Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000877
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
Study of How Indinavir an Anti-HIV Drug and Rifabutin a Drug Used to Treat MAC an HIV-Associated Disease Interact in HIV-Positive and HIV-Negative Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Steady-State Pharmacokinetic Interaction Study of Indinavir and Rifabutin
Status:
COMPLETED
Status Verified Date:
2021-10
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 evaluate the safety of giving indinavir and rifabutin at the same time simultaneously vs 4 hours apart staggered to HIV-positive and HIV-negative adults
It is important to determine which medications for HIV-associated diseases such as Mycobacterium avium complex MAC disease can be given safely and effectively with anti-HIV drugs Indinavir and rifabutin have been given simultaneously in the past with good results This study seeks to examine if staggering the doses will make the 2 drugs more effective HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients
It is important to determine which medications for HIV-associated diseases such as Mycobacterium avium complex MAC disease can be given safely and effectively with anti-HIV drugs Indinavir and rifabutin have been given simultaneously in the past with good results This study seeks to examine if staggering the doses will make the 2 drugs more effective HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients
Detailed Description:
Currently rifabutin is the only rifamycin that can be administered with indinavir ACTG 365 is the first formal study of the pharmacokinetics of this dosing combination regimen in HIV seropositive patients It is hypothesized that staggered administration of rifabutin and indinavir might minimize their pharmacokinetic interaction If the intestinal tract plays a significant role in the presystemic clearance of rifabutin the inhibitory activity of indinavir on rifabutin could depend on either luminal concentrations of indinavir systematic concentrations of indinavir or both If luminal concentrations are important then the interaction between these 2 drugs will be maximal when administered simultaneously and minimal when their oral administration is staggered Finally since indinavir has a half-life of 18 hours its effects on rifabutins systematic clearance may be much less when administration of these drugs is staggered by 4 hours as compared with simultaneous administration with rifabutin If the interaction on rifabutin is minimized then the rifabutin levels may be suboptimal for treatment of tuberculosis in patients who are not administered the 2 drugs simultaneously It is therefore important to define the magnitude of the effect of staggered vs simultaneous drug administration in order to clarify dose and regimen recommendations in HIV-infected patients with tuberculosis who also require protease inhibitor therapy
Study Arm A is a multiple-dose 3-period sequential study in 18 evaluable HIV-infected indinavir-naive male and female volunteers AS PER AMENDMENT 111698 Arm A will be assessed in 18 evaluable HIV-seronegative patients Patients receive 3 different treatments consisting of 14 days of administration rifabutin alone Period IA indinavir plus rifabutin Period IIA and indinavir plus rifabutin Period IIIA Study Arm B is a multiple-dose 2-period sequential study in 10 evaluable HIV-infected male and female volunteers Patients receive 2 different treatments each consisting of 14 days of administration indinavir alone Period IB and indinavir plus rifabutin Period IIB Patients on both arms take each dose of their study medications with water AS PER AMENDMENT 8897 Patients treated on Arm A are randomized following Period IA therapy to Period IIA or IIIA therapy for 14 days then are crossed over to the alternate regimen for 14 days AS PER AMENDMENT 41798 After completion of therapy on Arm A or B patients continue therapy with indinavir alone for 7 days AS PER AMENDMENT 111698 The final 7 days of indinavir dosing has been eliminated for patients on Arm A Also per this amendment to ensure compliance Arm A patients rifabutin supply will be dispensed in containers fitted with an electronic monitoring cap device
Study Arm A is a multiple-dose 3-period sequential study in 18 evaluable HIV-infected indinavir-naive male and female volunteers AS PER AMENDMENT 111698 Arm A will be assessed in 18 evaluable HIV-seronegative patients Patients receive 3 different treatments consisting of 14 days of administration rifabutin alone Period IA indinavir plus rifabutin Period IIA and indinavir plus rifabutin Period IIIA Study Arm B is a multiple-dose 2-period sequential study in 10 evaluable HIV-infected male and female volunteers Patients receive 2 different treatments each consisting of 14 days of administration indinavir alone Period IB and indinavir plus rifabutin Period IIB Patients on both arms take each dose of their study medications with water AS PER AMENDMENT 8897 Patients treated on Arm A are randomized following Period IA therapy to Period IIA or IIIA therapy for 14 days then are crossed over to the alternate regimen for 14 days AS PER AMENDMENT 41798 After completion of therapy on Arm A or B patients continue therapy with indinavir alone for 7 days AS PER AMENDMENT 111698 The final 7 days of indinavir dosing has been eliminated for patients on Arm A Also per this amendment to ensure compliance Arm A patients rifabutin supply will be dispensed in containers fitted with an electronic monitoring cap device
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 |
|---|---|---|---|
| 11328 | REGISTRY | DAIDS ES | None |