By the year 2010 the U.S. Census Bureau estimates that 70 million Africans will have died from AIDS (more than the total death toll from WWI and WWII combined).

Table of Contents & Quick Links

Introduction Diagnosis Testing Methods Approved Antiretroviral Drugs When to Initiate Therapy

Drug Regimen Advantages & Disadvantages Monitoring Therapy Changing Therapy Drug Dosing & Interactions Preventing & Treating Occupational Exposure

Introduction

The care for HIV infected persons has changed in the past few years. Before 1987, treatment for HIV infection was not widely available. There are now 14 approved antiretroviral agents available for treating HIV infected persons. Combination therapy such as highly active antiretroviral therapy or HAART has altered the clinical course of HIV/AIDS disease. There have also been notable advances in the management and treatment of opportunistic infections, which affect HIV positive persons. The hope of making HIV/AIDS a more manageable disease is now realizable.

Antiretroviral regimens or treatments are complex, and a high number of HIV/AIDS infected persons have been known to fail therapy. However, because of the need for physicians to have complete knowledge and understanding of the many drug regiments available and their therapeutic significance, we have decided to post guidelines on our website. This guideline is primarily based on the guidelines issued by the International AIDS Society (IAS), the United States Department of Health and Human Services (DHHS), and the World Health Organization (WHO).

Diagnosis of HIV Infections - Recognition of Symptomatic HIV Infections

Although symptomatic HIV infection can be recognized without laboratory testing, the diagnosis should always be confirmed by specific diagnostic tests.

Suggestive Clinical Findings

1. Fever with duration of more than one month
2. Unintended weight loss of more than 10 percent
3. Diarrhea of more than one month duration
4. Mucocutaneous manifestations
5. Generalized lymphadenopathy (extra-inguinal)
6. Severe or recurrent infections
• Past or present multidermatomal herpes zoster
• Hairy leukoplakia
• Warts
• Molluscum contagiosum
• Oral thrush
• Papulonecrotic lesion
• Folliculitis
• Vulvovaginistis
• Severe or recurrent seborrheic dermatitis
• Chronic prurigo
• Reiters syndrome
• Kaposis sarcoma
7. Unexplained neurological manifestations e.g., seizures, motor or sensory deficits, dementia, and progressive headache
8. Chronic cough of a duration of more than one month or unexplained respiratory distress
9. Cytomegalovirus retinitis
10. Extrapulmonary or disseminated and extensive pulmonary tuberculosis
11. Recurrent pneumonia
12. Invasive cervical carcinoma

HIV/AIDS: Case Definition

The presence of clinical AIDS in an adult is defined as an individual who has been identified as meeting the criteria in A and B:

1. Positive test for HIV infection by two tests based on preferably two different antigens.
2. Meets anyone of the following criteria:
1. Weight loss of 10 percent not known to be attributable to a condition unrelated to HIV infection.
2. Chronic diarrhea of more than one month duration. It can be intermittent or constant.
3. Disseminated, miliary or extrapulmonary tuberculosis.
4. Candidiasis of the oesophagus diagnosable as dysphagia, odynophagia, and oral candidiasis.
5. Neurological impairment restricting daily activities that are not known to be due to a condition unrelated to HIV (e.g. trauma).
6. Kaposis sarcoma.

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Methods of HIV Testing (antibody based tests)

Enzyme Linked Immunosorbent Assay (ELISA, EIA)

• Primary screening test for HIV infection. Detects antibodies to HIV.
• May not be effective during the first 3 to 4 weeks of infection because of the lack or absence of p24 and/or gp41 antibodies.
• First becomes positive about 22 to 27 days after acute infection.
• False positive tests occur in multiparous women, recent recipients of influenza or hepatitis B vaccines or multiple transfusions, persons with hematologic malignancies, autoimmune disorders, multiple myeloma, primary biliary cirrhosis or alcoholic hepatitis. False negative ELISAs occur very early or late in the course of HIV infection when antibody production is low.

Confirmatory Tests (Western Blot [WB])

• Detects antibodies to individual HIV proteins and glycoproteins.
• May not be sensitive during the initial infection period of 3 to 4 weeks because of the lack of p24 and or gp41 antibodies.
• Positive WB is defined as the presence of any two of the P24, gp41, and gp 120/gp 160 bands. The absence of all bands is considered a negative test. An indeterminate test has a single band or a combination of bands that does not fit the interpretation of positive.

