title: No differences in clinical outcomes with the addition of viral load testing to CD4 cell count monitoring among HIV infected participants receiving ART in rural Uganda: Long-term results from the Home Based AIDS Care Project.
abstract: BACKGROUND
  We compared clinical outcomes among HIV-infected participants receiving ART who were randomized to viral load (VL) and CD4 cell count monitoring in comparison to CD4 cell count monitoring alone in Tororo, Uganda.
  
  
  METHODS
  Beginning in May 2003, participants with CD4 cell counts <250 cells/μL or WHO stage 3 or 4 disease were randomized to clinical monitoring alone, clinical monitoring plus quarterly CD4 cell counts (CD4-only); or clinical monitoring, quarterly CD4 cell counts and quarterly VL testing (CD4-VL). In 2007, individuals in clinical monitoring arm were re-randomized to the other two arms and all participants were followed until March 31, 2009. We used Cox Proportional Hazard models to determine if study arm was independently associated with the development of opportunistic infections (OIs) or death.
  
  
  RESULTS
  We randomized 1211 participants to the three original study arms and 331 surviving participants in the clinical monitoring arm were re-randomized to the CD4-VL and CD4 only arms. At enrolment the median age was 38 years and the median CD4 cell count was 134 cells/μL. Over a median of 5.2 years of follow-up, 37 deaths and 35 new OIs occurred in the VL-CD4 arm patients, 39 deaths and 42 new OIs occurred in CD4-only patients. We did not observe an association between monitoring arm and new OIs or death (AHR =1.19 for CD4-only vs. CD4-VL; 95 % CI 0.82-1.73).
  
  
  CONCLUSIONS
  We found no differences in clinical outcomes associated with the addition of quarterly VL monitoring to quarterly CD4 cell count monitoring.
authors.affiliation: The AIDS Support Organization-TASO, Headquarters, Mulago Hospital Complex, P.O BOX 10443, Kampala, Uganda. stephenokoboi@yahoo.co.uk.
authors.forename: Stephen
authors.initials: S
authors.lastname: Okoboi
authors.affiliation: University of Alberta, Edmonton, Canada. pekwaru@gmail.com.
authors.forename: Paul John
authors.initials: PJ
authors.lastname: Ekwaru
authors.affiliation: University of Maryland School of Medicine, Baltimore, MD, USA. jcampbell@medicine.umaryland.edu.
authors.forename: James D
authors.initials: JD
authors.lastname: Campbell
authors.affiliation: The AIDS Support Organization-TASO, Headquarters, Mulago Hospital Complex, P.O BOX 10443, Kampala, Uganda. egessaa@tasouganda.org.
authors.forename: Aggrey
authors.initials: A
authors.lastname: Egessa
authors.affiliation: University of California, San Francisco, USA. rach@vtx.ch.
authors.forename: Racheal
authors.initials: R
authors.lastname: King
authors.affiliation: The AIDS Support Organization-TASO, Headquarters, Mulago Hospital Complex, P.O BOX 10443, Kampala, Uganda. bakandac@tasouganda.org.
authors.forename: Celestin
authors.initials: C
authors.lastname: Bakanda
authors.affiliation: Makerere University School of Public Health, Kampala, Uganda. 6emuba@gmail.com.
authors.forename: Emmy
authors.initials: E
authors.lastname: Muramuzi
authors.affiliation: Makerere University School of Public Health, Kampala, Uganda. fkaharuz@gmail.com.
authors.forename: Frank
authors.initials: F
authors.lastname: Kaharuza
authors.affiliation: Makerere University School of Public Health, Kampala, Uganda. malambas@gmail.com.
authors.forename: Samuel
authors.initials: S
authors.lastname: Malamba
authors.affiliation: BC Centre for Excellence in HIV/AIDS, Vancouver, Canada. dmoore@cfenet.ubc.ca.|University of British Columbia, Vancouver, Canada. dmoore@cfenet.ubc.ca.
authors.forename: David M
authors.initials: DM
authors.lastname: Moore
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy / Q000821:virology; D000328:Adult; D044966:Anti-Retroviral Agents / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count / Q000706:statistics & numerical data*; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014454:Uganda / Q000453:epidemiology; D019562:Viral Load / Q000706:statistics & numerical data*
chemical_list: D044966:Anti-Retroviral Agents
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