Clinical Trials

MainTitle

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
Centre for the AIDS Programme of Research in South Africa


Information provided by (Responsible Party)
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
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections
Tuberculosis

Drug : Early versus intermediate versus late initiation of ART
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

Further study details as provided by Centre for the AIDS Programme of Research in South Africa:

Primary Outcome Measures

  • To measure the incidence of progression to AIDS defining illness or mortality [ Time Frame: 18 months ]
Secondary Outcome Measures:
  • A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms [ Time Frame: 18 months ]

Enrollment: 642
Study Start Date: June 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: 1 - Early integrated-therapy group
antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment
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: 2 - Late integrated-therapy group
antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment
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: 3 - Sequential-therapy group
Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398996

Locations

South Africa
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, South Africa, 4001

Sponsors and Collaborators

Centre for the AIDS Programme of Research in South Africa

Investigators

Principal Investigator: Salim S Abdool karim, MBChB, PhD CAPRISA, University of KwaZulu-Natal
More Information

More Information

Additional Information:

Centre for the AIDS Programme of Research in South Africa's website

Responsible Party: Director: Prof Salim S Abdool Karim, CAPRISA  
ClinicalTrials.gov Identifier: NCT00398996   History of Changes  
Other Study ID Numbers: CAPRISA 003  
Study First Received: November 7, 2006  
Last Updated: March 23, 2011  

Keywords provided by Centre for the AIDS Programme of Research in South Africa:

antiretroviral therapy
HIV
Opportunistic infections
CD4
Viral load
TB/HIV co infection
Treatment Naive

Additional relevant MeSH terms:
Infection
HIV Infections
Tuberculosis

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.