Detection of Viral Antigens, Virus or Viral Genes

Polymerase Chain Reaction (PCR) and Branched Chain DNA (b–DNA)

• Can detect minute amounts of HIV nucleic acids.
• Viral nucleic acid detection is used to monitor progression of HIV disease and effectiveness of antiretroviral therapy. It can also be a practical and reliable tool for early confirmation of HIV–1 infection.

Using Plasma HIV RNA levels and CD4+ T cell Count for Making Therapy Decisions

• Decisions regarding the initiation of antiretroviral therapy should be guided by laboratory parameters of plasma HIV RNA (viral load) and D4+ Tell cell count, and the clinical condition of the patient. Viral load testing is critical to decisions to either initiate or change antiretroviral therapy.
• In the untreated patient, plasma HIV RNA levels (viral load) must be quantitatively measured at the time of diagnosis and generally every three to six months thereafter.
• CD4+ T cell counts should be measured at the time of diagnosis and every three to six months thereafter.
• Plasma HIV RNA levels should also be measured immediately before initiating antiretroviral therapy and again two to eight weeks after. The second time point allows the clinician to evaluate the initial effectiveness of therapy. In most patients adherence to a point antiretroviral regimen should result in a large decrease (» 0.5 to 0.75 log10) in viral load by two to eight weeks. The viral load should continue to decline over the following weeks and in most persons become below detectable levels (currently defined as > 50 RNA copies/ml) by 12 to 16 weeks. The rate of decline will be affected by the baseline CD4+ T cell count, the initial viral load, potency of the regimen, adherence, prior exposure to antiretroviral drugs and the presence of opportunistic infections.
• The absence of a virologic response of the desired magnitude should make the physician to reassess patents adherence and rule out malabsorption, consider repeat RNA testing which should be repeated every 3-4 months to evaluate the continuing effectiveness of therapy.
• With optimal therapy, viral loads in plasma should be undetectable at 6 months (i.e. below 50 copies of HIV RNA per ml). If HIV RNA remains detectable in plasma after 6 months of therapy, the plasma HIV RNA test should be repeated to confirm the result, and a change in therapy should be considered.
• A significant decrease in CD4+ T lymphocytes is a decrease of >30% cell count from baseline for absolute cell numbers and a decrease of >3% from baseline in percentage of cells. However, viral load and trends in viral load are considered more important than CD4+ counts for choosing therapy.

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Guidelines for Antiretroviral Therapy

These recommendations are from the International AIDS Society (IAS). It represents the consensus of the IAS as of December 1999, and it is based on expert opinions, clinical, and treatment data. Recent and available data strongly suggests that clinically significant immune reconstitution (return of pathogens and HIV specific lymphoproliferative responses, and gradual increase in naïve CD4+ cells) may be achieved with potent therapy. There is a growing awareness though, of difficulties with the use of potent treatments. Even in clinical trials therapies do not achieve levels of HIV RNA below 50 copies/ml in a substantial number of patients. The goal of HIV treatments is more of a long-term management of chronic infection. The challenge to clinicians is to chart a strategic therapeutic course for individual patients such that medications are used to maximize effectiveness over time.

Approved Antiretroviral Drugs

• Nucleoside Analog Reverse Transcriptease Inhibitors (NRTIs)
• Zidovudine (ZDV/AZT)
• Lamivudine (3 TC)
• Stavudine (d4T)
• Didanosine (ddl)
• Zalcitabine (ddC)
• Abacavir

Non-Nucleoside Analog Reverse Transcriptase Inhibitors (NNRTIs)

• Nevirapine
• Delavirdine
• Efavirenz

Protease Inhibitors

• Indinavir
• Ritonavir
• Saquinavir
• Nelfinavir
• Amprenavir

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When to Initiate Antiretroviral Therapy

Potent therapy can at least partially restore pathogen specific immunity to recall antigens. Naïve CD4+ cells, crucial for response to new antigenic challenges, can be restored gradually with prolonged virus suppression. Attaining CD4+ cell counts in the normal range occurs more quickly in patients having higher CD4+ cell counts at the initiation of treatment.

