About This Guideline

This guideline was updated June 2017. Some information you are looking for may have moved. Please update your bookmarks if necessary.

NYSDOH AIDS Institute Medical Care Criteria Committee (MCCC)

The New York State Department of Health (NYSDOH) AIDS Institute (AI) protects and promotes the health of NYS’s diverse population through disease surveillance and the provision of quality services for prevention, health care, and psychosocial support for those affected by HIV/AIDS, sexually transmitted diseases, viral hepatitis, and related health concerns. In addition, the NYSDOH AI promotes the health of LGBT populations, substance users, and the sexual health of all New Yorkers. To update its existing (2009) guideline on immune reconstitution inflammatory syndrome in patients with HIV infections, the AIDS Institute clinical guidelines program prioritized development of this updated guideline on Management of IRIS.

Committee Makeup

Members of the Medical Care Criteria Committee (MCCC) (see Box A1: MCCC Leaders, Members, and IRIS Guideline Reviewers) were appointed by the NYSDOH AI to ensure representation of clinical practice in all major regions of the state, relevant medical disciplines and sub-specialties, key NYS agencies, community stakeholders, and patient advocates. Individuals confirmed as Committee members are required to disclose any potential conflicts of interest; disclosures are reviewed and approved by the NYSDOH AIDS Institute Office of the Medical Director (see Funding and Financial Disclosure of Potential Conflicts of Interest, below).

Committee Role

Committee members actively participate in guideline development, including evidence review, drafting of recommendations and text, manuscript review, consensus approval of all recommendations, and rating of recommendations.

Committee Leadership

Working with the lead author, the MCCC Planning Group of Committee leaders reviewed and refined the manuscript, facilitated consensus approval of all recommendations, and addressed feedback from external peer and consumer reviewers.

Johns Hopkins University (JHU) Editorial Role

The JHU editorial team coordinated, guided, and documented all Committee activities, and edited the guideline material for clarity, flow, and style.

