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       Document 0048
 DOCN  CDC94048
 TI    QUICK REFERENCE GUIDE FOR CLINICIANS - Number 7: MANAGING EARLY HIV
       INFECTION
 DT    940100
 SO    U.S. Department of Health and Human Services; Public Health
       Service - Agency for Health Care Policy and Research
 TX    Contents

       Disclosure of HIV Status
    Evaluation and Medical Management in Adults
    Caring for Adolescents
    Evaluation and Medical Management in Infants and Children
    Case Management of Persons Living with HIV
    Algorithms

       Attention clinicians:

       The "Clinical Practice Guideline" on which this "Quick
       Reference Guide for Clinicians" is based was developed by an
       interdisciplinary, private-sector panel comprising health care
       professionals and consumer representatives. Panel members were:

       Wafaa El-Sadr, MD, MPH (Co-Chair)
       James M. Oleske, MD, MPH (Co-Chair)
       Bruce D. Agins, MD
       Kay Bauman, MD, MPH
       Carol Brosgart, MD
       Gina M. Brown, MD
       Jaime V. Geaga, PA-C
       Deborah Greenspan, DDS
       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, MSN
       Claire A. Rappoport, MS
       Walter W. Shervington, MD
       Lawrence C. Shulman, MSW
       Constance B. Wofsy, MD, MA

       For a description of the guideline development process and
       information about the sponsoring agency (Agency for Health Care
       Policy and Research), see the "Clinical Practice Guideline,
       Evaluation and Management of Early HIV Infection" (AHCPR
       Publication No. 94-0572). To receive another copy of the
       "Clinical Practice Guideline," this "Quick Reference Guide for
       Clinicians" (AHCPR Publication No. 94-0573), or the "Consumer
       Guides," "HIV and Your Child" (AHCPR Publication No. 94-0576)
       and "Understanding HIV" (AHCPR Publication No. 94-0574), call
       toll free: (800) 342-AIDS or write to:

       AHCPR HIV Guideline
       CDC National Clearinghouse
       Post Office Box 6003
       Rockville, MD 20849-6003

       Note: This "Quick Reference Guide for Clinicians" contains
       excerpts from the "Clinical Practice Guideline," but users
       should not rely on these excerpts alone. Clinicians should
       refer to the complete "Clinical Practice Guideline" for more
       detailed analysis and discussion of the available research,
       critical evaluation of the assumptions and knowledge of the
       field, health care decisionmaking, and references.Managing
       Early HIV Infection

       Purpose and Scope

       According to the World Health Organization, 30 to 40 million
       men, women, and children around the world will be infected with
       the human immunodeficiency virus (HIV) by the year 2000. By the
       turn of the century, acquired immunodeficiency syndrome (AIDS)
       will be the third most common cause of death in the United
       States. The increasing presence of HIV in every community
       necessitates that primary care providers become involved in and
       knowledgeable about caring for patients with HIV. The growing
       population of individuals living with HIV and their families
       also need guidance in seeking and accessing appropriate care.

       This "Quick Reference Guide" presents highlights from the
       "Clinical Practice Guideline on Evaluation and Management of
       Early HIV Infection." The "Guideline" focuses on the early
       stages of HIV infection because early recognition of HIV is
       becoming more common, and medical intervention in the early
       stages of HIV infection may be most effective in delaying
       life-threatening symptoms. In addition, and perhaps most
       important to primary care providers, early intervention and
       education often increase patient involvement in treatment,
       improve access to services, and slow the spread of the disease.

       This "Quick Reference Guide" and the "Guideline" were developed
       both for primary care providers and those who receive care. In
       the early years of the epidemic, the most severe complications
       of HIV infection received the most attention. The focus has
       since evolved to emphasize outpatient care, health maintenance,
       prevention of hospitalization, and integration of the patient
       and loved ones into a system that provides supportive services.
       Thus, primary care providers must be prepared to diagnose HIV
       infection, disclose test results, and evaluate and manage early
       HIV infection.

       Because the subject of early HIV care is so broad and complex,
       the "Guideline" is limited to selected elements of adult and
       pediatric care that are particularly significant for
       practitioners: disclosure of HIV status, monitoring of CD4
       lymphocyte counts; prevention of Pneumocystis carinii pneumonia
       (PCP) and tuberculosis; initiation of antiretroviral therapy;
       treatment of syphilis; eye and oral care; performance of
       Papanicolaou (Pap) smears; diagnosis of HIV infection in
       infants and children; monitoring of CD4 lymphocyte counts and
       initiation of antiretroviral therapy in infants and children;
       preventive therapy for PCP and assessment of neurologic
       problems in HIV-infected children; pregnancy counseling; and
       development of a comprehensive case management system for the
       patient that covers both social services and health care.
       Algorithms, found at the back of this Quick Reference Guide,
       show the sequence of events related to evaluating and managing
       early HIV infections in adults, adolescents, infants, and
       children.

       Because advances in the management of HIV infection are
       occurring at a rapid pace, providers should seek frequent
       updates.

       Published data were used to the greatest extent possible to
       formulate the recommendations in the "Guideline." In the
       "Guideline" and this "Quick Reference Guide," each
       recommendation is rated and labeled according to the degree to
       which it is data-based:

    Supported by evidence (SPE): Evidence from at least one
       well-designed, published, randomized controlled trial in the
       population for which the recommendation is made; or from at
       least one well-designed, published population-based study.

    Suggested by evidence (SGE): Consistent results from other
       study designs or studies in populations other than that for
       which the recommendation is made.

    Expert opinion (EO): Expert clinical experience described in
       the literature or consensus of panel members.

       Disclosing HIV Status

       Initial disclosure of HIV test results to the patient sets the
       foundation for the patient's acceptance, knowledge base, and
       attitudes about his or her condition. This in turn may
       dramatically affect patients' quality of life and their ability
       to care for themselves. The manner in which the test results
       are communicated to the patient is, therefore, extremely
       important.

