Page 16 - HIV/AIDS Guidelines

Guidelines Development Process

Table 1. Outline of the Guidelines Development Process

Topic Comment

Goal of the Provide guidance to HIV care practitioners on the optimal use of ARV agents for the treatment of HIV
guidelines infection in adults and adolescents in the United States.

Panel members The Panel is composed of more than 30 voting members who have expertise in HIV care and research.
The U.S. government representatives include at least 1 representative from each of the following DHHS
agencies: Centers for Disease Control and Prevention (CDC), FDA, Health Resource Services
Administration (HRSA), and National Institutes of Health (NIH). These members are appointed by their
respective agencies. Approximately 2/3 of the Panel members are nongovernmental scientific members.
There are 4–5 community members with knowledge in HIV treatment and care. Members who do not
represent U.S. government agencies are selected after an open announcement to call for nominations.
Each member serves on the Panel for a 4-year term, with an option to be reappointed for an additional
term. A list of the current members can be found on Page vii of this document.
Financial All members of the Panel submit a written financial disclosure annually reporting any association with
disclosures manufacturers of ARV drugs or diagnostics used for management of HIV infections. A list of the latest
disclosures is available.
Users of the HIV treatment providers
guidelines
Developer Panel on Antiretroviral Guidelines for Adults and Adolescents—a working group of OARAC

Funding source Office of AIDS Research, NIH
Evidence The recommendations in the guidelines are generally based on studies published in peer-reviewed
collection journals. On some occasions, particularly when new information may affect patient safety, unpublished
data presented at major conferences or prepared by the FDA and/or manufacturers as warnings to the
public may be used as evidence to revise the guidelines.

Recommendation As described in Table 2.
grading
Method of Each section of the guidelines is assigned to a working group of Panel members with expertise in the area
synthesizing data of interest. The members of the working group synthesize the available data and propose
recommendations to the Panel. All proposals are discussed at monthly teleconferences and then voted on
by the Panel before being endorsed as official recommendations.
Other guidelines These guidelines focus on treatment for HIV-infected adults and adolescents. Separate guidelines
outline the use of ART for other populations, such as pregnant women and children. These guidelines
are also available on the AIDSinfo Web site (http://www.aidsinfo.nih.gov). There is a brief discussion of
the management of women of reproductive age and pregnant women in this document. For a more
detailed and up-to-date discussion on this group of women and other special populations, the Panel
defers to the designated expertise offered by panels that have developed those guidelines.
Update plan The Panel meets monthly by teleconference to review data that may warrant modification of the
guidelines. Updates may be prompted by new drug approvals (or new indications, dosing formulations,
or frequency), new significant safety or efficacy data, or other information that may have a significant
impact on the clinical care of patients. For cases in which significant new data become available that
may affect patient safety, a warning announcement with the Panel’s recommendations may be made on
the AIDSinfo Web site until appropriate changes can be made in the guidelines document. Updated
guidelines are available on the AIDSinfo Web site (http://www.aidsinfo.nih.gov).
Public After release of an update on the AIDSinfo Web site, the public is given a 2-week period to submit
comments comments to the Panel. These comments are reviewed, and a determination is made as to whether
revisions are indicated. The public may also submit comments to the Panel at any time at
contactus@aidsinfo.nih.gov.

Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents A-2

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