MCCC Planning Group for IRIS (all Committee members and reviewers are listed in Box A1, below)
  • Samuel T. Merrick, MD, Chair
  • Joseph P, McGowan, MD, FACP, FIDSA, Vice-Chair
  • Judith A. Aberg, MD, FIDSA, FACP, Chair Emeritus
  • Charles J. Gonzalez, MD, AIDS Institute Deputy Medical Director
  • Christopher J. Hoffmann, MD, MPH, JHU Principal Investigator
  • Steven M. Fine, MD, PhD, Lead Author
JHU Editorial and Program Management Team
  • Mary Beth Hansen, MA, Project Director
  • Christina Norwood, MS, ELS, Senior Editor
  • Johanna Gribble, MA, Medical Editor
  • Jen Ham, MPH, Medical Editor
  • Jesse Ciekot, Program Coordinator
Box A1. MCCC Leaders, Members, and IRIS Guideline External Reviewers
Guideline Program Leadership
  • Medical Director: Bruce D. Agins, MD, MPH, New York State Department of Health AIDS Institute, New York, NY
  • Deputy Director: Lyn C. Stevens, MS, NP, ACRN, New York State Department of Health AIDS Institute, Albany, NY
  • Principal Investigator: Christopher J. Hoffmann, MD, MPH, Johns Hopkins University School of Medicine, Baltimore, MD
Medical Care Criteria Committee Leadership
  • Chair: Samuel T. Merrick, MD, New York-Presbyterian Hospital, New York, NY
  • Vice-Chair: Joseph P. McGowan, MD, FACP, FIDSA, North Shore University Hospital, Manhasset, NY
  • Chair Emeritus: Judith A. Aberg, MD, FIDSA, FACP, Icahn School of Medicine at Mount Sinai, New York, NY
Contributing Members
  • James C.M. Brust, MD, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY
  • Elliot DeHaan, MD, SUNY Downstate Medical Center, Brooklyn, NY
  • Steven M. Fine, MD, PhD, University of Rochester Medical Center, Rochester, NY
  • Jack Fuhrer, MD, Stony Brook University Medical Center, East Setauket, NY
  • Christine A. Kerr, MD, Hudson River HealthCare, Beacon, NY
  • Luz Amarilis Lugo, MD, Mount Sinai Comprehensive Health Program-Downtown, New York, NY
  • Cynthia H. Miller, MD, Albany Medical College, Albany, NY
  • Gene Morse, PharmD, FCCP, BCPS, University at Buffalo, Buffalo, NY
  • David C. Perlman, MD, Mount Sinai Beth Israel, New York, NY
  • Noga Shalev, MD, Columbia University Medical Center, New York, New York
  • Rona M. Vail, MD, Callen-Lorde Community Health Center, New York, NY
Agency, Consumer, and Program Liaisons
  • Medical Society of the State of New York: William M. Valenti, MD, FIDSA, Trillium Health, Rochester, NY
  • New York City Department of Health and Mental Hygiene: Demetre Daskalakis, MD, MPH; Julie E. Myers, MD, MPH, Long Island City, NY
  • New York City Health + Hospitals Liaison: Carlos Salama, MD, Elmhurst Hospital Center, Elmhurst, NY
  • New York State Department of Corrections and Community Supervision: Carl J. Koenigsmann, MD, Albany, NY
  • New York State Department of Health AIDS Institute: Charles J. Gonzalez, MD and Cheryl A. Smith, MD, NYSDOH AI, New York, NY; Antonio E. Urbina, MD, Mount Sinai St Luke’s, New York, NY
  • New York State Department of Health AIDS Institute HIV Quality of Care Advisory Committee: Peter G. Gordon, MD, Columbia University College of Physicians and Surgeons, New York, NY
  • New York State Department of Health Office of Health Insurance Programs: Douglas G. Fish, MD, NYSDOH,Albany, NY
  • New York State Department of Veterans Affairs Medical Center: Sheldon T Brown, MD, James J. Peters Veterans Affairs Medical Center, Bronx, NY
  • Treatment Action Group: Jeremiah Johnson, Treatment Action Group (TAG), New York, NY
  • Women’s Health: Gina M. Brown, MD, Bethesda, MD
External Peer Reviewers
  • Susan L. Koletar, MD, FACP, FIDSA, Division Director, Division of Infectious Diseases, The Ohio State University, Columbus, OH
  • Talia Swartz, MD, PhD, Assistance Professor of Medicine, Infectious Diseases, The Mount Sinai Hospital, New York, MY

Funding and Disclosure of Potential Conflicts of Interest

This guideline was updated June 2017. Some information you are looking for may have moved. Please update your bookmarks if necessary.

Funding: New York State funds supported development of the Management of Immune Reconstitution Inflammatory Syndrome (IRIS) guideline through a grant awarded to the Johns Hopkins University School of Medicine, Division of Infectious Diseases, from the New York State Department of Health AIDS Institute.

Conflicts of interest: All active MCCC members, invited consultants and coauthors, peer reviewers, and program staff are required to disclose financial relationships with commercial entities, including gifts that may be actual conflicts of interest or may be perceived as conflicts. These individuals must disclose financial relationships annually, for themselves, their partners/spouses, and their organization/institution. On their annual disclosures, MCCC members are asked to report for the previous 12 months and the upcoming 12 months. Box A2, below, lists reported conflicts.

Management of COIs: All reported financial relationships with commercial entities are reviewed by the NYSDOH AI guidelines program to assess the potential for undue influence on guideline recommendations made by the Committee. For the Committee members reporting conflicts, it was determined that the potential for exertion of undue influence on recommendations was exceedingly low to non-existent.

All guideline recommendations received consensus approval of the full MCCC, and the final review and approval of the recommendations was performed by the Committee Chair, and the NYSDOH AI Medical Director and Deputy Medical Director, none of whom reported conflicts of interest.