       Provider Disclosure to Patient, Parent, or Guardian

    Before disclosing the results of HIV testing to a patient or
       the parent or guardian of a child who has been tested, assess
       the degree to which that person is prepared to receive the
       results. Consider the person's social, demographic, cultural,
       and psychological characteristics, which may be important
       factors in his or her ability to cope with the test results.
       (SGE)

    Disclosure and accompanying counseling should take place
       face-to-face. Discuss the natural history of HIV infection, the
       potential effects of HIV infection on physical and mental
       health, prevention of further HIV transmission, the role of
       health maintenance, and the availability of treatments. For
       adolescents, encourage the presence of a supportive adult.
       (SGE)

    Disclosure counseling provides an opportunity both to provide
       immediate interventions and to involve the patient in medical,
       mental health, social, and family-support networks. Immediate
       interventions should include assessing the patient for the
       potential for violence to himself/herself or others; ensuring
       that the patient receives a thorough evaluation, staging, and
       initial care; informing the patient of available services;
       scheduling the next appointment; addressing prevention of
       further HIV transmission; assessing the availability of a key
       support person (e.g., lover, partner, significant other,
       roommate, child, friend, parents, spouse, spiritual support
       person) and other care providers; and providing information on
       local and national sources of support. (EO)

    The provider should make referrals for any needed services that
       cannot be obtained on site. (EO)

       Provider Disclosure to Agencies

    Providers should know their State's HIV reporting requirements
       and educate patients about them (see page 4 for a
       State-by-State listing of HIV reporting requirements). (EO)

    Providers should ensure that patients are aware of the extent
       and limits of confidentiality of HIV test results. (EO)

       Patient Disclosure to Other Individuals and Agencies

       Primary care providers should help their patients appreciate
       why disclosure of their HIV infection may be useful in some
       situations and detrimental in others. In some States,
       disclosure of HIV infection enables a patient to become
       eligible for entitlement benefits.

       Disclosure to significant others may result in increased social
       support; it may also prompt a significant other to consider
       whether to seek HIV testing. Conversely, disclosure may result
       in housing discrimination, loss of employment or of child
       custody, reduction or cessation of health benefits, or
       rejection by a potential employer or a significant other.

    Through counseling and referrals as needed, the provider should
       explain and help the patient to understand the advantages and
       disadvantages of disclosing HIV status to others, including the
       potential for discrimination against persons with HIV
       infection. (EO)

    The patient should be strongly encouraged to disclose his or
       her HIV status to significant others, particularly sexual and
       needle-sharing partners. At the same time, providers must be
       aware of the potential for domestic violence when one or both
       partners has HIV infection. (SGE)

       Parent or Guardian Disclosure to Infected Children and Other
       Family Members

    The provider should assist parents and guardians in making
       decisions regarding disclosure of HIV infection to an infected
       child or adolescent and other family members. This assistance
       should consist of educating parents and guardians, and working
       with them to ensure that needed support services are in place
       during the process of disclosure. (EO)

       ______________________________________

       Reporting requirements for human immunodeficiency virus (HIV)
       infection

       By name             Anonymous           Not Required

       Alabama             Georgia             Alaska
       Arizona             Iowa                California
       Arkansas            Kansas              Connecticut
       Colorado            Kentucky            Delaware
       Idaho               Maine               Florida
       Illinois            Montana             Hawaii
       Indiana             New Hampshire       Louisiana
       Michigan            Oregon              Maryland2
       Minnesota           Rhode Island        Massachusetts
       Mississippi         Texas               Nebraska
       Missouri                                New Mexico
       Nevada                                  New York
       New Jersey1                             Pennsylvania
       North Carolina                          Vermont
       North Dakota                            Washington2
       Ohio                                    District of Columbia
       Oklahoma
       South Carolina
       South Dakota
       Tennessee1
       Utah
       Virginia
       West Virginia
       Wisconsin
       Wyoming1


       1 Implementation date, January, 1992.
       2 Requires reports of symptomatic HIV infection by name.

       Note: Current as of March 1, 1993. All States require reporting
       of acquired immunodeficiency syndrome (AIDS) cases by name at
       the State/local level.

       _____________________________________________

       Evaluation and Management of HIV-Infected Adults

       Early identification of HIV infection allows the provider to
       conduct a thorough medical and psychological assessment to
       define the immediate and long-term needs of the patient. A
       detailed medical history is a crucial first step in treatment
       and should include a review of the HIV test result, previous
       infections, and sexual and substance use history.

       A comprehensive physical examination, including assessments of
       eye and oral health, neurologic status, skin and lymph nodes,
       and HIV-associated signs and symptoms, accompanied by open
       discussion of the patient╒s concerns and fears, allows the
       provider to define the stage of HIV infection, determine the
       best treatment, and lay the foundation for an effective
       partnership with the patient. Algorithm 1 presents an overview
       of the selected elements of early HIV care covered in the
       "Guideline" and this "Quick Reference Guide." Tables 1, 2, and
       3 (see pages 21-24) list the drugs discussed here and in the
       Guideline, as well as dosages and adverse effects.

       Monitoring CD4 Lymphocytes and Initiating Antiretroviral
       Therapy and PCP Prophylaxis

       The assessment of immune status is a key element of the
       patient's initial evaluation. Measuring the number of CD4
       lymphocytes is the primary test for monitoring immune function.
       It establishes the stage of HIV infection, the prognosis of
       disease, and helps to determine the appropriateness of
       initiating antiretroviral therapy and prophylaxis for PCP and
       other opportunistic infections.

       Steps for carrying out this evaluation are presented in
       Algorithm 2. CD4 testing and specific treatments for pregnant
       women are shown in Algorithm 3. Other recommendations are
       listed here:

    The immune status of an HIV-infected individual should be
       assessed at the time of his or her initial medical evaluation.
       A CD4 lymphocyte count should be the primary test for
       monitoring immune function. (EO)

    The number of CD4 cells should be measured once every 6 months
       when the CD4 count is greater than 600 cells/■l and at least
       every 3 months when the CD4 count is between 200 cells/■l and
       600 cells/■l. More frequent measurements may be desirable if
       there is evidence of rapid decline in cell count of if the
       patient's symptoms become more severe. (EO)

    Ongoing measurement of CD4 cells below 200 cells/■l at least
       every 3 months may be necessary to track the effects of
       antiretroviral therapy and to determine the appropriate time
       for initiation of new preventive and therapeutic interventions.
       (EO)

    Antiretroviral therapy with zidovudine (the major
       antiretroviral therapy, formerly known as AZT, now ZDV) should
       be discussed with all HIV-infected individuals whose CD4 counts
       are less than 500 cells/■l. (SGE)

    Those patients who do not tolerate ZDV or have clinical
       progression of HIV infection on this treatment, should be
       offered therapy with didanosine (ddI) or dideoxycitidine (ddC).
       (SPE)

    Those patients who are tolerating ZDV may remain on ZDV;
       consider switching to ddI after a period of time, as some
       evidence suggests a benefit from this change. (EO)

    PCP prophylaxis should be initiated if any of the following
       conditions is met: (1) the CD4 count is less than 200 cells/■l
       (SPE); (2) there has been a prior episode of PCP (SPE); or, (3)
       oral candidiasis or constitutional symptoms such as unexplained
       fevers are present (SGE).