Plasma HIV RNA levels and CD4+ cell counts are somewhat arbitrary but useful guidelines for decision–making regarding treatment. Treatment and therapy is recommended for patients with the following:

1. HIV RNA level above 30,000 copies/ml irrespective of CD4+ cell count.
2. CD4+ cell counts below 350/m 1 irrespective of HIV RNA level.
3. Both plasma HIV RNA levels in the 5000 to 30,000 copies/ml range and CD4+ cell counts between 350 and 500 m 1.
4. All patients with symptomatic established HIV infections.

Acute Treatment of a Serious Opportunistic Infection Takes Precedence Over Antiretroviral Therapy Initiation.

Initial Therapy

Initial therapy or treatment of 2 NRTIs and a protease inhibitor (or two protease inhibitors), or 2NRTIs and an NNRTL are recommended. Persons at high short–term risk for disease progression (e.g. CD4+ cell count < 50 cells/m I or HIV RNA > 100,000 copies/ml) may benefit with more potent combination (e.g. 4 drug regimens of drugs from all 3 classes with dual protease inhibitors).

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Advantages and Disadvantages of Possible Antiretroviral Regimens

Regimen	Advantages	Disadvantages
Protease Inhibitor +2NRTIs	Clinical Data Longest experience for viral suppression	Complexity and high pill burden Compromises future protease inhibitors regimens Long term toxicity
NNRTI + 2NRTIs	Defers Protease inhibitor Low pill burden	Limited long term data Compromises future NNRTI regimen
2 Protease inhibitors + NRTIs	High potency Convenient dosing	High pill burden with some regimens Unknown long term toxicity
Regimens under Consideration
3 NRTIS	Defers Pls and NNRTI Low pill burden	Lower Potency Compromises future NRTI regimen
Protease inhibitor + NNRTI + NRTI	High Potential	Complexity and toxicity Compromises future regimens

NRTIs

Dual NRTIS are used in most 3 or 4 drug regimens. Possible NRTI combinations include Zidovudine with Didanosine, Zalcitabine, Lamivudine or Stavudine with Didanosine or Lamivudine. Abacavir is a potent drug in treatment naïve patients. Progressive accumulation of mutations, especially after zidovudine–lamivudine use, results in loss of Abacavir's effectiveness. Abacavir will likely be useful in initial regimens, but its effectiveness with NRTI combinations other than Zidovudine and Lamivudine is not well known.

NNRTIs

There are no direct comparisons of the potencies of the three drugs. The choice of a particular NNRTI should be based on supporting evidence, convenience, and the potential for adverse reaction. The potential for high-level resistance as a result of a single reverse transcriptase mutation suggests that NNRTIs should be used only in regimens designed to maximally suppress HIV. The NNRTIs generally will not be active if resistance to a previous NNRTI has emerged. Since this class of drugs is metabolized by the Cytochrone p450 system, drug to drug interactions with protease inhibitors and other drugs should be considered.

Protease Inhibitors

Long term (>48 weeks) virologic data on three drug regimens including Ritonavir, Indinavir or Nelfinavir, show persistent HIV suppression and warrant their continued use in initial regimens. Full dose Ritonavir has adverse effects that limit long term adherence, and its future use is likely to be in combination with other protease inhibitors. Hard gel Saquinavir should not be used as part of the three drug regimens (i.e. with 2 NRTIs) because of poor oral availability. Amprenavir, which may be considered, is taken as eight 150mg pills twice daily; its long term responses and adverse effects in initial regimens are not well defined.

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Monitoring Antiretroviral Therapy

Adherence: An adherence rate of at least 95 percent is critical for optimal results. Adherence barriers such as number and timing of doses, number and size of pills, food restrictions, and particularly adverse effects should be weighed before selecting treatment regimens and considered in designing programs to enhance adherence.

Monitoring Therapy

A minimum of two CD4+ cell counts and two HIV RNA measurements should be obtained preferably from the same laboratory, and on two separate visits, before initiating therapy.

Failure to achieve the target level of less than 50 copies/ml by 16 to 24 weeks should raise concerns and prompt considerations of poor adherence, inadequate drug absorption, or drug resistance.