External peer reviewers were also required to submit conflict of interest/financial disclosure information, which were similarly screened. Neither peer reviewer reported conflicts.

Box A2. Reported Conflicts of Interest/Financial Disclosure Results
Committee/Guideline Role Relationships disclosed for the previous and/or upcoming 12 months
Planning Group Member Research support: Gilead, ViiV; scientific advisor: Merck (JM)
Planning Group Member Scientific advisor: Merck (JA)
Committee Member Scientific advisor: GFORCE (ED)
Committee Member Consultant: Roche Diagnostics; Grant or research support: Gilead
Committee Member Consultant: Gilead, Merck, ViiV, BMS

Recommendation Development and Ratings Process

This guideline was updated June 2017. Some information you are looking for may have moved. Please update your bookmarks if necessary.

The clinical recommendations presented in this guideline were developed by consensus based on a synthesis of the current evidence collected through review of current published peer-reviewed literature. If no data were available, the recommendations are based on expert opinion, and this status is indicated in the rating and in the text.

The Planning Group met via monthly teleconferences over approximately 24 months to finalize the guideline and reach consensus on recommendations and rationale. Once consensus among the Planning Group members was reached, the guideline was reviewed by the full MCCC, and consensus was reached on all recommendations. These deliberations were conducted by teleconference; MCCC members were invited to submit comments in writing as well. Committee review discussions were recorded, and recordings were reviewed carefully to ensure that all decisions and changes were captured and integrated into the manuscript.

Members of the Planning Group then individually reviewed the evidence for each recommendation and assigned a two-part rating (see Box A3). The individual ratings were compiled into a report distributed to all raters, and conference call discussions were held to deliberate ratings for which consensus was needed. Once all raters agreed on the interpretation of evidence and ratings for all recommendations, the guideline was sent to the NYSDOH AI for review and approval.

Box A3. AIDS Institute HIV Clinical Guidelines Program Recommendations Rating Scheme
Strength of Recommendation Quality of Supporting Evidence
A = Strong 1 = At least 1 randomized trial with clinical outcomes and/or validated laboratory endpoints
B = Moderate 2 = One or more well-designed, nonrandomized trial or observational cohort study with long-term clinical outcomes
C = Optional 3 = Expert opinion

External Review

This guideline was updated June 2017. Some information you are looking for may have moved. Please update your bookmarks if necessary.

Two external peer reviewers recognized for their experience and expertise in HIV primary care were identified by program leaders (see Box A1). These individuals submitted a financial disclosure statement for the purpose of identifying potential conflicts of interest before participating as peer reviewers; neither disclosed financial relationships with commercial entities in the 12 months prior or the 12 months following submission of the disclosure.

Peer reviewers were asked to review the guideline for accuracy, balance, clarity, and practicality of the recommendations for primary care providers. The Planning Group addressed peer review feedback; any conflicting opinions were resolved by the Committee chairs. Members of NYSDOH AI Community Advisory Committee also reviewed and commented on the guideline.

Guideline Updates

This guideline was updated June 2017. Some information you are looking for may have moved. Please update your bookmarks if necessary.

Members of the MCCC will monitor developments in management of IRIS in an ongoing, structured manner to maintain guideline currency. Once the guideline is published on the program website:, any updates will be made to the HTML document as needed.

Notification of newly published studies will be automated, and the Planning Group will review new data at least every 6 months. Newly published data that provide support for existing recommendations will be cited in the text, and the studies will be added to the reference list(s).

If newly published data prompt a revision to recommendations or rationale, the Planning Group will propose appropriate edits and determine whether the changes warrant review and approval by the entire MCCC. If MCCC review is required, a conference call will be convened for that purpose. Deletion of existing recommendations, addition of any new recommendations, and/or substantive changes to existing recommendations will prompt MCCC review and consensus.

The full guideline will be reviewed and updated on the 4th anniversary of original publication to prepare for publication of an updated guideline on or before the 5th anniversary of original publication.