    Oral trimethoprim-sulfamethoxazole (TMP-SMX) is the preferred
       agent for PCP prophylaxis. (SPE)

    Other effective prophylactic agents include aerosolized
       pentamidine, oral dapsone, and a combination of oral dapsone
       and pyrimethamine. Consider their advantages and disadvantages
       in determining whether to use them. (SPE)

    In HIV-infected pregnant women, CD4 counts should be determined
       at the time of presentation for prenatal care. CD4 counts
       should be determined at delivery for those women who have
       received no prenatal care. (EO)

    If the count is 600 cells/■l or above, it need not be repeated
       during pregnancy, unless indicated by clinical symptoms. If the
       count is 200 cells/■l or less, it need not be repeated during
       pregnancy, according to current data. If the count is between
       200 cells/■l and 600 cells/■l, it should be repeated each
       trimester. (SGE)

    Discuss antiretroviral therapy with ZDV with HIV-infected
       pregnant women whose CD4 lymphocyte counts are less than 500
       cells/■l. (SGE)

    Providers should inform HIV-infected pregnant women of the
       benefits of early ZDV therapy and the potential for risks to
       the mother and fetus. (SGE)

    HIV-infected pregnant women should receive PCP prophylaxis
       according to the same guidelines used for other adults. (SGE)

       Testing and Preventive Therapy for Tuberculosis Infection

       The reemergence of tuberculosis (TB) as a major public health
       concern is especially important for HIV-infected individuals
       because the immunosuppression caused by the virus permits
       Mycobacterium tuberculosis infection to progress at an
       accelerated pace, and they are more likely to develop active
       TB. TB merits special consideration in the treatment of
       HIV-infected patients because it is readily communicable to
       others, management is different for HIV-infected patients than
       for non-HIV-infected patients, and, unlike many other
       opportunistic infections, it is preventable and may be curable
       if treated promptly.

       Screening

       The medical history for all HIV-infected individuals should
       include the following steps (see Algorithm 4): (a) assessment
       of previous TB infection or disease, past treatment or
       preventive therapy, and history of exposure to M. tuberculosis;
       (b) assessment of the risk for M. tuberculosis infection,
       including predisposing social conditions (e.g., household
       contacts, country of origin, homelessness, history of
       incarceration, residence in a congregate living situation); and
       (c) suggestive symptoms (e.g., cough, hemoptysis, fever, night
       sweats, weight loss). During the physical examination, the
       provider should seek indications of active disease (e.g.,
       abnormal pulmonary signs, documented weight loss). (SGE)


    The medical history for all HIV-infected individuals should
       also include an assessment of health and social conditions that
       may affect an individual's ability to complete a course of
       therapy, specifically, repeated failure to keep medical
       appointments, alcoholism, mental illness, and substance use.
       (SGE)

    All HIV-infected individuals, including those who have received
       BCG vaccination, should be screened, using purified protein
       derivative (PPD) for infection with M. tuberculosis during
       their initial evaluation. (SGE)

    All HIV-infected individuals should be screened for anergy
       using two control antigens in addition to PPD during their
       initial evaluation. (SGE)

    All HIV-infected individuals who are PPD-positive or anergic
       should receive a chest x-ray and clinical evaluation, and those
       who have symptoms suggestive of TB should receive a chest
       x-ray, regardless of their PPD or anergy status. (SGE)

    PPD and anergy testing should be repeated annually in persons
       who are neither PPD-positive nor anergic on initial evaluation.
       Persons who reside in areas where TB prevalence is high should
       be tested every 6 months. (SGE)

    All PPD-negative or anergic HIV-infected individuals who have
       recently been exposed to persons with suspected or confirmed TB
       should be immediately tested with PPD and anergy antigens.
       Repeat testing should be performed in 3 months. (SGE)

    PPD testing should be performed by the Mantoux method, using an
       intradermal injection of 0.1 ■l 5 TU PPD (intermediate
       strength). (SGE)

    Reactions should be assessed by a trained observer between 48
       and 72 hours after injection. Reactions of 5 mm or greater
       induration should be considered positive in persons with HIV
       infection, regardless of prior BCG vaccination. (SGE)

    Two of the following three antigens can be used for anergy
       testing: candida, mumps, or tetanus toxoid. Any degree of
       induration observed in response to intradermal injection of
       these antigens constitutes a positive reaction and indicates
       that the individual is not anergic. (SGE)

    Chest x-rays should be obtained to exclude the presence of
       active pulmonary TB in all HIV-infected individuals who are
       PPD-positive, anergic, or have symptoms suggestive of TB. (SGE)

    If the chest x-ray reveals any abnormality, multiple sputum
       smears and cultures should be performed. (SGE)

    If a sputum smear is positive, the patient should be started on
       anti-TB therapy immediately, pending culture results. Acid-fast
       bacillus (AFB) isolation should be initiated promptly if the
       patient is coughing. If the sputum smears are negative and if
       there is no other etiology for the abnormal chest x-ray,
       bronchoscopy should be performed and empiric anti-TB therapy
       should be initiated, pending the results of the mycobacterial
       culture. AFB isolation should be maintained until the diagnosis
       is confirmed by smear or culture. (SGE)

    In many of these clinical situations, diagnostic evaluation and
       management will need to be individualized. Consultation with an
       infectious disease or pulmonary specialist may be necessary.
       (SGE)

