The early years of the combination antiretroviral therapy (ART) era have brought about dramatic reductions in the morbidity and mortality associated with HIV infection in industrialized countries. Yet, the critical importance of adherence in optimizing treatment outcomes quickly became evident. My prior work has shown that injection drug users (IDUs) underutilize ART, and are at high risk for inadequate adherence and poorer treatment outcomes when therapy is used. Tuberculosis treatment with directly observed therapy (DOT) has proven remarkably effective in addressing issues currently being confronted in HIV management - promoting adherence, achieving clinical success, and avoiding drug resistance. Methadone maintenance is an effective treatment for opiate addiction and provides a feasible setting in which directly administered antiretroviral therapy (DAART) may be provided to HIV-infected patients. I propose to conduct a prospective clinical study to determine the effectiveness of DAART provided in a methadone maintenance clinic. Clinical outcomes will be compared in DAART participants and matched participants in the Johns Hopkins HIV Cohort Study. My hypothesis is that DAART will be effective in a methadone treatment center and will be associated with improved HIV treatment outcomes compared to standard care.
The specific aims of this project are to 1) assess 1-year retention in DAART and associated factors, 2) assess the temporal trend of adherence in DAART and its association with viral suppression, 3) compare virologic and immunologic responses to therapy in DAART participants and matched patients receiving standard care, and 4) compare the incidence of opportunistic diseases and death in DAART participants and matched patients receiving standard care. This proposal builds directly on my prior work and lays the foundation for a randomized, multi-site trial of the DAART strategy. My career development plan is based on the Graduate Training Program in Clinical Investigation, which includes comprehensive coursework at the Johns Hopkins School of Public Health, structured mentoring, and guidance from a thesis committee. My career plan and research proposal are consistent with my long-term goals of becoming an effective independent investigator, and optimizing treatment outcomes in HIV-infected IDUs.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
1K23DA015616-01
Application #
6553829
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Comolli, Jean C
Project Start
2002-08-10
Project End
2007-06-30
Budget Start
2002-08-10
Budget End
2003-06-30
Support Year
1
Fiscal Year
2002
Total Cost
$151,357
Indirect Cost
Name
Johns Hopkins University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
045911138
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Lucas, Gregory M; Mullen, Bernadette Anna; Galai, Noya et al. (2013) Directly administered antiretroviral therapy for HIV-infected individuals in opioid treatment programs: results from a randomized clinical trial. PLoS One 8:e68286
Mullen, Bernadette Anna; Cook, Katie; Moore, Richard D et al. (2011) Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs. BMC Infect Dis 11:45
Lucas, Gregory M; Chaudhry, Amina; Hsu, Jeffrey et al. (2010) Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial. Ann Intern Med 152:704-11
Parkhie, Shyam M; Fine, Derek M; Lucas, Gregory M et al. (2010) Characteristics of patients with HIV and biopsy-proven acute interstitial nephritis. Clin J Am Soc Nephrol 5:798-804
Yanik, Elizabeth L; Lucas, Gregory M; Vlahov, David et al. (2010) HIV and proteinuria in an injection drug user population. Clin J Am Soc Nephrol 5:1836-43
George, Elizabeth; Lucas, Gregory M; Nadkarni, Girish N et al. (2010) Kidney function and the risk of cardiovascular events in HIV-1-infected patients. AIDS 24:387-94
Solomon, Sunil S; Desai, Monica; Srikrishnan, A K et al. (2010) The profile of injection drug users in Chennai, India: identification of risk behaviours and implications for interventions. Subst Use Misuse 45:354-67
Lucas, Gregory M; Clarke, William; Kagaayi, Joseph et al. (2010) Decreased kidney function in a community-based cohort of HIV-Infected and HIV-negative individuals in Rakai, Uganda. J Acquir Immune Defic Syndr 55:491-4
Kavasery, Ravi; Galai, Noya; Astemborski, Jacquie et al. (2009) Nonstructured treatment interruptions among injection drug users in Baltimore, MD. J Acquir Immune Defic Syndr 50:360-6
Tabatabai, Sayed; Sperati, C John; Atta, Mohamed G et al. (2009) Predictors of complication after percutaneous ultrasound-guided kidney biopsy in HIV-infected individuals: possible role of hepatitis C and HIV co-infection. Clin J Am Soc Nephrol 4:1766-73

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