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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Health Authority: South Africa: Medicines Control Council

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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Infection
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014