       Preventive Therapy

       Preventive therapy for TB should proceed according to the
       following protocol: (1) isoniazid (INH) preventive therapy
       should be initiated and continued for 12 months in all
       HIV-infected individuals who have a positive PPD test but do
       not have active disease, regardless of their age; (2)
       preventive therapy should be strongly considered for anergic
       patients who are known contacts of patients with TB and for
       anergic patients belonging to groups in which the prevalence of
       TB infection is 10 percent or higher. Such individuals include
       injection drug users, prisoners, homeless persons, persons
       living in congregate housing, migrant laborers, and persons
       born in countries where rates of TB are high. (SGE)

    Clinicians should consider factors specific to their geographic
       areas, including the incidence and prevalence of TB infection,
       when considering the decision to start preventive therapy.
       (SGE)

    In persons with HIV who are exposed to drug-resistant strains
       of M. tuberculosis, an alternative preventive therapy should be
       considered. Consultation should be sought with a pulmonary or
       infectious disease specialist. (SGE)

    The presence of AFB on sputum smear should prompt immediate
       empiric anti-TB therapy tailored to community
       drug-susceptibility patterns, pending final determination of
       drug susceptibility testing. (SGE)

       Pregnant Women

    The evaluation and management of M. tuberculosis infection in
       pregnant women should be performed as described in the
       recommendations above. Preventive INH therapy is not
       contraindicated in pregnant women and should be initiated
       according to these recommendations. (SGE)

    In asymptomatic women, chest x-ray should be performed only
       after the first trimester, and a lead apron shield should be
       used. In women with symptoms that suggest TB, x-rays should be
       performed irrespective of stage of pregnancy. A lead apron
       shield should be used. (SGE)

       Improving Adherence to Regimens of Preventive Therapy for TB

       The failure of patients to complete treatment of their M.
       tuberculosis infection is a common and serious concern because
       these patients are at increased risk that the infection will
       progress to the disease, tuberculosis. Additionally, these
       individuals may infect others and may develop drug-resistant
       strains of M. tuberculosis. Specific recommendations include:

    TB prophylaxis and treatment regimens should be closely
       monitored by health care providers to ensure completion of the
       entire course of therapy. (SGE)

    Providers should educate their patients about the importance of
       completing the full course of anti-TB therapy, and should
       recommend the simplest appropriate regimen. (EO)

    Case management and directly observed therapy should be used
       when needed to ensure successful completion of therapy. (EO)

       Testing and Treatment for Syphilis

       The incidence of HIV infection and syphilis have both increased
       dramatically in the last 10 years, and co-infection is not
       uncommon. It is crucial to know whether both are present
       because HIV infection may alter the natural history, laboratory
       diagnosis, and patient's response to syphilis therapy.

       Sexually experienced adolescents have a high rate of sexually
       transmitted diseases (STDs). A sexual history, screening pelvic
       or genital examination, and laboratory assessment are indicated
       for all adolescents who have had sexual intercourse, including
       those who are asymptomatic.

       Recommendations for the assessment and treatment of syphilis in
       HIV-infected patients are summarized in Algorithm 5. Specific
       recommendations include:

       Screening and Diagnosis

    All HIV-infected and sexually experienced adults and
       adolescents should be evaluated for syphilis. (SGE)

    Initial serologic screening for current or past syphilis should
       be performed with nontreponemal tests (i.e., the rapid plasma
       reagin [RPR] or the Venereal Disease Laboratories [VDRL] test).
       (SGE)

    All reactive nontreponemal tests should be followed by a
       specific treponemal test (i.e., the microhemagglutination assay
       for Treponema pallidum [MHA-TP] or the fluorescent treponemal
       antibody absorption [FTA-ABS] test). (SGE)

    In patients with clinical findings suggestive of syphilis who
       have nonreactive nontreponemal tests, the serum should be
       diluted to overcome the possibility that the high antibody
       levels have produced a prozone phenomenon. (SGE)

    In patients with primary syphilis, both nontreponemal and
       treponemal serologic tests may be nonreactive. If primary
       syphilis is suspected, dark-field microscopy and direct
       fluorescent antibody staining for T. pallidum (DFA-TP) from a
       scraping of suspected lesions should be performed. (SGE)

    If a dark-field examination cannot be done and primary syphilis
       is suspected, empiric treatment should be instituted. (SGE)

    Evaluation of the cerebrospinal fluid (CSF) for evidence of
       neurosyphilis may be prudent for all HIV-infected individuals
       with positive treponemal serologies. (SGE)

    HIV-infected pregnant women should be screened for syphilis
       with a nontreponemal test (RPR or VDRL) at entry into prenatal
       care, during the third trimester, at delivery, and at any time
       when they have been exposed to or present with symptoms or
       signs of an STD. (SGE)

       Management

       CSF evaluation should be discussed with and encouraged in all
       HIV-infected individuals with primary syphilis. It should be
       recommended to all HIV-infected patients with secondary
       syphilis, latent syphilis, or infection of unknown duration.
       (EO)

    If neurosyphilis is excluded, primary, secondary, early latent,
       and late latent syphilis, as well as infection of unknown
       duration, should be treated with three weekly doses of
       intramuscular benzathine penicillin, 2.4 million units. (SGE)

    HIV-infected individuals with abnormal CSF findings (presence
       of cells, increased protein, or positive VDRL test results)
       should be treated with a regimen effective against
       neurosyphilis: intravenous (IV) aqueous penicillin, 2 to 4
       million units every 4 hours for 10 to 14 days. (SGE)

    Treatment for presumptive neurosyphilis should be encouraged
       when the CSF cannot be evaluated. (EO)

    Patients with syphilis and a reported reaction to penicillin
       should be referred to an allergist or infectious disease
       specialist. (EO)

    All HIV-infected individuals should have a nontreponemal
       serologic test for syphilis performed at least annually. In
       addition, serologic tests should be performed after exposure to
       or diagnosis of any STD. (EO)

    In HIV-infected individuals who have been diagnosed with and
       treated for syphilis, followup nontreponemal serologies should
       be performed at 1, 2, 3, 6, 9, and 12 months post-treatment and
       annually thereafter. The same test should be used each time,
       because titers are not comparable between different
       nontreponemal tests. (EO)

    HIV-infected individuals diagnosed with syphilis should be
       evaluated for other STDs and substance use and should be
       managed accordingly. The diagnosis of syphilis or other STDs in
       HIV-infected individuals should alert the provider to counsel
       the patient on the importance of safe-sex practices. (EO).

