Evaluation and Management of Early HIV Infection, Clinical Practice Guideline Number 7

212 Pages·1994·12.7 MB·English

by  Agency for Health Care Policy and Research

Clinical Practice Guideline
Number 7
Evaluation and Management
of Early HIV Infe
U.S. Department of Health and Human S
Public Health Service
Agencyfor Health Care Policy and Research
The Agency for Health Care Policy and Research (AHCPR) was
established in December 1989 under Public Law 101-239 (Omnibus
Budget Reconciliation Act of 1989) to enhance the quality, appropri-
ateness, and effectiveness ofhealth care services and access to these
AHCPR
services. carries out its mission by conducting and supporting
general health services research, including medical effectiveness
research, facilitating development ofclinical practice guidelines, and
disseminating research findings and guidelines to health care
providers, policymakers, and the public.
The legislation also established within AHCPR the Office ofthe
Forum for Quality and Effectiveness in Health Care (the Forum).
The Forum has primary responsibility for facilitating the develop-
ment, periodic review, and updating ofclinical practice guidelines.
The guidelines will assist practitioners in the prevention, diagnosis,
treatment, and management ofclinical conditions.
Other components ofAHCPR include the following. The Center
for Medical Effectiveness Research has principal responsibility for
patient outcomes research and studies ofvariations in clinical practice.
The Center for General Health Services Extramural Research sup-
ports research on primary care, the cost and financing ofhealth care,
and access to care for underserved and rural populations. The Center
for General Health Services Intramural Research uses large data sets
for policy research on national health care expenditures and utiliza-
tion, hospital studies, and long-term care. The Center for Research
Dissemination and Liaison produces and disseminates findings from
AHCPR-supported research, including guidelines, and conducts
research on dissemination methods. The Office ofHealth Technology
Assessment responds to requests from Federal health programs for
assessment ofhealth care technologies. The Office of Science and
Data Development develops specialized data bases for patient out-
comes research.
Guidelines are available in formats suitable for health care practi-
AHCPR
tioners, the scientific community, educators, and consumers.
invites comments and suggestions from users for consideration in
development and updating offuture guidelines. Please send written
comments to Director, Office ofthe Forum, AHCPR, Willco Building,
MD
Suite 310, 6000 Executive Boulevard, Rockville, 20852.
Clinical Practice Guideline
Number 7
Evaluation and
Management
of
Early HIV Infection
Office of Minority Health
eEarly •H•I.V. Inxfect*.-ion Rres.ou,_rce„Cie~nfer
Guideline Panel ^ T u '°°7
»WAa/sahin. gton, DC
20013-/70303/7
Wafaa El-Sadr, MD, MPH, Co-Chair
James M. Oleske, MD, MPH, Co-Chair
MD
Bruce D. Agins,
Kay A. Bauman, MD, MPH
MD
Carol L. Brosgart,
MD
Gina M. Brown,
Jaime V. Geaga, PA-C, MPH
Deborah Greenspan, BDS, DSc, ScD
Karen Hein, MD, BMS
William L. Holzemer, RN, PhD
Rudolph E. Jackson, MD
Michael K. Lindsay, MD, MPH
Harvey J. Makadon, MD
Martha W. Moon, MS, RN
Claire A. Rappoport, MS
Gwendolyn Scott, MD
Walter W. Shervington, MD
Lawrence C. Shulman, ACSW
Constance B. Wofsy, MD, MA
U.S. Department of Health and Human Services
Public Health Service
Agencyfor Health Care Policy and Research
AHCPR Publication No. 94-0572
January 1994
Guideline Development and Use
Guidelines are systematically developed statements to assist practi-
tioner and patient decisions about appropriate health care for specific
clinical conditions. This guideline was developed by a multidiscipli-
nary panel ofprivate-sector clinicians and other experts convened by
the Agency for Health Care Policy and Research (AHCPR). The
panel employed an explicit, science-based methodology and expert
clinicaljudgment to develop specific statements on patient assessment
and management for the clinical condition selected.
Extensive literature searches were conducted, and critical reviews
and syntheses were used to evaluate empirical evidence and signifi-
cant outcomes. Peer review and field review were undertaken to eval-
uate the validity, reliability, and utility ofthe guideline in clinical prac-
tice. The panel's recommendations are primarily based on the
published scientific literature. When the scientific literature was
incomplete or inconsistent in a particular area, the recommendations
reflect the professionaljudgment ofpanel members and consultants.
In some instances, there was not unanimity ofopinion.
The guideline reflects the state ofknowledge, current at the time of
publication, on effective and appropriate care. Given the inevitable
changes in the state ofscientific information and technology, periodic
review, updating, and revision will be done. We believe that the
AHCPR-assisted clinical guideline development process will make
positive contributions to the quality ofcare in the United States. We
encourage practitioners and patients to use the information provided
in this clinical practice guideline. The recommendations may not be
appropriate for use in all circumstances. Decisions to adopt any partic-
ular recommendation must be made by the practitioner in light of
available resources and circumstances presented by individual patients.
MD
J. Jarrett Clinton,
Administrator
Agencyfor Health Care Policy and Research
Publication ofthisguideline doesnotnecessarily representendorsementby the
U.S. DepartmentofHealth andHuman Services.
Foreword
According to the World Health Organization, between 30 and 40
million men, women, and children around the world will be infected
with the human immunodeficiency virus (HIV) by the year 2000.
Others have estimated that this number may be as high as 110 million.
By the turn ofthe century, acquired immunodeficiency syndrome
(AIDS) will be the third most common cause ofdeath in the United
States. This growing presence ofHIV necessitates that primary care
providers become involved in and knowledgeable about HIV care.
The growing population ofindividuals and their families living with
HIV also need guidance in seeking and accessing appropriate care.
This guideline provides such recommendations for health care
providers and people living with HIV. Philosophically, it recognizes
the unique character ofthe HIV epidemic and the need for a close
partnership ofproviders and consumers. The expert panel that pre-
pared the guideline included representation from both groups in its
membership and among the peer reviewers.
Because appropriate assessment and treatment during the initial
phase of the infection can have great impact on an individual's quality
of life, the panel focused on specific aspects ofevaluating and manag-
ing early HIV infection. Also included are discussion and recommen-
dations relating to non-medical issues which are intimately related to
HIV
care.
Thus, the panel's challenge was to include specific medical care
approaches for the provider within the broader social and psychologi-
cal concerns ofthe patient. This document provides recommenda-
tions for a wide range ofissues, including immunologic monitoring,
specific treatments for HIV infection and commonly associated infec-
tions such as tuberculosis and syphilis, issues affecting special groups
(such as women, children, and adolescents), case management, and
health care policy. It should be noted that the guideline does not
address many other areas important to early HIV care.
The past decade has seen many changes in the management of
individuals living with HIV infection. The pace of advances in HIV
care will make it imperative to update this guideline continually.
Although there remain many issues that this panel has not addressed
(these are enumerated throughout the guideline), the guideline
provides a model for addressing issues of importance to individuals
and families living with HIV.
Early HIV Infection Guideline Panel
in

