January 10, 2011

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

Table 1. Outline of the Guidelines Development Process (Updated November 3, 2008)

Topic Comment

Goal of the 

guidelines

Provide guidance to HIV care practitioners on the optimal use of ARV agents for the treatment 

of HIV 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 

disclosure

All members of the Panel submit a written financial disclosure annually reporting any 

association with manufacturers of ARV drugs or diagnostics used for management of HIV 

infections. A list of the latest disclosures is available on the AIDSinfo Web site 

(http://aidsinfo.nih.gov/contentfiles/AA_Roster.pdf).

Users of the 

guidelines HIV treatment providers

Developer Panel on Antiretroviral Guidelines for Adults and Adolescents—a working group of the 

OARAC

Funding source Office of AIDS Research, NIH

Evidence 

collection

The recommendations in the guidelines are generally based on studies published in peerreviewed 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safety, unpublished data presented at major conferences or prepared by the FDA and/or 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 

grading As described in Table 2

Method of 

synthesizing data

Each section of the guidelines is assigned to a working group of Panel members with expertise 

in the area 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 comments After release of an update on the AIDSinfo Web site, the public is given a 2-week period to 

submit 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.