    Treatment and followup of syphilis are the same for pregnant
       women as for nonpregnant adults. To reliably prevent congenital
       syphilis, penicillin therapy must be completed at least 4 weeks
       prior to delivery. All infants born to women with syphilis
       should be assessed for congenital syphilis and managed as
       appropriate. (SPE)

       Oral Examinations

       HIV-infected patients experience several unique oral
       conditions, including frequent oral lesions and in some
       patients, unusually rapid and destructive periodontal disease.
       As a result, special attention should be paid to their routine
       and specialized oral care. Oral lesions, in particular, are
       important because they may provide the only early indication of
       HIV infection, and they are key in classifying the stage of HIV
       disease. Recommendations for oral care include the following:

    Discuss with patients the importance of oral care, including
       descriptions of common HIV-related oral lesions and associated
       symptoms.

    Perform an oral examination during every physical examination
       (EO); all oral mucosal surfaces should be carefully examined.
       (SGE)

    Recommend that patients have twice-yearly dental examinations;
       if oral lesions or other problems appear, dental followup
       should be more frequent. (SGE)

    Primary care providers and dentists should be trained to
       identify and treat oral lesions associated with HIV infection.
       (EO)

       Eye Examinations

       While there are a number of ocular complications associated
       with HIV disease, they generally occur at a late stage of the
       disease. Cytomegalovirus retinitis (CMV retinitis) is the most
       common opportunistic infection associated with visual loss in
       HIV infection. Providers should take the following steps
       regarding eye care:

    Take a careful history of any visual disturbances and perform
       an eye examination, including funduscopy, during the patient's
       routine visits. Educate the patient about CMV retinitis and
       visual disturbances (e.g., blurring or vision loss) and the
       importance of monitoring visual symptoms to maximize early
       identification. (EO)

    Recommend to patients that they be examined by a qualified eye
       doctor according to the following schedule: every 3 to 5 years
       at ages 20 to 39; every 2 to 4 years at ages 40 to 64; every 1
       to 2 years at ages 65 and over. More frequent examinations will
       be necessary if problems develop. (EO)

    Refer patients with any visual symptoms suggestive of CMV to an
       ophthalmologist for confirmation of diagnosis. (SGE)

       Pap Smears

       With the increasing impact of the HIV epidemic on women, the
       evaluation of HIV-associated gynecologic conditions and the
       provision of appropriate gynecologic care for women with HIV
       infection have become important areas of concern for the
       primary care provider.

       Evidence shows a higher prevalence of Pap smear, vaginal, and
       cervical abnormalities among HIV-infected women compared with
       uninfected women. In addition, cervical abnormalities are
       likely to be more severe and may progress more rapidly in women
       with HIV infection. Regular gynecologic examinations, including
       a Pap smear, are therefore an integral component of primary
       care for these patients. Recommendations on Pap smears for
       women with early HIV infection are outlined in Algorithm 6 and
       in the chart that follows.

    A Pap smear should be done as part of the initial gynecologic
       examination in all women with HIV infection. For pregnant
       women, Pap smears should be performed at entry into prenatal
       care. Women who have not received prenatal care should have a
       Pap smear before being discharged from the hospital following
       delivery. (SGE)

       ________________________________________

       Suggested classification of squamous epithelial cell cytologic
       changes

       1. Atypical squamous cells of undetermined significance
          (specify recommended followup and/or type of further
          investigation).

       2. Squamous intraepithelial lesions (SILs) [comment on presence
          or absence of cellular changes consistent with human
          papilloma virus (HPV) infection]:

          Low-grade SIL, encompassing:
          Cellular changes consistent with HPV infection
          Mild dysplasia/CIN 1
          High-grade SIL, encompassing:
          Moderate dysplasia/CIN 2
          Severe dysplasia/CIN 3
          Carcinoma in situ/CIN 3

       3. Squamous carcinoma.
       _________________
       Summarized from abstract presented at the Workshop on
       Terminology and Classification of Vaginal Cytology, National
       Cancer Institute, December 1988.

       ___________________________________________

    Pap smears should be repeated twice in the first year; annually
       when the initial Pap smear is normal; every 6 months when there
       is a history of human papilloma virus (HPV) infection, previous
       Pap smear showing squamous intraepithelial lesion (SIL), or
       symptomatic HIV infection; after treatment of the underlying
       cause of an inflammation; or if no endocervical cells are seen.
       (SGE)

    All women, including those who are pregnant, should be referred
       to a trained clinician for colposcopy when: the Pap smear
       indicates atypical cells of undetermined significance; the Pap
       smear demonstrates either low- or high-grade SILs or carcinoma;
       there is a history of untreated SIL. (SGE)

       Pregnancy Counseling

       Counseling HIV-infected women with regard to reproductive
       issues and options should be a part of primary care practice.
       The counseling must focus on the health outcomes that might be
       expected as a result of any choice, for the mother as well as
       for the infant. These outcomes include the possible effects of
       pregnancy on the mother's health and the progression of her HIV
       infection; the issues pregnancy raises with regard to
       enrollment in clinical trials and access to new agents; the
       effect of HIV infection on birth outcome; the risk of HIV
       transmission from mother to infant; the prognosis of HIV
       infection in infants; and issues related to the care of
       children who have lost their parents.

       Pregnancy counseling remains challenging because evidence shows
       that a woman's decision to become pregnant or to continue or
       terminate a pregnancy is not related in a straightforward way
       to the woman's HIV status and possible HIV-related outcomes.
       Specific recommendations include:

    Conduct contraceptive, preconceptional, and prenatal counseling
       for HIV-infected patients in a nondirective manner, with the
       focus on the woman. Listen more than talk. (SGE)

    Assess the psychological state of the patient and provide the
       most recent information in language she will understand, on
       possible effects of HIV infection and pregnancy on each other,
       on her current health status, transmission rates to the fetus
       and to sexual partners, and the need for contingency plans for
       future care of children. (SGE)

    Include maternal characteristics such as age, attitudes and
       beliefs, general health status, and pregnancy history in
       contraception and pregnancy counseling for HIV-infected
       patients. (SGE)

    Inform the patient that at present there is no direct evidence
       of a deleterious effect of pregnancy and childbirth on the
       course of early HIV infection and no consistent evidence of
       adverse birth outcomes in infants of women with early HIV
       infection. (SGE)

