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Modified Directly Observed Antiretroviral Therapy Compared With Self-administered Therapy in Treatment-Naïve HIV-1–Infected PatientsA Randomized Trial
Robert Gross, MD, MSCE;
Camlin Tierney, PhD;
Adriana Andrade, MD, MPH;
Christina Lalama, MS;
Susan Rosenkranz, PhD;
Susan H. Eshleman, MD, PhD;
Timothy Flanigan, MD;
Jorge Santana, MD;
Nadim Salomon, MD;
Ronald Reisler, MD;
Ilene Wiggins, RN;
Evelyn Hogg, BA;
Charles Flexner, MD;
Donna Mildvan, MD; for the AIDS Clinical Trials Group A5073 Study Team
Arch Intern Med. 2009;169(13):1224-1232. doi:10.1001/archinternmed.2009.172
Background Success of antiretroviral therapy depends on high rates of adherence, but few interventions are effective. Our objective was to determine if modified directly observed therapy (mDOT) improves initial antiretroviral success.
Methods In an open-label, randomized trial comparing mDOT (Monday-Friday for 24 weeks) and self-administered therapy with lopinavir/ritonavir soft gel capsules (800 mg/200 mg), emtricitabine (200 mg), and either extended-release stavudine (100 mg) or tenofovir (300 mg), all taken once daily, 82 participants received mDOT and 161, self-administered therapy. Participant eligibility included a plasma human immunodeficiency virus RNA level higher than 2000 copies/mL and being naïve to antiretroviral therapy. A total of 243 participants were predominantly male (79%) (median age, 38 years), with 84 Latinos (35%), 74 non-Latino blacks (30%), and 79 non-Latino whites (33%). The study was conducted at 23 AIDS Clinical Trials Group (ACTG) sites in the United States and 1 site in South Africa between October 2002 and January 2006. The primary outcome was virologic success at week 24 and secondary outcomes were virologic success, clinical progression, and adherence at week 48.
Results Over 24 weeks, mDOT had greater virologic success (0.91; 95% confidence interval [CI], 0.81 to 0.95) than self-administered therapy (0.84; 95% CI, 0.77 to 0.89), but the difference (0.07; lower bound 95% CI, –0.01) did not reach the prespecified threshold of 0.075. Over 48 weeks, virologic success was not significantly different between mDOT (0.72; 95% CI, 0.61 to 0.81) and self-administered therapy (0.78; 95% CI, 0.70 to 0.84) (difference, –0.06; 95% CI, –0.18 to 0.07 [P = .19]).
Conclusions The potential benefit of mDOT was marginal and not sustained after discontinuation. Modified DOT should not be incorporated routinely for care of treatment-naïve human immunodeficiency virus type 1–infected patients.
Trial Registration clinicaltrials.gov Identifier: NCT00036452
Author Affiliations: Department of Medicine (Infectious Diseases), Center for Clinical Epidemiology and Biostatistics, and Center for Education and Research in Therapeutics, University of Pennsylvania School of Medicine, Philadelphia (Dr Gross); Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts (Drs Tierney and Rosenkranz and Ms Lalama); Departments of Medicine (Drs Andrade and Flexner and Ms Wiggins) and Pathology (Dr Eshleman), Johns Hopkins University School of Medicine, Baltimore, Maryland; Department of Medicine, Brown Medical School, The Miriam Hospital, Providence, Rhode Island (Dr Flanigan); Department of Medicine, University of Puerto Rico, San Juan (Dr Santana); Department of Medicine (Infectious Diseases), Beth Israel Medical Center, New York, New York (Drs Salomon and Mildvan); Department of Medicine (Infectious Diseases), University of Maryland School of Medicine, Baltimore (Dr Reisler); and Social & Scientific Systems Inc, Silver Spring, Maryland (Ms Hogg).
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RELATED LETTERS
DAART for Human Immunodeficiency Virus–Infected Patients: Studying Subjects Not at Risk for Nonadherence and Use of Untested Interventions
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DAART for Human Immunodeficiency Virus–Infected Patients: Studying Subjects Not at Risk for Nonadherence and Use of Untested Interventions—Reply
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