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3–24 | Clinical Manual for Management of the HIV-Infected Adult/2006 higher viral loads, ARV prophylaxis is a critical factor in reducing HIV transmission. One metaanalysis found that women with HIV RNA
contraindicated during pregnancy because the high levels of propylene glycol may not be metabolized well during pregnancy. The combination of didanosine (ddI) and stavudine (d4T) should be avoided unless no alternatives are available. Hydroxyurea, a drug previously thought to boost the response to ARVs, is a potent teratogen in various animal species and should not be used in the first trimester. Information on ARV toxicity during pregnancy should be consulted carefully before treatment choices are made. Table 1. Preclinical and Clinical Data Relevant to the Use of Antiretrovirals during Pregnancy Antiretroviral Drug FDA Pregnancy Category* Placental Passage (Newborn-to-Mother Drug Ratio) Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs) Section 3—Antiretroviral Therapy | 3–25 The USPHS Perinatal ARV Guidelines maintain information on each ARV drug, including preclinical and clinical data, pharmacokinetic and toxicity data, and recommendations regarding use in pregnancy. These guidelines are updated routinely as information is received (Tables 1-2). Of course, numerous other medications are contraindicated during pregnancy, and potential toxicity should be considered carefully before any medication is given to a pregnant woman. Long-Term Carcinogenicity Studies in Animals Abacavir (Ziagen, ABC) C Yes (rats) Positive: malignant and nonmalignant tumors of liver, thyroid in female rats, and preputial and clitoral gland of mice and rats Didanosine (Videx, ddI) B Yes (human) [0.5] Negative: no tumors, lifetime rodent study Emtricitabine (Emtriva, FTC) Teratogen Studies in Animals Positive: rodent anasarca and skeletal malformations at 1,000 mg/kg (35x human exposure) during organogenesis; not seen in rabbits Negative B Unknown Not completed Negative Lamivudine (Epivir, 3TC) C Yes (human) [~1.0] Negative: no tumors, lifetime rodent study Stavudine (Zerit, d4T) C Yes (rhesus monkey) [0.76] Positive: liver and bladder tumors in mice and rats, at very high-dose exposure Tenofovir DF (Viread) B Yes (rat and monkey) Positive: hepatic adenomas in female mice at high doses Zalcitabine (Hivid, ddC) C Yes (rhesus monkey) [0.30 - 0.50] Zidovudine†(Retrovir, AZT, ZDV) Negative Negative: but sternal bone calcium decreases in rodents Negative: but osteomalacia when given to juvenile animals at high doses Positive: thymic lymphomas in rodents Positive: hydrocephalus at high doses in rodents C Yes (human) [0.85] Positive: noninvasive vaginal epithelial tumors in rodents Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs) Delavirdine (Rescriptor) C Unknown Positive: hepatocellular adenomas and carcinomas in male and female mice but not rats; bladder tumors in male mice Efavirenz (Sustiva) D Yes (cynomolgus monkey, rat, rabbit) [~1.0] Positive: hepatocellular adenomas and carcinomas and pulmonary alveolar/ bronchiolar adenomas in female but not male mice Nevirapine (Viramune) C Yes (human) [~1.0] Positive: hepatocellular adenomas and carcinomas in mice and rats Positive at near lethal dose in rodents Positive: ventricular septal defect in rodents Positive: anencephaly, anophthalmia, microphthalmia in cynomolgus monkeys Negative
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Table of Contents Clinical Manual f
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Clinical Manual for Management of t
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Preface—About this Manual | Clini
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Previous Editions Atlanta Contribut
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♦ ♦ ♦ ♦ ♦ | Clinical Manu
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1-2 | Clinical Manual for Managemen
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Initial Physical Examination Backgr
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Genitals/Rectum • Inspect the gen
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Initial and Interim Laboratory and
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Section 1—Testing and Assessment
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Patient Education ♦ ♦ ♦ ♦ D
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Section 2—Health Maintenance and
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References ♦ ♦ ♦ ♦ ♦ ♦
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Occupational Postexposure Prophylax
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Page 81 and 82: contact with the patient. Patients
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Page 85 and 86: Opportunistic Infection Prophylaxis
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Page 89 and 90: Latent Tuberculosis Background Late
Page 91 and 92: INH may cause liver toxicity and it
Page 93: Patient Education ♦ ♦ ♦ ♦
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Page 117 and 118: Reducing Maternal-Infant HIV Transm
Page 119: Some states require written informe
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Page 125 and 126: Nelfinavir (Viracept) Adequate drug
Page 131 and 132: Patient Education ♦ ♦ ♦ ♦
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Page 165 and 166: Section 4—Complications of Antire
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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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of
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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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♦ ♦ ♦ ♦ ♦ ♦ ♦ ♦ ♦
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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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Patient Education ♦ ♦ ♦ ♦
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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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Patient Education ♦ ♦ ♦ ♦
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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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