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Directly Administered Antiretroviral Therapy for HIV-Infected Drug Users Does Not Have an Impact on Antiretroviral Resistance: Results From a Randomized Controlled Trial

Maru, Duncan Smith-Rohrberg MPhil; Kozal, Michael J MD; Bruce, R Douglas MD, MA; Springer, Sandra A MD; Altice, Frederick L MD

JAIDS Journal of Acquired Immune Deficiency Syndromes: December 15th, 2007 - Volume 46 - Issue 5 - p 555-563
doi: 10.1097/QAI.0b013e318158c0bd
Clinical Science

Background: Directly administered antiretroviral therapy (DAART) is an effective intervention that improves clinical outcomes among HIV-infected drug users. Its effects on antiretroviral drug resistance, however, are unknown.

Methods: We conducted a community-based, prospective, randomized controlled trial of DAART compared with self-administered therapy (SAT). We performed a modified intention-to-treat analysis among 115 subjects who provided serum samples for HIV genotypic resistance testing at baseline and at follow-up. The main outcomes measures included total genotypic sensitivity score, future drug options, number of new drug resistance mutations (DRMs), and number of new major International AIDS Society (IAS) mutations.

Results: The adjusted probability of developing at least 1 new DRM did not differ between the 2 arms (SAT: 0.41 per person-year [PPY], DAART: 0.49 PPY; adjusted relative risk [RR] = 1.04; P = 0.90), nor did the number of new mutations (SAT: 0.76 PPY, DAART: 0.83 PPY; adjusted RR = 0.99; P = 0.99) or the probability of developing new major IAS new drug mutations (SAT: 0.30 PPY, DAART: 0.33 PPY; adjusted RR = 1.12; P = 0.78). On measures of GSS and FDO, the 2 arms also did not differ.

Conclusion: In this trial, DAART provided on-treatment virologic benefit for HIV-infected drug users without affecting the rate of development of antiretroviral medication resistance.

From the Yale University AIDS Program, Yale University School of Medicine, New Haven, CT.

Received for publication May 21, 2007; accepted August 17, 2007.

The National Institutes on Drug Abuse (R01 DA13805) funded this study and provided career development awards for F. L. Altice (K24 DA 0170720), S. A. Springer (K23 DA 019381), and R. D. Bruce (K23 DA 022143). D. Smith-Rohrberg Maru receives funding from the National Institutes of Health Medical Science Training Program (GM07205).

The funding sources played no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Correspondence to: Frederick L. Altice, MD, Yale University AIDS Program, 135 College Street, Suite 323 New Haven, CT 06510-2283 (e-mail: raltice@aol.com).

© 2007 Lippincott Williams & Wilkins, Inc.