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A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients (SAPIT)

This study has been completed.
Sponsor:
Information provided by:
Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier:
NCT00398996
First received: November 7, 2006
Last updated: March 23, 2011
Last verified: March 2011

November 7, 2006
March 23, 2011
June 2005
July 2010   (final data collection date for primary outcome measure)
To measure the incidence of progression to AIDS defining illness or mortality [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • To determine the optimal time to start ART in patients on TB treatment
  • comparing clinical status (CD4 count, viral load, mortality rates and Opportunistic Infections) at 18 months
Complete list of historical versions of study NCT00398996 on ClinicalTrials.gov Archive Site
A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients
Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB 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 TB/HIV 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
Drug: Early versus intermediate versus late initiation of ART
Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed
  • Active Comparator: 1 - Early integrated-therapy group
    antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment
    Intervention: Drug: Early versus intermediate versus late initiation of ART
  • Active Comparator: 2 - Late integrated-therapy group
    antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment
    Intervention: Drug: Early versus intermediate versus late initiation of ART
  • Active Comparator: 3 - Sequential-therapy group
    Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment
    Intervention: Drug: Early versus intermediate versus late initiation of ART

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
642
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV infected patients co-infected with TB
  • Receiving any one of the standard anti-TB therapy regimens
  • All patients must agree to use contraception since they will be on efavirenz.

Exclusion Criteria:

  • Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT00398996
CAPRISA 003
Yes
Director: Prof Salim S Abdool Karim, CAPRISA
Centre for the AIDS Programme of Research in South Africa
Not Provided
Principal Investigator: Salim S Abdool karim, MBChB, PhD CAPRISA, University of KwaZulu-Natal
Centre for the AIDS Programme of Research in South Africa
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP