title: Early versus delayed initiation of antiretroviral therapy for Indian HIV-Infected individuals with tuberculosis on antituberculosis treatment.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Early initiation of HAART for patients with HIV and TB significantly decreases incidence of HIV disease progression and has good tolerability.
  
  
  BACKGROUND
  CTRI/2011/12/002260.
authors: Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India. drsanjeevsinha2002@yahoo.com
authors: Sanjeev
authors: S
authors: Sinha
authors: Rahul C
authors: RC
authors: Shekhar
authors: Gurjeet
authors: G
authors: Singh
authors: Nipam
authors: N
authors: Shah
authors: Hafiz
authors: H
authors: Ahmad
authors: Narendra
authors: N
authors: Kumar
authors: Surendra K
authors: SK
authors: Sharma
authors: J C
authors: JC
authors: Samantaray
authors: Sanjai
authors: S
authors: Ranjan
authors: Meera
authors: M
authors: Ekka
authors: Vishnu
authors: V
authors: Sreenivas
authors: Ronald T
authors: RT
authors: Mitsuyasu
mesh_terms: D000328:Adult; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D000995:Antitubercular Agents / Q000008:administration & dosage*; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D015994:Incidence; D007194:India; D008297:Male; D016019:Survival Analysis; D013997:Time Factors; D017211:Treatment Failure; D014376:Tuberculosis / Q000150:complications* / Q000188:drug therapy* / Q000401:mortality
chemical_list: D044966:Anti-Retroviral Agents; D000995:Antitubercular Agents