Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054743
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-02-07
Brief Title:
Differences in Blood Levels of Nevirapine in HIV-infected Patients in Uganda and the United States
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Global Initiative to Characterize Differences in Antiretroviral Pharmacokinetics in HIV-Infected Populations
Status:
COMPLETED
Status Verified Date:
2011-04-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether blood levels of the anti-HIV medicine nevirapine are different in HIV-infected patients in the United States from patients in Uganda People from all over the world take medications to treat HIV infection These medicines work well in some people but not in others and they cause harmful side effects in some people and not in others These differences may be related to variations in how much of the drug reaches the blood Differences in drug blood levels among people in various areas of the world may be attributed to differences in diet state of health ability to absorb the medicines from the stomach ability to eliminate the drugs from the body and the brand of medicine taken This study will help scientists learn whether differences in blood levels of HIV medicines are important in determining how well the drugs work in different patient populations
HIV-infected patients 18 years of age and older in the United States and in Kampala Uganda who have been on an antiretroviral treatment regimen that includes at least 28 consecutive days of nevirapine may be eligible for this study Candidates will be screened with a medical history physical examination and blood tests
Participants will have a total of approximately about 5 ounces of blood drawn during this 6- to 8-hour study They will come to the NIH clinic in the morning and a catheter plastic tube will be inserted into an arm vein for collecting blood Alternatively blood can be collected by a needle inserted into an arm vein Blood will be withdrawn according to the following schedule
About 5 tablespoons will be collected upon arrival at the clinic after an overnight fast Within 30 minutes of this blood draw the patient will have breakfast and take his or her morning dose of nevirapine along with any other medications that need to be taken at that time
1 tablespoon of blood will be drawn 2 hours after the nevirapine dose
1 tablespoon of blood will be drawn 4 hours later 6 hours after the nevirapine dose
The blood will be analyzed for levels of nevirapine and possibly other HIV medicines Some of the blood will be stored for later analysis of genes cytochrome P450 and MDR1 that are involved in eliminating medicines from the body
HIV-infected patients 18 years of age and older in the United States and in Kampala Uganda who have been on an antiretroviral treatment regimen that includes at least 28 consecutive days of nevirapine may be eligible for this study Candidates will be screened with a medical history physical examination and blood tests
Participants will have a total of approximately about 5 ounces of blood drawn during this 6- to 8-hour study They will come to the NIH clinic in the morning and a catheter plastic tube will be inserted into an arm vein for collecting blood Alternatively blood can be collected by a needle inserted into an arm vein Blood will be withdrawn according to the following schedule
About 5 tablespoons will be collected upon arrival at the clinic after an overnight fast Within 30 minutes of this blood draw the patient will have breakfast and take his or her morning dose of nevirapine along with any other medications that need to be taken at that time
1 tablespoon of blood will be drawn 2 hours after the nevirapine dose
1 tablespoon of blood will be drawn 4 hours later 6 hours after the nevirapine dose
The blood will be analyzed for levels of nevirapine and possibly other HIV medicines Some of the blood will be stored for later analysis of genes cytochrome P450 and MDR1 that are involved in eliminating medicines from the body
Detailed Description:
The overwhelming majority of HIV-infected persons reside in the developing world As such recent efforts have focused on providing antiretroviral pharmacotherapy to this population However there are a number of factors indigenous to non-Western HIV-infected patients that may alter their virologic immunologic andor toxicologic response to antiretroviral therapy Absorption distribution and clearance of antiretroviral medications may differ among patients residing in non-Western countries secondary to dietary influences parasitic infection and malabsorption Genetic polymorphisms of drug metabolizing enzymes cytochrome P450 CYP and drug transporters ie P-glycoprotein may also contribute to altered pharmacokinetics among these patients The purpose of this pilot hypothesis-generating study is 1 to characterize the pharmacokinetics of the non-nucleoside reverse transcriptase inhibitor nevirapine in a non-Western HIV-infected population Kampala Uganda and in a similar cohort of HIV-infected individuals in the United States and 2 to compare pharmacokinetic parameter values between the groups Twenty-five subjects from each site will participate Subjects from the Ugandan site may participate regardless of their CD4 lymphocyte count and viral load they will be studied prior to the US cohort The US group will be selected to include subjects that are matched by gender to their Ugandan counterparts Subjects will have one pre-dose and two post-dose blood samples collected for the determination of nevirapine plasma concentrations Samples will be analyzed using LCMS-MS Population pharmacokinetics parameter values Cmax Cmin AUC CLF Vd will be determined using NONMEMTrademark and compared between groups Blood samples collected during the study will also be used to determine CYP and MDR1 genotypes of study subjects in an effort to explain any observed differences in pharmacokinetics parameter values between the study populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-CC-0091 | None | None | None |