Abstract
This guideline is a manual ofselected protocols for the evaluation
and management ofthe initial stage ofinfection caused by the human
immunodeficiency virus (HIV). It consists ofthe recommendations of
a national, private-sector panel ofphysicians, dentists, nurses, nurse
practitioners, physician assistants, social workers, and medical con-
sumers. These recommendations were made as a result of an exhaus-
tive search and analysis ofrelevant literature and the extensive clinical
experience and expertise ofpanel participants. Whenever possible,
the recommendations were based on an evaluation ofpublished evi-
dence. When scientific evidence was inadequate, panel consensus was
used as the basis for recommendations. Each recommendation is fol-
lowed by a rating that indicates the degree to which it is evidence
based. Public testimony, peer review, and a feasibility review were also
part ofthe guideline's development process.
Key topics addressed in the guideline include: antiretroviral ther-
apy and disclosure ofHIV status; monitoring ofCD4 cell counts and
initiation ofPCP prophylaxis; testing and preventive therapy for
tuberculosis and syphilis; conduct and timing oforal examination, eye
examination, and Papanicolaou smear assessment; pregnancy counsel-
ing; care for adolescents with HIV infection; evaluation and manage-
ment ofearly HIV infection in infants and children; case management
for persons living with HIV; and access and availability ofcare. It
should be noted that the guideline does not represent a comprehen-
sive guide to early HIV care; rather, it details only selected aspects of
such care.
This documentis in the publicdomain and may be used and reprinted
without special permission, except for those copyrighted materials noted
forwhich furtherreproduction is prohibited without the specificpermis-
AHCPR
sion ofcopyright holders. appreciates citation as to source, and
the suggested format is provided below.
El-SadrW, Oleske JM, Agins BD et al. Evaluation andManagementof
Early HIVInfection. ClinicalPractice GuidelineNo. 7. AHCPR Publica-
tion No. 94-0572. Rockville, MD: Agency for Health Care Policy and
Research, Public Health Service, U.S. Department ofHealth and Human
Services, January 1994.

