Page 15 - HIV/AIDS Guidelines

Introduction (Last updated January 10, 2011; last reviewed January 10, 2011)

Antiretroviral therapy (ART) for the treatment of human immunodeficiency virus (HIV) infection has
improved steadily since the advent of potent combination therapy in 1996. New drugs have been ap-
proved that offer new mechanisms of action, improvements in potency and activity even against mul-
tidrug-resistant viruses, dosing convenience, and tolerability.
The Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults
and Adolescents (the Panel) is a working group of the Office of AIDS Research Advisory Council
(OARAC). The primary goal of the Panel is to provide recommendations for HIV care practitioners
based on current knowledge of antiretroviral (ARV) drugs used to treat adults and adolescents with HIV
infection in the United States. The Panel reviews new evidence and updates recommendations when
needed. The primary areas of attention have included baseline assessment, treatment goals, indications
for initiation of ART, choice of the initial regimen in ART-naive patients, drugs or combinations to be
avoided, management of adverse effects and drug interactions, management of treatment failure, and
special ART-related considerations in specific patient populations.

These guidelines generally represent the state of knowledge regarding the use of ARV agents. However,
because the science evolves rapidly, the availability of new agents and new clinical data may change
therapeutic options and preferences. Information included in these guidelines may not be consistent with
approved labeling for the particular products or indications in question, and the terms “safe” and “effec-
tive” may not be synonymous with the Food and Drug Administration (FDA)-defined legal standards for
product approval. The guidelines are updated frequently by the Panel (current and archived versions of
the guidelines are available on the AIDSinfo Web site at http://www.aidsinfo.nih.gov). However, the
guidelines cannot always keep pace with the rapid evolution of new data in this field, and they cannot
provide guidance for all patients. Clinicians should exercise clinical judgment in management decisions
tailored to unique patient circumstances.

The Panel recognizes the importance of clinical research in generating evidence to address unanswered ques-
tions related to the optimal safety and efficacy of ART. The Panel encourages both the development of proto-
cols and patient participation in well-designed, Institutional Review Board (IRB)-approved clinical trials.

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents A-1

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