    Explain that breast-feeding is not recommended for HIV-infected
       mothers in the United States because of the risk of
       transmission. (SGE)

    Inform pregnant patients that the risk of perinatal HIV
       transmission ranges from 13 to 39 percent. (SPE)

    During counseling, discuss the long-term implications of
       pregnancy decisions on the family and encourage the patient to
       discuss these issues with significant others. (EO)

    Respect the woman's decision regarding conception and
       continuation or termination of pregnancy. (EO)

       Caring for Adolescents with Early HIV Infection

       HIV infection is spreading rapidly in the adolescent
       population. There are approximately 30,000 HIV-infected
       adolescents in the United States today. Since 1988, AIDS has
       been the sixth leading cause of death among young persons 15 to
       24 years of age in the United States. Caring for adolescents
       with early HIV infection presents a unique set of issues:
       differences in the epidemiology of HIV infection among youth;
       variable laws and practices regarding consent and
       confidentiality for minors under the age of 18; special
       barriers to receiving HIV care; lack of availability of
       age-specific clinical services; special features of the
       progression of HIV infection during adolescence; limited
       standards for routine management of HIV infected youth;
       difficulties in assuring adolescents' participation in
       research, including clinical trials; and lack of dissemination
       of effective models for engaging and retaining youth in HIV
       care and prevention efforts.

       To adequately care for HIV-infected youth, primary care
       providers must address the barriers that prevent adolescents
       from accessing care, including payment, consent, and
       confidentiality. Providers also must be able to offer the
       appropriate range of laboratory tests, including Pap smears and
       STD screening tests.

       Issues related to the care of adolescents are discussed in this
       section. In addition, more specific recommendations for
       adolescent HIV care are integrated throughout this Quick
       Reference Guide. Recommended drugs and dosages specific to
       adolescents are detailed in Tables 1, 2, and 3 (pages 21-24).

       Age-specific counseling at the time of HIV testing is the first
       step in appropriate early care for HIV-infected adolescents.
       For all adolescents, support at the time of test result
       notification in the form of a supportive adult (parent,
       guardian, or other) is preferable.

       Clinical assessment and care are different for adolescents than
       for young children or adults. History-taking, physical
       examination, and laboratory assessment of HIV-infected
       adolescents should be conducted and interpreted within the
       context of age-specific issues. An appropriate history should
       include details about sexual and drug use practices, including
       age of initiation, same and opposite sex experiences, sexual
       identity, and use of condoms or other barrier methods.
       Psychosocial assessment should include details of living
       situation, peer group associations, and school and work
       activities, as well as an assessment of cognitive development
       and psychiatric history (with attention to suicidal ideation).

       The physical examination and staging of HIV infection should
       take into account the marked changes in body size and
       composition and organ function that occur during puberty. When
       assessing development during adolescence, use of the Sexual
       Maturity Rating Scale of Tanner and Whitehouse is a more
       reliable indicator of pubertal development than is chronologic
       age.

       Progression of HIV infection in adolescents may differ from
       adults. For example, HIV wasting is defined by weight loss in
       adults, but during puberty--when height and weight should be
       increasing dramatically--wasting should be characterized as a
       failure to gain weight. Because adolescents have the highest
       rates of STDs of any age group, a screening pelvic or genital
       examination and laboratory assessment are indicated even for
       asymptomatic adolescents who have had sexual intercourse.

       Antiretroviral treatment should begin with pediatric dose
       schedules for adolescents who are Tanner stage I or II; adult
       dose schedules should be used for adolescents who are Tanner
       stage IV or V. Tanner stage III youths should be monitored
       particularly closely, as this is the time of most rapid growth.
       Pubertal changes in body composition and organ function may
       affect drug distribution and metabolism, thereby necessitating
       changes in drug dose and interval of administration.

       Evaluation and Management of HIV-Infected Infants and Children

       Currently, there are an estimated 15,000 to 20,000 HIV-infected
       infants and children in the United States. Since the screening
       of blood products began in 1985, perinatal HIV transmission has
       accounted for 85 percent of all AIDS cases in children under
       age 13.

       Primary care providers can do much to care for these patients,
       including identifying at-risk infants and HIV-infected
       children; performing routine counseling and diagnostic tests
       for HIV infection; monitoring clinical and immunologic status;
       providing general pediatric care, including immunizations; and
       linking families to case management and additional counseling.

       Diagnosis of HIV Infection in Infants and Children

       Because the interval between infection, development of AIDS,
       and mortality is compressed in infants and children, the need
       for early diagnosis of HIV infection is crucial. Diagnostic
       testing of infants and children of HIV-infected mothers should
       be incorporated into the schedule of routine pediatric care and
       immunizations.

       Evidence of infants born to HIV-infected mothers shows that
       most have clinical or immunologic abnormalities by 6 months of
       age. The first chart on page 19 presents the tests and
       timetables for determining HIV status in infants. The common
       clinical manifestations and HIV-associated conditions in
       infants and children are listed in the second chart. Because of
       its
        ____________________________________________

       Chart: Diagnosis of infection in HIV-exposed infants
                    Not available on disk - see attached
        ____________________________________________

       HIV-associated conditions in pediatric HIV infection

       Failure to thrive
       Generalized lymphadenopathy
       Hepatomegaly
       Splenomegaly
       Persistent oral candidiasis
       Parotitis
       Recurrent or chronic diarrhea
       Encephalopathy
       Lymphoid interstitial pneumonitis (LIP)
       Hepatitis
       Cardiomyopathy
       Nephropathy
       Recurrent bacterial infections
       Opportunistic infections (recurrent viral infections [herpes
       simplex, herpes zoster], fungal, parasitic)
       Malignancies (lymphoma)

       __________________________________________

       complexity, laboratory diagnosis of HIV-infected newborns and
       infants and evaluation of HIV-related central nervous system
       (CNS) symptoms should be done in consultation with a pediatric
       HIV specialist. Specific recommendations include:

    All infants born to HIV-infected mothers should be monitored to
       determine HIV status. (SPE)

    In the HIV-exposed infant under 18 months of age, virus culture
       or polymerase chain reaction (PCR) are the preferred methods
       for diagnosis of HIV infection. If these tests are not
       available, P24 antigen assays should be used. (SPE)

    One or more of these HIV- specific tests should be done as soon
       as possible after the infant has reached 1 month of age. If
       negative, testing should be repeated between 3 and 6 months of
       age. (SPE)

