A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients
SAPIT
Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients
1 other identifier
interventional
642
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
Started Jun 2005
Typical duration for phase_3 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 7, 2006
CompletedFirst Posted
Study publicly available on registry
November 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedMarch 24, 2011
March 1, 2011
5.1 years
November 7, 2006
March 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the incidence of progression to AIDS defining illness or mortality
18 months
Secondary Outcomes (1)
A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms
18 months
Study Arms (3)
1 - Early integrated-therapy group
ACTIVE COMPARATORantiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment
2 - Late integrated-therapy group
ACTIVE COMPARATORantiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment
3 - Sequential-therapy group
ACTIVE COMPARATORAntiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, 4001, South Africa
Related Publications (4)
Abdool-Karim SS, Abdool-Karim Q, Friedland G, Lalloo U, El-Sadr WM; START project. Implementing antiretroviral therapy in resource-constrained settings: opportunities and challenges in integrating HIV and tuberculosis care. AIDS. 2004 Apr 30;18(7):975-9. doi: 10.1097/00002030-200404300-00004. No abstract available.
PMID: 15096799BACKGROUNDAbdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.
PMID: 20181971RESULTNaidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004.
PMID: 22944873DERIVEDAbdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.
PMID: 22010915DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salim S Abdool karim, MBChB, PhD
CAPRISA, University of KwaZulu-Natal
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
November 7, 2006
First Posted
November 14, 2006
Study Start
June 1, 2005
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
March 24, 2011
Record last verified: 2011-03