Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight (NAWS)
![]() |
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: NCT01335360 |
Recruitment Status
:
Completed
First Posted
: April 14, 2011
Last Update Posted
: April 14, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
HIV Infection | Drug: Nevirapine |

Study Type : | Observational |
Actual Enrollment : | 21 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Pharmacokinetic Evaluation of Changes in Nevirapine AUC Due to Differences in Weight |
Study Start Date : | May 2003 |
Actual Primary Completion Date : | May 2003 |
Actual Study Completion Date : | June 2003 |

Group/Cohort | Intervention/treatment |
---|---|
Subjects >80kg
As above
|
Drug: Nevirapine
200mg twice daily of nevirapine
|
Subjects <70kg
As above
|
Drug: Nevirapine
200mg twice daily of nevirapine
|
Subjects 70-80kg
As above
|
Drug: Nevirapine
200mg twice daily of nevirapine
|
- 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.
Biospecimen Retention: None Retained

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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 …)

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): NCT01335360
United States, California | |
Jeffrey Goodman Clinic | |
Los Angeles, California, United States, 90028 |
Principal Investigator: | James D Scott, PharmD | Western University of Health Sciences |
Responsible Party: | James D. Scott, PharmD, Associate Professor, Western University |
ClinicalTrials.gov Identifier: | NCT01335360 History of Changes |
Other Study ID Numbers: |
WesternU |
First Posted: | April 14, 2011 Key Record Dates |
Last Update Posted: | April 14, 2011 |
Last Verified: | April 2011 |
Keywords provided by Western University of Health Sciences:
nevirapine pharmacokinetics |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Nevirapine |
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 |