    Infants with negative diagnostic tests at 6 months of age
       should have an HIV antibody test (enzyme-linked immunosorbent
       assay, ELISA) performed at 15 and 18 months of age to document
       HIV infection status. (SPE)

    In the child over 18 months of age, testing for antibody to HIV
       using the standard ELISA test with an approved confirmatory
       test is sufficient for diagnosis of HIV. (SPE)

       Monitoring CD4 Lymphocytes and Initiating PCP Prophylaxis and
       Antiretroviral Therapy

       HIV infection has more adverse effects on the developing immune
       systems of infants and children than it does on the mature
       immune systems of older individuals, thus the onset of clinical
       symptoms and the progression of disease are more rapid in this
       group. It is, therefore, crucial to use a marker for immune
       status in younger patients so that preventive therapies can be
       instituted while they still can be effective. Algorithm 7
       summarizes pertinent recommendations, and Tables 1, 2, and 3
       list the common antiretroviral, PCP, and TB drugs used for
       younger age groups, and their dosages and adverse effects.
       Specific recommendations include:

    CD4 counts and percentages should be obtained in all infants
       born to HIV-seropositive mothers at 1, 3, and 6 months of age,
       and then at 3-month intervals until the HIV status of the child
       is known. (EO)

    Thereafter, CD4 counts and percentages should be monitored at
       3- to 6-month intervals in children proven to be HIV-infected.
       (EO)

    PCP prophylaxis should be initiated if the CD4 cell count falls
       below age-adjusted normal values, if the percentage of CD4
       cells is 20 percent or lower, or after the patient has had an
       episode of PCP, regardless of CD4 count. (SGE)

    Emerging data suggest that PCP prophylaxis should be initiated
       in at-risk and infected infants 1 month to 1 year of age,
       regardless of CD4 count or percentage. The drug of choice for
       prophylaxis is trimethoprim-sulfamethoxazole, or TMP-SMX. (SGE)

    Antiretroviral therapy should be initiated for (a) all infants
       and children with symptomatic HIV infection (SGE); (b) any
       HIV-infected infant or child whose CD4 count falls below the
       following age-adjusted thresholds: less than 1,750 cells/■l for
       infants birth to 12 months; less than 1000 cells/■l for infants
       12 to 24 months; less than 750 cells/■l for children between 2
       and 6 years of age; and less than 500 cells/■l for children
       over 6 years of age; and (c) any HIV-infected infant less than
       1 year of age with a CD4 percentage of 30 or less; any child
       between 1 and 2 years with a CD4 percentage of 25 or less; and
       children of all other ages through adolescence with a CD4
       percentage of 20 or less (EO).

       Neurologic Testing

       HIV infection in infants and children results in a wide
       spectrum and a high incidence of neurologic disease. In
       children with perinatal HIV infection, clinical signs of
       neurologic dysfunction may appear as early as 2 months and as
       late as 5 years of age. This neurologic dysfunction is caused
       either directly or indirectly by a primary HIV infection of the
       brain and is most commonly manifested in impaired brain growth;
       motor dysfunction; attention and memory difficulties; loss or
       plateau of previously acquired milestones; and cognitive
       impairment.

       Algorithm 8 outlines the steps in evaluating neurologic status
       of infants and children with early HIV infection. Specific
       recommendations include:

    A neurologic examination, including an age-related
       developmental assessment, should be performed on all
       HIV-exposed infants and HIV-infected infants and children at
       the initial assessment. A neurologic examination should be
       performed at each clinical visit, and an age-related
       developmental assessment should be done every 3 months for the
       first 24 months of life and every 6 months thereafter. (EO)

    Baseline computerized tomographic (CT) scan or magnetic
       resonance imaging (MRI) is recommended at the time of diagnosis
       of HIV infection in infants and children. If CNS symptoms
       subsequently occur, neuroimaging studies should be repeated and
       cerebrospinal fluid obtained for analysis. (EO)

    Serial CT or MRI scans are not indicated for the routine
       evaluation of HIV-infected infants and children who do not have
       CNS symptoms. (EO)

    After exclusion of other diagnoses, infants and children who
       have primary HIV CNS disease should be treated with
       antiretroviral therapy and referred to a pediatric neurologist,
       if available, or a specialist in HIV care. (SGE)

    Support and rehabilitation services, such as nutritional
       supplementation; physical, occupational, or speech therapies;
       and early intervention programs should be part of the
       comprehensive management of these patients. (EO)

       Case Management for Persons Living with HIV

       Case management for persons with HIV infection is a mechanism
       to facilitate provision of comprehensive health and mental
       health care and social support services. One of its objectives
       is to empower patients, family members, and significant others.
       It includes identifying those who need services, assessing
       their specific needs, developing a written care plan,
       implementing and monitoring the plan, reassessing and updating
       the plan as necessary, and terminating the plan when
       appropriate.

       In the early stages of HIV infection, case management centers
       around the provision of social services, such as housing and
       financial assistance. As the infection progresses, the focus
       shifts to a greater emphasis on the provision of medical
       services. Case management services can be delivered in a number
       of different settings, such as physician offices, community
       health clinics or hospitals, rehabilitation facilities, or
       within community-based organizations. Specific recommendations
       are:

    All primary care providers should be knowledgeable about the
       uses of case management and should develop referral mechanisms
       to case-management services in their community (see listing of
       national and State resources on pages 35 and 36 of this guide).
       Methods for accomplishing this include providing continuing
       education and training; contracting with a local or regional
       case-management system; or employing a case manager in the
       primary care setting. (EO)

    Case-management services should include intake; assessment of
       patient needs; development, implementation, and monitoring of a
       case-management plan; and periodic assessments. (EO)

    Case-management services should be comprehensive and formalized
       in a written care plan that sets forth which services are
       required, who will provide them, and within what time frame.
       The patient or his or her parent or guardian should be able to
       select the specific services required at a given time. (EO)

    Case-management programs should be directed by individuals
       knowledgeable about the clinical nature of HIV infection and
       issues affecting service delivery. (EO)

    Minimum qualifications for a case manager include a working
       knowledge of the disease and/or illnesses of their patients, as
       reported in medical and nursing assessments; knowledge of and
       contact with services in immediate and neighboring communities
       as well as with health care, social services, and public
       entitlement programs; resourcefulness and creativity in
       accessing required services; the ability to interact
       effectively with clients and multiple providers in all
       settings; and the ability to maintain a spirit of hope and to
       empathize with patients and their loved ones. (EO)

       Conclusion

       As the number of HIV-infected persons increases throughout this
       decade, the need for well-informed health care providers also
       increases. The changing geographic distribution of the disease,
       with HIV infection no longer concentrated in only a handful of
       cities but spread across the country, places increasing demands
       on delivery sites and providers formerly unaffected by the
       epidemic. Providers will need to acquire new information and
       skills, and public and private policymakers will need to
       develop new systems to meet these challenges.

