Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014014
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2001-04-07
Brief Title:
Zidovudine and Lamivudine Given Once Versus Twice Daily
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Pharmacokinetic Study of Once Versus Twice Daily Dosing With Zidovudine and Lamivudine
Status:
COMPLETED
Status Verified Date:
2013-10
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:
The purpose of this study is to see if the full daily dose of Combivir zidovudine ZDVlamivudine 3TC taken once a day is as effective as the usual recommended twice-a-day dose
Studies have shown that the antiviral activity of ZDV can continue in the body even after there does not appear to be any ZDV left in the blood This occurs because the body breaks down the drug into substances that remain active against HIV The body also breaks down 3TC a drug that is combined with ZDV in the Combivir product in a similar way Since antiviral activity may continue after Combivir is removed from the body it may not be necessary to take the drug as often as once thought This study carefully measures levels of the active substances in order to find out whether the same amount of antiviral activity occurs with less-frequent dosing
Studies have shown that the antiviral activity of ZDV can continue in the body even after there does not appear to be any ZDV left in the blood This occurs because the body breaks down the drug into substances that remain active against HIV The body also breaks down 3TC a drug that is combined with ZDV in the Combivir product in a similar way Since antiviral activity may continue after Combivir is removed from the body it may not be necessary to take the drug as often as once thought This study carefully measures levels of the active substances in order to find out whether the same amount of antiviral activity occurs with less-frequent dosing
Detailed Description:
Initial dosing regimens of ZDV were based on the plasma half-life of the drug However recent studies of the intracellular metabolism of ZDV have demonstrated that the active anabolite ZDV-TP is present within the cell for an extended period of time relative to the drug in the plasma This suggests that antiviral activity may be present for a sufficient time frame with less-frequent dosing of the drug Careful comparison of the rate and extent of intracellular phosphorylated ZDV metabolites as a function of schedule will determine whether less-frequent dosing has a sound pharmacological basis Also the intracellular metabolism of 3TC is via different enzymes than that of ZDV and there are quantitative differences in the amount of triphosphate formed from both drugs This study will provide information about intracellular metabolites when both ZDV and 3TC are concurrently administered
This is a study of 2 schedules of Combivir therapy At study entry or Part I all patients take Combivir twice daily for the 7-day adherence assessment Patients who have demonstrated 70 percent or greater adherence AS PER AMENDMENT 72001 70 percent compliance with the study regimen for Combivir This corresponds to taking at least 10 of the prescribed 14 Combivir tablets during the 7 days prior to an adherence assessment including all scheduled doses in the 24-hour period prior to that assessment and have taken all scheduled Combivir doses in the previous 24 hours have pharmacokinetic samples obtained and are randomized to Group A or Group B in Part II Group A patients take 2 Combivir tablets once daily Group B patients take 1 Combivir tablet twice daily After patients have completed the targeted duration of Part II 7 days for Group A and 7-14 days for Group B they are assessed for adherence Patients who have demonstrated 70 percent or greater adherence and have taken all scheduled Combivir doses in the previous 24 hours have pharmacokinetic samples obtained and then change to the alternate dosing schedule Group A patients take 1 Combivir tablet twice daily Group B patients take 2 Combivir tablets once daily After patients have completed the targeted duration of Part III 7-14 days for Group A and 7 days for Group B they are assessed for adherence All patients who meet the adherence criteria have pharmacokinetic samples obtained After completion of Part III pharmacokinetic studies patients have completed the study Note Combivir will not be provided in this study
This is a study of 2 schedules of Combivir therapy At study entry or Part I all patients take Combivir twice daily for the 7-day adherence assessment Patients who have demonstrated 70 percent or greater adherence AS PER AMENDMENT 72001 70 percent compliance with the study regimen for Combivir This corresponds to taking at least 10 of the prescribed 14 Combivir tablets during the 7 days prior to an adherence assessment including all scheduled doses in the 24-hour period prior to that assessment and have taken all scheduled Combivir doses in the previous 24 hours have pharmacokinetic samples obtained and are randomized to Group A or Group B in Part II Group A patients take 2 Combivir tablets once daily Group B patients take 1 Combivir tablet twice daily After patients have completed the targeted duration of Part II 7 days for Group A and 7-14 days for Group B they are assessed for adherence Patients who have demonstrated 70 percent or greater adherence and have taken all scheduled Combivir doses in the previous 24 hours have pharmacokinetic samples obtained and then change to the alternate dosing schedule Group A patients take 1 Combivir tablet twice daily Group B patients take 2 Combivir tablets once daily After patients have completed the targeted duration of Part III 7-14 days for Group A and 7 days for Group B they are assessed for adherence All patients who meet the adherence criteria have pharmacokinetic samples obtained After completion of Part III pharmacokinetic studies patients have completed the study Note Combivir will not be provided in this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PACTG P1012 | None | None | None |
| ACTG P1012 | None | None | None |
| 11648 | REGISTRY | DAIDS ES | None |