Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naive HIV-1-infected patients: a randomized trial.

TitleModified directly observed antiretroviral therapy compared with self-administered therapy in treatment-naive HIV-1-infected patients: a randomized trial.
Publication TypeJournal Article
Year of Publication2009
AuthorsGross R, Tierney C, Andrade A, Lalama C, Rosenkranz S, Eshleman SH, Flanigan T, Santana J, Salomon N, Reisler R, Wiggins I, Hogg E, Flexner C, Mildvan D
Corporate AuthorsAIDS Clinical Trials Group A5073 Study Team
JournalArch Intern Med
Volume169
Issue13
Pagination1224-32
Date Published2009 Jul 13
ISSN1538-3679
KeywordsAdenine, Administration, Oral, Adolescent, Adult, Aged, Anti-HIV Agents, Deoxycytidine, Dose-Response Relationship, Drug, Emtricitabine, Female, Follow-Up Studies, HIV Infections, HIV-1, Humans, Lopinavir, Male, Middle Aged, Organophosphonates, Pyrimidinones, Retrospective Studies, RNA, Viral, Stavudine, Tenofovir, Treatment Outcome, Young Adult
Abstract

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.

DOI10.1001/archinternmed.2009.172
Alternate JournalArch. Intern. Med.
PubMed ID19597072
PubMed Central IDPMC2771688
Grant ListK08 MH001584 / MH / NIMH NIH HHS / United States
K08 MH001584-01A2 / MH / NIMH NIH HHS / United States
K08 MH001584-02 / MH / NIMH NIH HHS / United States
K08 MH001584-03 / MH / NIMH NIH HHS / United States
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