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1–34 | Clinical Manual for Management of the HIV-Infected Adult/2006 A: Assessment and Plan Patients with primary HIV infection will need additional medical evaluation, baseline laboratory testing, and intensive support, counseling, and education about HIV infection. See chapters Initial History, Initial Physical Examination, and Initial and Interim Laboratory and Other Tests for detailed information on the initial evaluation of HIV-infected patients. Laboratory The initial laboratory work should include the following: ♦ ♦ ♦ The CD4 count and HIV viral load should be checked on 2 occasions within several weeks. A baseline HIV genotype test should be obtained for all patients with primary HIV infection, even those who do not choose to start antiretroviral treatment (ART). In some cities in the United States and Europe, up to 15-20% of individuals infected in recent years have acquired HIV virus strains with mutations that confer resistance to antiretroviral medications. These resistance mutations may be identified by early resistance testing, but later may not be detectable. (See chapter Resistance Testing.) The HIV antibody test should be repeated in 4-6 weeks to document the HIV status of patients who are presumed to have primary HIV infection. Treatment It is reasonable to consider starting combination ART in patients with acute HIV infection, because some limited evidence suggests that treatment initiated during primary HIV infection may preserve HIV-specific immune function that would otherwise be lost as the infection progresses. However, it is not yet clear whether initiating early treatment yields long-term immunologic, virologic, or clinical benefits. The potential advantages of ART for primary infection must be weighed against the possibility of short- and long-term toxicities, the possibility of developing drug resistance, and the adherence challenges associated with starting antiretrovirals quickly in newly diagnosed patients. These issues are complex, and consultation with an HIV expert or referral to a clinical trial is recommended. For patients who choose to start therapy during primary HIV infection, the choice of agents and the monitoring of patients on treatment are similar to those in the treatment of chronic HIV infection (see chapter Antiretroviral Therapy). The initial goal of therapy in primary HIV infection is to suppress the HIV viral load to undetectable levels. Clinical trials across the country currently are recruiting individuals to evaluate both the natural history of primary HIV infection and the possible benefits of treatment of acute HIV infection. Information on clinical studies of primary HIV may be obtained through the AIDS Clinical Trials Information Service (ACTIS) on its Web site at http://www.aidsinfo.nih. gov/clinicaltrials or by telephone at 800-HIV-0440. Issues concerning the possible treatment of primary HIV infection also are reviewed in the U.S. Department of Health and Human Services Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patient Education Patients with primary HIV infection need support and counseling, as do all newly diagnosed patients. Intensive education about HIV infection, the course of disease, prognosis, and the risks and benefits of ART must be undertaken. Counseling about safer sex and drug injection techniques, as indicated, is especially important for these patients because they may have ongoing highrisk behaviors for HIV transmission and because they may be highly infectious during the primary infection period. (See chapter Preventing HIV Transmission / Prevention with Positives for more information about patient support and counseling in these areas.) References ♦ ♦ ♦ ♦ Daar ES, Little, S, et al. Diagnosis of primary HIV- 1 infection. Los Angeles County Primary HIV Infection Recruitment Network. Ann Intern Med. 2001 Jan 2;134(1):25-9. Schacker T, Collier AC, Hughes J, et al. Clinical and epidemiologic features of primary HIV infection. Ann Intern Med. 1996 Aug 15;125(4):257-64. Smith DE, Walker BD, Cooper DA, et al. Is antiretroviral treatment of primary HIV infection clinically justified on the basis of current evidence? AIDS. 2004 Mar 26;18(5):709-18. U.S. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV- 1-Infected Adults and Adolescents. October 10, 2006. Available online at aidsinfo.nih.gov/Guidelines/ GuidelineDetail.aspx?GuidelineID=7. Accessed July 7, 2007.
Rapid HIV Testing Background It is estimated that as many as 300,000 individuals in the United States are unaware that they have HIV infection. It is also estimated that about 25% of these individuals account for approximately 55% of the 40,000 new infections occurring in the United States each year. Studies have shown that once individuals learn about their HIV infection, they substantially reduce their high-risk sexual behaviors. However, even when people are tested for HIV with standard HIV tests, many do not return to obtain the results. With rapid HIV testing, clients can receive their results during the same visit. A rapid test can allow referrals for urgent treatment, such as in pregnant women, as well as non urgent referrals to engage patients in medical care. Rapid testing also provides immediate information for making clinical decisions, such as whether to offer postexposure prophylaxis. Clients and Settings for Rapid Testing Rapid HIV testing is recommended for settings in which the availability of rapid HIV test results would influence medical care immediately, or HIV prevalence is high but clients are not likely to return for the results of HIV tests. These settings include labor and delivery settings (to allow intervention to reduce the should be available within 1 hour. Table 1. FDA-Approved Rapid HIV Antibody Screening Tests Test Specimen Type CLIA Category OraQuick Advance Rapid HIV-1/2 Antibody Test Uni-Gold Recombigen HIV Whole blood (finger stick or venipuncture) Sensitivity (95% CI*) Section 1—Testing and Assessment | 1–35 risk of perinatal HIV transmission in women with undocumented or unknown HIV status) as well as hospital emergency departments, urgent care and acute care clinics, sexually transmitted disease clinics, drug treatment clinics, and clinical care or testing sites. Rapid HIV testing also is available or being implemented in employee health departments at many hospitals as part of evaluation for and provision of postexposure prophylaxis. Rapid HIV Tests The U.S. Food and Drug Administration has approved 4 rapid tests for use in the United States (Table 1). Federal regulations under the Clinical Laboratory Improvement Amendments (CLIA) program categorize tests as waived, moderate complexity, or high complexity. Two rapid tests are approved as CLIAwaived tests, meaning that they may be done at the point of care after appropriate staff training and with procedures in place to insure quality control. These tests use whole blood or oral fluid and require a few simple steps to perform. Other rapid tests are “non waived” tests and must be performed in laboratories. Results for rapid tests done at the point of care are available in less than 30 minutes; results for those done in a laboratory Specificity (95% CI) Waived 99.6% (98.5-99.9) 100% (99.7-100) OraSure Technologies www.orasure.com Oral fluid Waived 99.3% (98.4-99.7) 99.8% (99.6-99.9) Plasma Moderate complexity Whole blood (finger stick or venipuncture) Serum/plasma Moderate complexity 99.6% (98.9-99.8) 99.9% (99.6-99.9) Manufacturer Approved for HIV-2 Detection Waived 100% (99.5-100) 99.7% (99.0-100) Trinity Biotech www.unigoldhiv.com 100% (99.5-100) 99.8% (99.3-100) Reveal G2 Serum Moderate 99.8% (99.2-100) 99.1% (98.8-99.4) MedMira Plasma complexity 99.8% (99.0-100) 98.6% (98.4-98.8) www.medmira.com MultiSpot HIV-1/HIV-2 Serum/plasma Moderate 100% (99.9-100) 99.9% (99.8-100) BioRad Laboratories HIV-2 complexity 100% (99.7-100) www.biorad.com Yes No No Yes, differentiates HIV-1 from HIV-2 Adapted from Health Research and Education Trust (HRET). FDA-Approved Rapid HIV Antibody Screening Tests, January 10, 2005. Prepared by Stanger K, Margolin F, Lampe M, et al. Available at: http://www.hret. org/hret/programs/hivtransmrpd.html. Accessed May 25, 2006.
