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

BMC Infectious Diseases

Ronald T Mitsuyasu¹  Vishnu Sreenivas²  Meera Ekka⁴  Sanjai Ranjan⁴  JC Samantaray³  Surendra K Sharma⁴  Narendra Kumar⁴  Hafiz Ahmad³  Nipam Shah⁴  Gurjeet Singh⁴  Rahul C Shekhar⁴  Sanjeev Sinha⁴ 

[1] UCLA Center for Clinical AIDS Research & Education, University of California, Los Angeles, USA;Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India;Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India;Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India

关键词: Tuberculosis;    HIV;    Delayed;    Early;    Antiretroviral;   

Others  :  1175323
DOI  :  10.1186/1471-2334-12-168

 received in 2011-12-01, accepted in 2012-07-24,  发布年份 2012

【 摘 要 】

Background

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.

Methods

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.

Findings

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.

Interpretation

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

Trial registration

CTRI/2011/12/002260

【 授权许可】

   
2012 Sinha et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

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