Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474435
Status:
UNKNOWN
Last Update Posted:
2010-12-17
First Post:
2007-05-16
Brief Title:
Pharmacokinetics of EmtricitabineTenofovirEfavirenz in HIV-infected Patients With Tuberculosis
Sponsor:
African Poverty Related Infection Oriented Research Initiative
Organization:
African Poverty Related Infection Oriented Research Initiative
Study Overview
Official Title:
The Pharmacokinetics of Co-formulated EmtricitabineTenofovirEfavirenz in HIV-infected Patients With Smear-positive Pulmonary Tuberculosis in the Kilimanjaro Region Tanzania
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
RECRUITING
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:
PETE
Brief Summary:
In this pilot study the pharmacokinetics and safety of the antiretroviral combination of co-formulated emtricitabinetenofovirefavirenz will be studied in HIV-positive patients with pulmonary tuberculosis TB who are concomitantly treated with a standard rifampin-containing tuberculostatic regimen It is expected that this antiretroviral combination causes minimal drug interactions with the rifampin-containing anti-tuberculosis medication
Detailed Description:
The primary objectives of this pilot study in 30 patients are
1 To determine the effect of rifampin-containing tuberculostatic treatment on the pharmacokinetic profile of emtricitabinetenofovirefavirenz when co-formulated in one tablet in HIV-infected patients with smear-positive pulmonary tuberculosis in Tanzania
2 To determine the effect of the emtricitabinetenofovirefavirenz regimen on the pharmacokinetics of tuberculostatics in the same population
The secondary objectives are
1 To determine the safety of co-administration of emtricitabinetenofovirefavirenz with treatment for smear-positive pulmonary tuberculosis
2 To determine the short-term 24 weeks virological efficacy on HIV of an emtricitabinetenofovirefavirenz regimen in patients with smear-positive pulmonary tuberculosis
3 To determine the short-term bacteriological efficacy on smear-positive tuberculosis of the co-administration of a standard regimen for tuberculosis and an emtricitabinetenofovirefavirenz regimen
1 To determine the effect of rifampin-containing tuberculostatic treatment on the pharmacokinetic profile of emtricitabinetenofovirefavirenz when co-formulated in one tablet in HIV-infected patients with smear-positive pulmonary tuberculosis in Tanzania
2 To determine the effect of the emtricitabinetenofovirefavirenz regimen on the pharmacokinetics of tuberculostatics in the same population
The secondary objectives are
1 To determine the safety of co-administration of emtricitabinetenofovirefavirenz with treatment for smear-positive pulmonary tuberculosis
2 To determine the short-term 24 weeks virological efficacy on HIV of an emtricitabinetenofovirefavirenz regimen in patients with smear-positive pulmonary tuberculosis
3 To determine the short-term bacteriological efficacy on smear-positive tuberculosis of the co-administration of a standard regimen for tuberculosis and an emtricitabinetenofovirefavirenz regimen
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