Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091936
Status:
COMPLETED
Last Update Posted:
2010-03-29
First Post:
2004-09-20
Brief Title:
Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Implementing Anti-Retroviral Therapy in Resource-Constrained Settings A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in Subjects Co-Infected With Tuberculosis and HIV
Status:
COMPLETED
Status Verified Date:
2007-01
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:
Tuberculosis TB a bacterial infection common in HIV infected people is a major problem in developing countries The purpose of this study is to test the effectiveness of a combined treatment strategy using directly observed therapy DOT for HIV infected patients with TB Participants will be recruited from resource-poor communities in Durban South Africa
Detailed Description:
TB is the most common serious infectious complication associated with HIV in sub-Saharan Africa and is also the most common cause of death among HIV infected patients in developing countries Furthermore TB in an HIV infected person accelerates the progression of HIV disease and hastens death This study will evaluate a combined TB and antiretroviral treatment ART strategy utilizing DOT in HIV infected people coinfected with TB This study will compare two treatment strategies TB and HIV medications given concurrently integrated arm and TB treatment completed first followed by HIV treatment sequential arm
This study has two parts The entire study will last 24 months after participants have been randomly assigned to one of two arms Arm 1 integrated arm participants will receive didanosine ddI efavirenz EFV and lamivudine 3TC once daily concurrent with standard TB therapy ART and TB medications will be provided through DOT on weekdays participants will take their medications without DOT on weekends Arm 1 participants will also attend four 15- to 20-minute sessions of an adherence study program at study start Week 2 Month 2 and 1 to 3 weeks prior to the end of TB therapy
Arm 2 sequential arm participants will first receive DOT-provided TB treatment alone After completion of TB treatment participants will receive ddI EFV and 3TC once daily without DOT
Study visits in the first part of the study will occur at screening study start Weeks 1 2 and 3 and every month until the end of the first part of the study at Month 12 Study visits will include blood collection medical and medication history assessment a physical exam and pill counts Patients will be asked to complete an adherence questionnaire at every study visit and a sexual behavior survey and quality of life questionnaire at study start and Month 6
This study has two parts The entire study will last 24 months after participants have been randomly assigned to one of two arms Arm 1 integrated arm participants will receive didanosine ddI efavirenz EFV and lamivudine 3TC once daily concurrent with standard TB therapy ART and TB medications will be provided through DOT on weekdays participants will take their medications without DOT on weekends Arm 1 participants will also attend four 15- to 20-minute sessions of an adherence study program at study start Week 2 Month 2 and 1 to 3 weeks prior to the end of TB therapy
Arm 2 sequential arm participants will first receive DOT-provided TB treatment alone After completion of TB treatment participants will receive ddI EFV and 3TC once daily without DOT
Study visits in the first part of the study will occur at screening study start Weeks 1 2 and 3 and every month until the end of the first part of the study at Month 12 Study visits will include blood collection medical and medication history assessment a physical exam and pill counts Patients will be asked to complete an adherence questionnaire at every study visit and a sexual behavior survey and quality of life questionnaire at study start and Month 6
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 |
|---|---|---|---|
| CIPRA | None | None | None |
| CAPRISA 001 | None | None | None |
| START | None | None | None |