A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients (SAPIT)
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ClinicalTrials.gov Identifier: NCT00398996 |
Recruitment Status
:
Completed
First Posted
: November 14, 2006
Last Update Posted
: March 24, 2011
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Tuberculosis | Drug: Early versus intermediate versus late initiation of ART | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 642 participants |
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 |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
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
|
- To measure the incidence of progression to AIDS defining illness or mortality [ Time Frame: 18 months ]
- A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms [ Time Frame: 18 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398996
South Africa | |
CAPRISA eThekwini Clinical Research Site | |
Durban, KwaZulu-Natal, South Africa, 4001 |
Principal Investigator: | Salim S Abdool karim, MBChB, PhD | CAPRISA, University of KwaZulu-Natal |
Additional Information:
Publications of Results:
Other Publications:
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 |
First Posted: | November 14, 2006 Key Record Dates |
Last Update Posted: | March 24, 2011 |
Last Verified: | March 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |