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Guideline Summary
Guideline Title
Diagnosis and management of acute HIV infection.
Bibliographic Source(s)
New York State Department of Health. Diagnosis and management of acute HIV infection. New York (NY): New York State Department of Health; 2010 Jan. 8 p. [11 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Acute human immunodeficiency virus (HIV) infection

Note: In the medical literature, the terms acute HIV infection, acute retroviral syndrome, acute HIV seroconversion, and primary HIV infection are interchangeable. For consistency, the term acute HIV infection is used in these guidelines.

Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Allergy and Immunology
Family Practice
Infectious Diseases
Internal Medicine
Medical Genetics
Obstetrics and Gynecology
Preventive Medicine
Intended Users
Advanced Practice Nurses
Health Care Providers
Nurses
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)

To provide guidelines for diagnosis and management of acute human immunodeficiency (HIV) infection

Target Population

Individuals with suspected or confirmed acute human immunodeficiency virus (HIV) infection

Interventions and Practices Considered

Diagnosis

  1. High degree of clinical awareness to assess nonspecific signs and symptoms
  2. Plasma human immunodeficiency virus ribonucleic acid (HIV RNA) assay
  3. Polymerase chain reaction (PCR) testing
  4. Confirmatory HIV antibody testing

Management

  1. Partner notification
  2. Patient counseling about increased risk of HIV transmission and potential advantages and limitations of antiretroviral (ARV) therapy
  3. Resistance testing (genotypic assay)
  4. Referral for research opportunities as appropriate
  5. Consultation with a provider experienced in HIV treatment
  6. ARV therapy if indicated
Major Outcomes Considered
  • Rate of human immunodeficiency virus (HIV) transmission during acute infection
  • Effect of early antiretroviral treatment
  • Quality of life
  • Rate of disease progression

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Not stated

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Quality of Evidence for Recommendation

  1. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
  2. One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes
  3. Expert opinion
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

AIDS Institute clinical guidelines are developed by distinguished committees of clinicians and others with extensive experience providing care to people with human immunodeficiency virus (HIV) infection. Committees* meet regularly to assess current recommendations and to write and update guidelines in accordance with newly emerging clinical and research developments.

The Committees* rely on evidence to the extent possible in formulating recommendations. When data from randomized clinical trials are not available, Committees rely on developing guidelines based on consensus, balancing the use of new information with sound clinical judgment that results in recommendations that are in the best interest of patients.

* Current committees include:

  • Medical Care Criteria Committee
  • Committee for the Care of Children and Adolescents with HIV Infection
  • Dental Standards of Care Committee
  • Mental Health Guidelines Committee
  • Committee on the Health of Women with HIV Infection
  • Committee on the Care of Substance Users with HIV Infection
  • Physician's Prevention Advisory Committee
  • Pharmacy Advisory Committee
Rating Scheme for the Strength of the Recommendations

Strength of Recommendation

  1. Strong recommendation for the statement
  2. Moderate recommendation for the statement
  3. Optional recommendation
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Description of Method of Guideline Validation

All guidelines developed by the Committee are externally peer reviewed by at least two experts in that particular area of patient care, which ensures depth and quality of the guidelines.

Recommendations

Major Recommendations

Definitions for the quality of the evidence (I, II, III) and strength of recommendation (A-C) are provided at the end of the "Major Recommendations" field.

What's New -- January 2010 Update

The Medical Care Criteria Committee recognized the need to raise clinical awareness for assessment and identification of acute human immunodeficiency virus (HIV) infection; consequently, these guidelines have been revised to emphasize the importance of testing for acute HIV infection, especially in the setting of a febrile, "flu"-, or "mono"-like illness that is not otherwise explained (see Section II. Presentation and Diagnosis of Acute HIV Infection).

Presentation and Diagnosis of Acute Human Immunodeficiency Virus (HIV) Infection

Clinicians should evaluate the following populations for acute HIV infection, particularly when they present with a febrile, "flu"-, or "mono"-like illness that is not otherwise explained:

  • Those who present for HIV testing (AIII)
  • Those who report a recent sexual or parenteral exposure with a known HIV-infected partner or a partner of unknown HIV serostatus in the past 2 to 6 weeks (AII)
  • Men who report having unsafe sexual practices with other men (AII)
  • Those who report needle-sharing (AII)
  • Those who present with a newly diagnosed sexually transmitted infection (AII)
  • Those who present with aseptic meningitis (AII)
  • Pregnant or breastfeeding patients (AIII)

When acute HIV infection is suspected, a plasma HIV ribonucleic acid (RNA) assay should be used in conjunction with an HIV-1 antibody test to diagnose acute HIV infection. (AII) Low-level positive polymerase chain reaction (PCR) results (<5000 copies/mL) are often not diagnostic of acute HIV infection and should be repeated to exclude a false-positive result. (AII)

Confirmatory HIV antibody testing should be performed 3 to 6 weeks after diagnosis by HIV RNA testing. (AII)

Key Point:

The diagnosis of acute HIV infection requires a high degree of clinical awareness. The nonspecific signs and symptoms of acute HIV infection are often not recognized. Diagnostic HIV RNA testing should be considered for patients who present with compatible symptoms (see Appendix A in the original guideline document for an extensive list of signs and symptoms of acute HIV infection), particularly in the context of a sexually transmitted infection or a recent sexual or parenteral exposure with a known HIV-infected partner or a partner of unknown HIV serostatus.