Page 1 and 2: Clinical Manual for Management of t
Page 3 and 4: Table of Contents Clinical Manual f
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Page 7 and 8: Preface—About this Manual | Clini
Page 9: Previous Editions Atlanta Contribut
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Page 23 and 24: Initial Physical Examination Backgr
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Page 27 and 28: Initial and Interim Laboratory and
Page 29 and 30: Section 1—Testing and Assessment
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Page 53: References ♦ ♦ ♦ ♦ ♦ ♦
Page 67 and 68: Occupational Postexposure Prophylax
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Reducing Maternal-Infant HIV Transm
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Some states require written informe
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contraindicated during pregnancy be
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Section 3—Antiretroviral Therapy
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Nelfinavir (Viracept) Adequate drug
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Patient Education ♦ ♦ ♦ ♦
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Section 4—Complications of Antire
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♦ ♦ ♦ Toronto General Hospita
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Adverse Reactions to HIV Medication
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♦ ♦ ♦ ♦ ♦ Vital signs: No
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egimen, symptoms of fatigue could i
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Recreational Drugs and Antiretrovir
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Section 4—Complications of Antire
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LSD, Mescaline, Psilocin, and Methy
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Immune Reconstitution Syndrome Back
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A: Assessment In the appropriate cl
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♦ ♦ ♦ ♦ ♦ Navas E, Martin
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Eye Problems Background The immunos
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Fever Background Although fever may
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Headache Background Headache may ha
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Lymphadenopathy Background Lymphade
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Treatment Treatment will depend on
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Neurologic Symptoms Background The
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Pulmonary Symptoms Background Short
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Treatment Once the diagnosis is mad
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Candidiasis, Oral and Esophageal Ba
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Maintenance therapy Use caution whe
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Cervical Dysplasia Background Cervi
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Patient Education ♦ ♦ ♦ ♦ P
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Cryptosporidiosis Background Crypto
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Gonorrhea and Chlamydia Background
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Treatment of Gonorrhea Treatment op
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Hepatitis B Infection Background He
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♦ ♦ ♦ ♦ ♦ Some patients t
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Hepatitis C Infection Background He
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pregnancy. Ribavirin is teratogenic
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Herpes Simplex, Mucocutaneous Backg
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References ♦ ♦ ♦ ♦ ♦ Cent
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Kaposi Sarcoma Background Kaposi sa
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Treatment Treatment of KS is not co
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Molluscum Contagiosum Background Mo
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Mycobacterium avium Complex Backgro
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Table 1. Interactions between Rifab
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Mycobacterium tuberculosis: Treatme
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P: Plan Diagnostic Evaluation Durin
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Table 1. Regimens for Treatment of
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Rifabutin may be substituted for ri
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Non-Hodgkin Lymphoma Background Non
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Patient Education ♦ ♦ ♦ ♦ S
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Toxoplasmosis Background Toxoplasma
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♦ Atovaquone 1,500 mg orally twic
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Linear Gingival Erythema Background
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Background Necrotizing ulcerating p
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Oral Health Background Examination
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Maxillary Tori; Mandibular Tori S:
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Periodontal Disease Background The
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Oral Hairy Leukoplakia Background O
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Oral Ulceration Background Oral ulc
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Oral Warts Background Oral warts ar
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Anxiety Disorders Background Anxiet
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Patient Education ♦ ♦ Behaviora
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Insomnia Background Insomnia is a c
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Suicidal Ideation Background Transi
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Section 8—Neuropsychiatric Disord
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P: Plan ♦ ♦ ♦ ♦ ♦ Check t
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Correctional Settings Background Ca
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Adherence Adherence is one of the m
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Karnofsky Performance Scale Backgro
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