Panel Members KarenHein,MD,BMS
Professor, Department ofPediatrics
WafaaEl-Sadr,MD,MPH Director, AdolescentAIDS Program
Panel Co-chair AlbertEinstein College ofMedicine
AssociateProfessor of
William L. Holzemer,
ClinicalMedicine RN, PhD
Columbia University Professor and Associate Deanfor
Chief, Division ofInfectious Research
Diseases
University ofCalifornia,
HarlemHospital Center
SanFrancisco
JamesM. Oleske,MD,MPH Rudolph£.Jackson,MD
Panel Co-chair
Professor ofPediatrics
Francois-XavierBagnoud
Morehouse SchoolofMedicine
ProfessorofPediatrics
Director, Division ofAllergy, Michael K. Lindsay,MD,MPH
Immunology, and Infectious Associate Professor
Diseases Grady MemorialHospital
NewJerseyMedical School HarveyJ.Makadon,MD
MD
BruceD.Agins, Assistant ProfessorofMedicine
AssistantMedical Director, Harvard Medical School
AIDS Institute MarthaW. Moon,MS, RN
NY
State Department ofHealth Nurse Practitioner
KayA. Bauman,MD,MPH Claire A. Rappoport,MS
JohnA. Burns School ofMedicine SanFrancisco Area AIDS
Wahiawa GeneralHospital
Education andTraining Center
MD
Carol L. Brosgart, SanFrancisco General Hospital
Medical Director Gwendolyn Scott,MD
EastBayAIDS Center
Professor, Department ofPediatrics
AltaBates Medical Center
University ofMiami
MD
GinaM. Brown, School ofMedicine
Department ofObstetrics and WalterW. Shervington,MD
Gynecology
Division ofMental Health
Columbia Presbyterian Office ofHuman Services
Medical Center Baton Rouge, LA
MPH
JaimeV. Geaga, PA-C, Lawrence C. Shulman,MSW, ACSW
Filipino Task Force on AIDS
Sociomedical Resource Associates
Deborah Greenspan, Constance B. Wofsy,MD,MA
BDS, DSc, ScD
Professor ofClinical Medicine
Clinical Professor
University ofCalifornia,
Division ofOral Medicine
SanFrancisco
University ofCalifornia,
SanFrancisco
vn
Acknowledgments
It was the best oftimes, it was the worst oftimes, it was the age
ofwisdom, it was the age offoolishness, it was the epic ofbelief,
it was the epic ofincredulity, it was the season ofLight, it was the
season ofDarkness, it was the spring ofhope, it was the winter
ofdespair...
Charles Dickens, A Tale ofTwo Cities
We have lived with the acquired immunodeficiency syndrome
(AIDS) epidemic, witnessing every day its paradoxes. People living
with the human immunodeficiency virus (HIV) not only live with the
fear, pain, and uncertainty ofthe disease, they also endure prejudice,
scorn, and rejection by society. Yet, persons living with HIV give sup-
port and encouragement to others and, by their example, change igno-
rance and prejudice to understanding and compassion. Our patients
have enriched our lives and redefined the limits ofour professions.
An orphaned child, known to have HIV, is welcomed into an
A
extended or foster family. homosexual man, unwelcomed and dis-
dained by his natural family, is offered profound love and support from
his community. A woman, alone, struggling, neglecting her own needs
for her child, crying for help, finally finds others who listen and care.
The nurse, the social worker, the doctor, the psychologist, the out-
reach worker, the counselor, the volunteer often have been the only
family for many living with HIV. These colleagues, including the mem-
bers and the staffofthis panel, have quietly and persistently struggled
to provide compassionate care to people and families living with HIV.
These many generous acts ofkindness, courage, and commitment,
and the people behind them, have inspired and guided us throughout
this guideline process. We are honored to be among those striving
in these "worst oftimes" toward a future without HIV, a true "best
oftimes."
Vlll