Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108862
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2005-04-19
Brief Title:
Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis
Sponsor:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Organization:
Advancing Clinical Therapeutics Globally for HIVAIDS and Other Infections
Study Overview
Official Title:
A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease-Free Survival in HIV-Infected Persons Treated for Tuberculosis With CD4 Less Than 250 Cellsmm3
Status:
COMPLETED
Status Verified Date:
2018-09
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:
STRIDE
Brief Summary:
The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis TB
Study hypothesis Immediate antiretroviral therapy ART initiated after approximately 2 weeks of TB treatment will reduce the frequency of other AIDS-defining illnesses and death in HIV-infected participants being treated for TB by at least 40 at week 48 when compared to deferred ART initiated at after 8-12 weeks of TB treatment
Study hypothesis Immediate antiretroviral therapy ART initiated after approximately 2 weeks of TB treatment will reduce the frequency of other AIDS-defining illnesses and death in HIV-infected participants being treated for TB by at least 40 at week 48 when compared to deferred ART initiated at after 8-12 weeks of TB treatment
Detailed Description:
Tuberculosis TB is the most important co-infection in the HIV epidemic the bi-directional relationship between the two diseases is well established HIV increases the risk for TB acquisition reactivation and reinfection and reduces survival compared to patients with TB alone In individuals with HIV TB infection results in reduced survival increased risk for opportunistic infections and elevations in HIV replication Improving the outcome of HIV-infected individuals who develop TB is of high importance Initiating antiretroviral therapy ART shortly after initiating TB treatment may improve outcomes in individuals co-infected with HIV and TB However data to support this suggestion were limited before this study began This study will determine the most appropriate time to initiate ART in HIV-infected individuals who recently initiated treatment for TB
This study lasted 48 weeks and comprised two steps At study entry participants underwent clinical assessment drug adherence training and blood collection In Step 1 participants were randomly assigned to one of two arms Participants in Arm A initiated ART after approximately 2 weeks of TB treatment Participants in Arm B deferred ART until after 8 to 12 weeks of TB treatment In Step 2 Arm B participants initiated ART Arm A participants did not enter Step 2 ART consisted of efavirenz EFV and emtricitabine FTCtenofovir disoproxil fumarate TDF FTC and TDF could be given as individual agents Drug substitutions could be made for participants who could not tolerate the specified regimen Blood collection and clinical assessments occurred at weeks 4 8 12 16 24 32 40 and 48
This study lasted 48 weeks and comprised two steps At study entry participants underwent clinical assessment drug adherence training and blood collection In Step 1 participants were randomly assigned to one of two arms Participants in Arm A initiated ART after approximately 2 weeks of TB treatment Participants in Arm B deferred ART until after 8 to 12 weeks of TB treatment In Step 2 Arm B participants initiated ART Arm A participants did not enter Step 2 ART consisted of efavirenz EFV and emtricitabine FTCtenofovir disoproxil fumarate TDF FTC and TDF could be given as individual agents Drug substitutions could be made for participants who could not tolerate the specified regimen Blood collection and clinical assessments occurred at weeks 4 8 12 16 24 32 40 and 48
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 |
|---|---|---|---|
| ACTG A5221 | OTHER | AIDS Clinical Trials Group | httpsreporternihgovquickSearch1U01AI068636 |
| 1U01AI068636 | NIH | None | None |