       This "Quick Reference Guide" and the "Guideline" from which it
       is drawn present recommendations for early identification and
       management of HIV infection in infants, children, adolescents,
       and adults. Early care for HIV-infected individuals can have a
       major effect on their quality of life and, with appropriate
       patient education, help stem the spread of the disease.

       Tables 1, 2, and 3 and Algorithms 1 through 8
       not available on disk -- see attached

       Sources of HIV information

       General information:

       English: 800-342-AIDS (2437)
       Spanish: 800-344-7432
       TDD Service for the Deaf: 800-243-7889

       General information for health care providers:

       HIV Telephone Consultation Service: 800-933-3413

       State hotlines:

       For information about HIV-specific resources and counseling and
       testing services, call your State AIDS hotline:

       Alabama                  800-228-0469
       Alaska                   800-478-2437
       Arizona                  800-548-4695
       Arkansas                 501-661-2133
       California (No.)         800-367-2437
       California (So.)         800-922-2437
       Colorado                 800-252-2437
       Connecticut              800-342-2437
       Delaware                 800-422-0429
       District of Columbia     202-332-2437
       Florida                  800-352-2437
       Georgia                  800-551-2728
       Hawaii                   800-922-1313
       Idaho                    208-345-2277
       Illinois                 800-243-2437
       Indiana                  800-848-2437
       Iowa                     800-445-2437
       Kansas                   800-232-0040
       Kentucky                 800-654-2437
       Louisiana                800-922-4379
       Maine                    800-851-2437
       Maryland                 800-638-6252
       Massachusetts            800-235-2331
       Michigan                 800-827-2437
       Minnesota                800-248-2437
       Mississippi              800-537-0851
       Missouri                 800-533-2437
       Montana                  800-233-6668
       Nebraska                 800-782-2437
       Nevada                   800-842-2437
       New Hampshire            800-324-2437
       New Jersey               800-624-2377
       New Mexico               800-545-2437
       New York                 800-541-2437
       North Carolina           800-733-7301
       North Dakota             800-472-2180
       Ohio                     800-332-2437
       Oklahoma                 800-535-2437
       Oregon                   800-777-2437
       Pennsylvania             800-662-6080
       Puerto Rico              800-765-1010
       Rhode Island             800-726-3010
       South Carolina           800-322-2437
       South Dakota             800-592-1861
       Tennessee                800-525-2437
       Texas                    800-299-2437
       Utah                     800-366-2437
       Vermont                  800-882-2437
       Virginia                 800-533-4148
       Virgin Islands           809-773-2437
       Washington               800-272-2437
       West Virginia            800-642-8244
       Wisconsin                800-334-2437
       Wyoming                  800-327-3577

       For HIV/AIDS treatment information, call:

       The American Foundation for AIDS Research
       800-39AMFAR (392-6327)

       AIDS Treatment Data Network
       212-268-4196

       AIDS Treatment News
       800-TREAT 2 (873-2812)

       For information about AIDS/HIV clinical trials conducted by
       National Institutes of Health and Food and Drug
       Administration-approved efficacy trials, call:

       AIDS Clinical Trials Information Service (ACTIS)
       800-TRIALS-A (874-2572)

       To locate a physician, call your local or State Medical Society

       For more information about HIV infection, call:

       Drug Abuse Hotline  800-662-HELP (4357)
       Pediatric and Pregnancy AIDS Hotline [phone]
       National Hemophilia Foundation 212-219-8180
       Hemophilia and AIDS/HIV Network for Dissemination of Information
       (HANDI)   800-42-HANDI (424-2634)
       National Pediatric HIV Resource Center 800-362-0071
       National Association of People with AIDS 202-898-0414
       Teens Teaching AIDS Prevention Program (TTAPP) National Hotline:
       800-234-TEEN (8336)

       Note: This is not an all-inclusive list. For other sources of
       information, contact your State HIV hotline listed on page 35.

       Abstract

       This Quick Reference Guide for Clinicians contains
       highlights from the Clinical Practice Guideline on Evaluation and
       Management of Early HIV Infection, which was developed by a
       private-sector panel of health care providers and consumers.
       Selected aspects of evaluating and managing patients, both adults
       and children, who are in the early stages of human
       immunodeficiency virus infection are presented. Topics covered
       include disclosure of HIV status, monitoring of CD4 lymphocyte
       counts, prevention of Pneumocystis carinii pneumonia and
       infection with Mycobacterium tuberculosis, initiation of
       antiretroviral therapy, treatment of syphilis, eye and oral care,
       performance of Papanicolaou smears, diagnosis of HIV infection in
       infants and children, preventive therapy for PCP and assessment
       of neurologic problems in HIV-infected children, pregnancy
       counseling, and development of a comprehensive case management
       system. Algorithms are included that show the sequence of events
       related to evaluating and managing early HIV infection in adults
       and children, as well as drug dosing tables for antiretroviral,
       PCP, and M. tuberculosis therapies.

       This document is in the public domain and may be used and
       reprinted without special permission. AHCPR would appreciate
       citation as to source; the suggested format is:

       El-Sadr W, Oleske JM, Agins BD et al. Managing Early HIV
       Infection: Quick Reference Guide for Clinicians. AHCPR
       Publication No. 94-0573. Rockville, MD: Agency for Health Care
       Policy and Research, Public Health Service, U.S. Department of
       Health and Human Services, January 1994.

       U.S. Department of Health and Human Services
       Public Health Service
       Agency for Health Care Policy and Research
       Executive Office Center, Suite 501
       2101 East Jefferson Street
       Rockville, MD 20852

       AHCPR Publication No. 94-0573
       January 1994