Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115609
Status:
COMPLETED
Last Update Posted:
2011-12-22
First Post:
2005-06-23
Brief Title:
Efficacy of Tenofovir-Emtricitabine and Efavirenz in HIV Infected Patients With Tuberculosis ANRS129
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Pilot Trial Evaluating Once Daily Triple Combination Antiretroviral Therapy With Tenofovir-Emtricitabine and Efavirenz in HIV-1 Infected Patients With Mycobacterium Tuberculosis Infection ANRS129 BKVIR
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Successful therapy of both tuberculosis and HIV disease share similar problems pill burden drug interaction adherence challenge and toxicity This study will test the efficacy and safety of a once daily antiretroviral regimen in HIV-tuberculosis coinfected patients
Detailed Description:
The proposed research consists of conducting a pilot trial BKVIR designed to answer the question of whether once daily tenofovir-emtricitabine-efavirenz triple-agent therapy is effective and well tolerated when it must be initiated within three months after initiation of a three-agent or four-agent tuberculostatic therapy in antiretroviral-naive HIV-infected patients As the proposed pilot trial comprises the initiation of antiretroviral therapy during the three months following the initiation of tuberculostatic therapy we propose to set up systematic continuous registration of HIV-infected patients with a diagnosis of tuberculosis in participating centers during the study period in order to evaluate their eligibility for inclusion in the pilot trial The initial declaration phase in the register in addition to facilitating inclusions in the pilot trial should also allow 1 a better understanding of the reasons for non-inclusion in the trial allowing the eligibility criteria to be adjusted if necessary during the trial and 2 to describe the antiretroviral therapies used during co-infection and their time of initiation in relation to tuberculostatic therapy
This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients The data collected will constitute a unique database on this issue not only in France but also internationally which will also be useful to optimize management strategies of these two diseases in developing countries
This research is expected to contribute to an updating of the treatment guidelines in the context of tuberculosis in HIV-infected patients The data collected will constitute a unique database on this issue not only in France but also internationally which will also be useful to optimize management strategies of these two diseases in developing countries
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 |
|---|---|---|---|
| ANRS129 BKVIR | None | None | None |