Directly administered antiretroviral therapy DAART in conjunction with methadone is associated with

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Directly administered antiretroviral therapy
(DAART) in conjunction with methadone is
associated with improved HIV treatment outcomes
in HIV-infected injection drug users (IDUs)

• Gregory M. Lucasa, B. Anna Mullena, Paul J.
  Weidleb, Shannon Haderb, Richard D. Moorea
• Johns Hopkins University, Baltimore MDa,
• and
• Centers for Disease Control and Prevention,
  Atlanta, GAb

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Background

• IDU is a major HIV transmission factor and is
  associated with lower adherence with HAART and
  poorer treatment outcomes
• Objective to assess the feasibility and
  potential efficacy of DAART in conjunction with
  methadone maintenance therapy

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Methods DAART study

• Conducted at three methadone clinics in Baltimore
• Original JHU site in April 2001
• Two additional pilot sites added in September
  2003
• Follow-up censored March 2005
• ART dosed in the morning by medical assistant in
  private room near methadone dispensing window
• Pre-packaged ART given to participants to
  self-administer on nights and weekends

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Methods DAART enrollment criteria and selection
of non-randomized comparison patients
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Methods comparisons between DAART and cohort
control patients
IDU()meth (N91)
Cohort comparison patients (N1055)
IDU(-)meth (N302)
Comparisons
Non-IDU (N662)
DAART (N88)
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Methods statistical analysis

• Outcomes
• HIV RNA lt 400 c/ml ITT(MF)
• Change in CD4 cell count from baseline
  ITT(LOCF)
• Chi-square and Wilcoxon rank sum for discrete and
  continuous variables, respectively
• Multivariate logistic regression of factors
  associated with viral suppression at 6 months

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Baseline characteristics
Plt0.05 compared to DAART
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Viral suppression by 6 and 12 months
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Change in CD4 cell count from baseline
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Multivariate model of factors associated with
achieving HIV RNA lt 400 c/ml by 6 months
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Conclusions

• DAART participants had higher rates of viral
  suppression and greater increases in CD4 cell
  counts than the cohort comparison groups
• After adjustment in a multivariate model, DAART
  remained significantly associated with viral
  suppression at 6 months compared to the other
  groups
• This study was a non-randomized cohort
  comparison, selection and other biases cannot be
  excluded
• Given the importance of IDU in the HIV epidemic
  worldwide, additional studies of DAART combined
  with pharmacologic replacement therapy for opioid
  dependence are needed

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Acknowledgments

• Johns Hopkins
• Gregory Lucas
• Richard Moore
• B. Anna Mullen
• Tracey Whoolery
• Mary McCaul
• Jeanne Keruly
• CDC
• Paul Weidle
• Shannon Hader

• New Hope Clinic
• Sharon Pugh
• Carrie Little
• Jim Chambers
• Day Break Clinic
• Helen Norman
• Sheldon Glass
• Herman Jones
• Study Participants