Diagnosis

Key Point:

Patients undergoing HIV testing who are not suspected to be in the acute stages of infection should receive HIV antibody testing according to standard protocol (see the New York State Department of Health [NYSDoH] guideline Diagnostic, Monitoring, and Resistance Laboratory Tests for HIV External Web Site Policy). Antibody test results that are initially negative should be followed up with HIV antibody testing at 3 months to identify HIV infection in individuals who may not yet have seroconverted at the time of initial presentation.

Management of Acute HIV Infection

Clinicians should offer assistance with partner notification, or refer patients to other sources for partner notification assistance (Contact Notification Assistance Program [CNAP], Partner Assistance Program [PNAP]).

Clinicians should counsel patients about the increased risk of transmitting HIV during acute HIV infection. (AII)

Clinicians should obtain baseline genotypic testing in the setting of acute infection, regardless of whether antiretroviral (ARV) therapy is being initiated. (AIII)

As part of the management of acute HIV infection, clinicians should:

  • Consult with a provider who has extensive experience in HIV treatment to determine whether to initiate treatment and to discuss possible ARV regimens (see Clinical Education Initiative External Web Site Policy sites available for phone consultation) (AIII)
  • Refer for research opportunities as appropriate (see Appendix B in the original guideline document) (AIII)
  • Counsel patients regarding potential advantages and limitations of ARV therapy during acute infection (AIII)

If the clinician and patient have made a decision to initiate ARV therapy to treat acute HIV infection, then:

  • Treatment should be implemented with the goal of suppressing plasma HIV RNA to below detectable levels (AII)
  • Therapy should not be withheld while awaiting the results of recommended resistance testing; adjustments may be made to the regimen once resistance results are available (AII)

Key Points:

  • Because there are insufficient data to make firm conclusions regarding specific drug recommendations for treating acute HIV infection, a provider with extensive experience in HIV treatment should be consulted when choosing an ARV regimen for a patient with acute HIV infection. The New York State Department of Health (NYSDOH) AIDS Institute's Clinical Education Initiative line External Web Site Policy is available for consultation.
  • The use of a genotypic assay may be preferred in the setting of acute infection because of its more rapid turnaround time. However, if the decision to initiate treatment has been made, therapy should not be withheld while awaiting the results of resistance testing. Adjustments may be made to the regimen once resistance results are available (see NYSDOH Antiretroviral Therapy guideline: section VI. 3. Resistance Assays External Web Site Policy).

Definitions:

Quality of Evidence for Recommendation

  1. One or more randomized trials with clinical outcomes and/or validated laboratory endpoints
  2. One or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes
  3. Expert opinion

Strength of Recommendation

  1. Strong recommendation for the statement
  2. Moderate recommendation for the statement
  3. Optional recommendation
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for selected recommendations (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Appropriate diagnosis and management of human immunodeficiency virus (HIV) infection
  • Detection of acute HIV infection provides an opportunity to follow patients prospectively soon after infection and thereby reduce disease progression and incidence of opportunistic infections (OIs). Because patients with a recent diagnosis of HIV are more likely to reduce risk behaviors if they are linked to primary HIV care than if they are not receiving care, early detection may also be a critical component of preventing further transmission.
Potential Harms
  • Disadvantages of antiretroviral (ARV) therapy
    • Adverse effects on quality of life as a result of drug toxicities and complex treatment regimens
    • Potential for the development of drug resistance if therapy fails due to nonadherence or to insufficient suppression of viral replication, which may limit future treatment options
    • Earlier commitment to lifetime ARV therapy
    • Less time to educate the patient about ARV therapy
    • Insufficient data regarding effectiveness of early treatment
  • Low-level positive polymerase chain reaction (PCR) results (<5000 copies/mL) are often not diagnostic of acute HIV infection and should be repeated to exclude a false-positive result.

Qualifying Statements

Qualifying Statements

When formulating guidelines for a disease as complex and fluid as human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), it is impossible to anticipate every scenario. It is expected that in specific situations, there will be valid exceptions to the approaches offered in these guidelines and sound reason to deviate from the recommendations provided within.

Implementation of the Guideline

Description of Implementation Strategy

The AIDS Institute's Office of the Medical Director directly oversees the development, publication, dissemination and implementation of clinical practice guidelines, in collaboration with The Johns Hopkins University, Division of Infectious Diseases. These guidelines address the medical management of adults, adolescents and children with human immunodeficiency virus (HIV) infection; primary and secondary prevention in medical settings; and include informational brochures for care providers and the public.

