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Early versus delayed initiation of antiretroviral therapy for Indian HIV-Infected individuals with tuberculosis on antituberculosis treatment

Sanjeev Sinha1*, Rahul C Shekhar1, Gurjeet Singh1, Nipam Shah1, Hafiz Ahmad2, Narendra Kumar1, Surendra K Sharma1, JC Samantaray2, Sanjai Ranjan1, Meera Ekka1, Vishnu Sreenivas3 and Ronald T Mitsuyasu4

Author Affiliations

1 Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India

2 Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India

3 Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India

4 UCLA Center for Clinical AIDS Research & Education, University of California, Los Angeles, USA

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BMC Infectious Diseases 2012, 12:168  doi:10.1186/1471-2334-12-168

Published: 31 July 2012



For antiretroviral therapy (ART) naive human immunodeficiency virus (HIV) infected adults suffering from tuberculosis (TB), there is uncertainty about the optimal time to initiate highly active antiretroviral therapy (HAART) after starting antituberculosis treatment (ATT), in order to minimize mortality, HIV disease progression, and adverse events.


In a randomized, open label trial at All India Institute of Medical Sciences, New Delhi, India, eligible HIV positive individuals with a diagnosis of TB were randomly assigned to receive HAART after 2-4 or 8-12 weeks of starting ATT, and were followed for 12 months after HAART initiation. Participants received directly observed therapy short course (DOTS) for TB, and an antiretroviral regimen comprising stavudine or zidovudine, lamivudine, and efavirenz. Primary end points were death from any cause, and progression of HIV disease marked by failure of ART.


A total of 150 patients with HIV and TB were initiated on HAART: 88 received it after 2-4 weeks (early ART) and 62 after 8-12 weeks (delayed ART) of starting ATT. There was no significant difference in mortality between the groups after the introduction of HAART. However, incidence of ART failure was 31% in delayed versus 16% in early ART arm (p = 0.045). Kaplan Meier disease progression free survival at 12 months was 79% for early versus 64% for the delayed ART arm (p = 0.05). Rates of adverse events were similar.


Early initiation of HAART for patients with HIV and TB significantly decreases incidence of HIV disease progression and has good tolerability.

Trial registration


Antiretroviral; Early; Delayed; HIV; Tuberculosis