly be divided into 4 groups during the study period. Four healthcare professionals (one physician, one family nurse practitioner, one registered nurse and one licensed vocational nurse, will be present throughout the study for catheter insertions and blood draws. IV catheters will be inserted upon arrival, with four patients (one from each group) having a time zero and receiving their study medication at each time point of 8:00, 8:05, 8:10, 8:15, 8:20, 8:25 (this is to allow for appropriate work-flow during the blood draw portion of the study. Serial blood samples will be drawn after dosing at the following times: 0.5hr, 1hr, 1.5hr, 2hr, 4hr, 6hr, 8hr, 12hr. Subjects will be allowed to eat breakfast (supplied by the study personnel) After the 1hr blood sample. Lunch and dinner will also be available for study subjects. 12hr sample, the catheters will be removed and the subjects allowed to leave (subjects will not be allowed to leave the premises with the catheter in place). Subjects will be paid $250 for their participation after the conclusion of the study.
Consolidated Laboratory Services will analyze all blood samples for nevirapine levels. AUC's and AUC comparisons will be calculated with appropriate statistical software (Systat).
Pharmacokinetic (PK) Levels:
Levels will be drawn prior to dosing, and at the following time intervals: 0.5hr, 1hr, 1.5hr, 2hr, 4hr, 6hr, 8hr, 12hr. ~10cc of blood will be drawn with each sample, centrifuged, and plasma separated into 2 cryovials. Samples will then be frozen at -20oC. All samples (216) will be sent to Consolidated Laboratory Services for level determination by appropriate means.
Safety monitoring:
A licensed physician and a licensed family nurse practitioner will be on site for the entire study. All study personnel are certified in Basic Life Support (and some in Advanced Cardiac Life Support). The clinic facilities are equipped for minor emergencies and 911 will be utilized for major emergencies.
Statistics:
AUC's will be calculated using non-linear mathematical modeling with statistical software. AUC's will be compared using appropriate statistical tests.
Evaluation of Adverse Events:
All adverse events will be recorded and treated (if necessary) on site. Adverse events not able to be treated on site will be referred to an emergency room or to their primary provider the following day (if it is not urgent).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90028
- Jeffrey Goodman Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- Documented HIV infection
- 18-50yrs of age
- Male
- Currently on nevirapine therapy for at least 3 months
- LFT's < 2 times normal limits within one month prior to study date
- In good health as judged by their primary care provider or a study provider within one month of the study date
- Willing to abstain for 1 week prior to study date
- No active opportunistic infections within one month prior to the study date
- Willingness to sign informed consent
Exclusion criteria:
- Active substance abuse
- Poor self reported adherence to nevirapine therapy
- Chronic liver disease or active hepatitis
- Concurrent administration of medications with a known or suspected pharmacokinetic drug interaction with nevirapine (such as …)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects >80kg
As above
|
200mg twice daily of nevirapine
|
Subjects <70kg
As above
|
200mg twice daily of nevirapine
|
Subjects 70-80kg
As above
|
200mg twice daily of nevirapine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences in AUC based on weight/BMI
Time Frame: 12 hours
|
This study was a "snapshot" of the PK levels following ingestion, and then compared AUC to weight and BMI.
|
12 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: James D Scott, PharmD, Western University of Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Nevirapine
Other Study ID Numbers
- WesternU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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