Guidelines Dissemination

Guidelines are disseminated to clinicians, support service providers, and consumers through mass mailings and numerous AIDS Institute-sponsored educational programs. Distribution methods include the HIV Clinical Resource website, the Clinical Education Initiative (CEI), the AIDS Educational Training Centers (AETC), and the HIV/AIDS Materials Initiative. Printed copies of clinical guidelines are available for order from the New York State Department of Health (NYSDOH) Distribution Center.

Guidelines Implementation

The HIV Clinical Guidelines Program works with other programs in the AIDS Institute to promote adoption of guidelines. Clinicians, for example, are targeted through the CEI and the AETC. The CEI provides tailored educational programming on site for health care providers on important topics in HIV care, including those addressed by the HIV Clinical Guidelines Program. The AETC provides conferences, grand rounds and other programs that cover topics contained in AIDS Institute guidelines.

Support service providers are targeted through the HIV Education and Training initiative which provides training on important HIV topics to non-physician health and human services providers. Education is carried out across the State as well as through video conferencing and audio conferencing.

The HIV Clinical Guidelines Program also works in a coordinated manner with the HIV Quality of Care Program to promote implementation of HIV guidelines in New York State. By developing quality indicators based on the guidelines, the AIDS Institute has created a mechanism for measurement of performance that allows providers and consumers to know to what extent specific guidelines have been implemented.

Finally, best practices booklets are developed through the HIV Clinical Guidelines Program. These contain practical solutions to common problems related to access, delivery or coordination of care, in an effort to ensure that HIV guidelines are implemented and that patients receive the highest level of HIV care possible.

Implementation Tools
Slide Presentation
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
New York State Department of Health. Diagnosis and management of acute HIV infection. New York (NY): New York State Department of Health; 2010 Jan. 8 p. [11 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Jan
Guideline Developer(s)
New York State Department of Health - State/Local Government Agency [U.S.]
Source(s) of Funding

New York State Department of Health

Guideline Committee

Medical Care Criteria Committee

Composition of Group That Authored the Guideline

Chair: Barry S Zingman, MD, Montefiore Medical Center, Bronx, New York

Members: Judith A Aberg, MD, New York University School of Medicine, New York, New York; Bruce D Agins, MD, MPH, New York State Department of Health AIDS Institute, New York, New York; Barbara Chaffee, MD, MPH, United Health Services, Binghamton, New York; Steven M Fine, MD, PhD, University of Rochester Medical Center, Rochester, New York; Barbara E Johnston, MD, Saint Vincent's-Manhattan Comprehensive HIV Center, New York, New York; Jason M Leider, MD, PhD, North Bronx Healthcare Network of Jacobi and North Central Bronx Hospitals, Bronx, New York; Joseph P McGowan, MD, FACP Center for AIDS Research & Treatment, North Shore University Hospital, Manhasset, New York; Samuel T Merrick, MD, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York; Rona M Vail, MD, Callen-Lorde Community Health Center, New York, New York

Liaisons: Sheldon T Brown, MD, Liaison to the Department of Veterans Affairs Medical Center, Bronx Veteran Affairs Medical Center, Bronx, New York; Douglas G Fish, MD, Liaison to the New York State Department of Corrections, Albany Medical College, Albany, New York; Peter G Gordon, MD, Liaison to the HIV Quality of Care Advisory Committee, Columbia University College of Physicians and Surgeons New York, New York; Kinga Cieloszyk, MD, MPH, Liaison to the New York City Department of Health and Mental Hygiene, Treatment and Housing Bureau of HIV/AIDS Prevention and Control, New York, New York; Joseph R Masci, MD, Liaison to New York City Health and Hospitals Corporation, Elmhurst Hospital Center, Elmhurst, New York; John M Conry, PharmD, BCPS, Liaison to Pharmacy Advisory Committee, Saint John's University, Jamaica, New York; William Valenti, MD, FIDSA, Liaison to the Medical Society of the State of New York, University of Rochester School of Medicine, Rochester, New York

AIDS Institute Staff Physicians: Charles J Gonzalez, MD, New York State Department of Health AIDS Institute, New York, New York; Cheryl A Smith, MD, New York State Department of Health AIDS Institute, New York, New York

Principal Investigator: John G Bartlett, MD, The Johns Hopkins University, Baltimore, Maryland

Principal Contributors: Jessica E Justman, MD, Columbia University, New York; Barry S Zingman, MD, Montefiore Medical Center, Bronx; Rona M Vail, MD, Callen-Lorde Community Health Center, New York; Charles J Gonzalez, MD, New York State Department of Health AIDS Institute, New York

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available from the New York State Department of Health AIDS Institute Web site External Web Site Policy.

Availability of Companion Documents

The following is available:

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on August 30, 2010.

Copyright Statement

This NGC summary is based on the original guideline, which is copyrighted by the guideline developer. See the New York State Department of Health AIDS Institute Web site External Web Site Policy for terms of use.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouseâ„¢ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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