Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398996
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
2006-11-07
Brief Title:
A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy ART Initiation in HIVTuberculosis TB Co-infected Patients
Sponsor:
Centre for the AIDS Programme of Research in South Africa
Organization:
Centre for the AIDS Programme of Research in South Africa
Study Overview
Official Title:
Study to Compare Three Existing Starting Points of ART Initiation in HIVTB Co-infected Patients
Status:
COMPLETED
Status Verified Date:
2011-03
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:
SAPIT
Brief Summary:
This is a randomized open-label study comparing three existing treatment strategies of ART initiation in HIVTB co-infected patients
Group 1 early initiation of ART with TB treatment Group 2 initiation of ART upon completion of the intensive phase of TB treatment Group 3 initiation of ART upon completion of the continuation phase of TB treatment
Approximately 700 men and women 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled Eligible TBHIV co-infected patients will be offered antiretroviral therapy ART starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy ART in patients on tuberculosis TB treatment by comparing clinical status CD4 cell count viral load opportunistic infections
Group 1 early initiation of ART with TB treatment Group 2 initiation of ART upon completion of the intensive phase of TB treatment Group 3 initiation of ART upon completion of the continuation phase of TB treatment
Approximately 700 men and women 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled Eligible TBHIV co-infected patients will be offered antiretroviral therapy ART starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy ART in patients on tuberculosis TB treatment by comparing clinical status CD4 cell count viral load opportunistic infections
Detailed Description:
None
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