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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Early integrated-therapy group | Active Comparator | antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment |
|
| 2 - Late integrated-therapy group | Active Comparator | antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment |
|
| 3 - Sequential-therapy group | Active Comparator | Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early versus intermediate versus late initiation of ART | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the incidence of progression to AIDS defining illness or mortality | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salim S Abdool karim, MBChB, PhD | CAPRISA, University of KwaZulu-Natal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAPRISA eThekwini Clinical Research Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15096799 | Background | 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. | |
| 20181971 | Result |
| Label | URL |
|---|---|
| Centre for the AIDS Programme of Research in South Africa's website | View source |
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| Abdool 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. |
| 22944873 | Derived | Naidoo 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. |
| 22010915 | Derived | Abdool 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014376 | Tuberculosis |
| D009894 | Opportunistic Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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