HIV RNA levels should be monitored within one month of initiating therapy or changing therapy. Keep monitoring monthly until the goal of therapy (levels before detection) is reached, and every 2 to 3 months thereafter. The CD4+ cell count increases during therapy reflect at least partial immune system reconstitution. Progressive CD4+ cell count increases may occur throughout the first several years of therapy.

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Changing Therapy

There are three main reasons for changing an antiretroviral therapy:

1. Drug Failure
2. Adverse Effects
3. Regimen Inconvenience

Drug Failure: This is defined as "inadequate viral suppression" (virologic failure defined as a confirmed detectable HIV RNA), unsatisfactory increase in CD4+ cell count or clinical progression.

Levels of HIV RNA between 50 and 500 copies/ml are often associated with higher risk of resistance than levels below 50 copies/ml. Lack of adherence to a complete regimen is often the primary reason for virologic failure, and thus alteration of a failing regimen may not directly address the underlying problem. Though, the median rise in CD4+ cell count in patients with HIV RNA levels below detection limits is about 150/mI during the first year. Less robust CD4+ cell responses may occur. Because of this a therapy change based solely on CD4+ cell response is not recommended.

Drug (Toxicity and) Inconvenience

If an individual drug in a regimen is changed or for patient convenience, the full regimen must be reviewed regarding potency, residual resistance, and drug to drug interaction. If a successful regimen is unacceptable because of inconvenience, change in therapy can be considered if regimen simplification increases the likelihood of patient adherence.

Changing the Regimen

In the absence of virologic failure

• For intolerance or adverse effects arising from an otherwise successful regimen, substitute the individual drug.
• In the event of induced rash through use of NNRTI, substitution with other NNRTIs must be carefully monitored because of the risk of shared toxicity.
• In the event of hypersensitivity to Abacavir, the use of the drug should be discontinued. Rechallenge must not be attempted because of past results of severe toxicity and death.

Due to virologic failure

• For patients with low detectable HIV RNA after some months of potent therapy and who do not have an identified resistance to drugs in their current regimen, the addition of a new drug (for intensification) may be a better alternative to a complete change in regimen.
• Patients with high level of persistent viremia with continued drug use, resistance or its emergence may be likely.
• If the decision is made to change treatment regimens (therapy), consider a change in all drug components.
• NNRTIs have high risks of cross-resistance. The use of a new NNRTIs is not recommended as an alternative for a failing NNRTI containing regimen.
• Similarly, NRTIs (like NNRTIs) have a high degree of drug cross-resistance. When possible, select a drug from a new class.
• Choose only the drug regimen with the highest predicted potency, tolerance, and patient's adherence.

Should Therapy Be Stopped?

It is reasonable based on clinical and immunologic benefit, despite continued viremia in patients with advanced disease and few or no antiretroviral options, to continue treatment as long as necessary. However, drug interruptions, reduced dosage or the substitution of one or more drugs in a complex regime, may be necessary to avoid toxicity. During drug discontinuation, monitor the CD4+ cell count and HIV RNA levels to identify worsening values.

Reason for Change	Change To
Toxicity/Intolerance - HIV RNA suppressed below target or still above target but less than 8-16 wk+ with therapy	Change the offending drug
HIV RNA above target. More than 8-16 wk+ on therapy or prior success	Change entire regimen
Difficulty with Adherence
HIV RNA suppressed below target, but adherence problems exist or HIV RNA above target but less than 6-16 wk with therapy	Change to simplified regimen with equal potency. May substitute single drug if you can identify the offending drug
HIV RNA above target, more than 8-16 wk+ with therapy or prior success	Change entire regimen
Virologic Failure
Failure to reach target viral load within 8-16 wk of therapy	Continue current regimen: assess adherence; consider intensification
Failure to reach target viral load within 24-36 wk of therapy or prior success but now confirmed drug failure	Change entire regimen

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Antiretroviral Drugs, Dosing, and Interaction with An–Tb Drugs

Antiretroviral Summary Tables

Chemical	Generic	Brand	Dose	Comments
AZT	Zedovudine	Zidovir	300mg b.i.d.	Initial nausea. Headache, fatigue, anemia, neutropenia, neuropathy, myopathy
3TC	Lamivudine	Lamivir	150mg b.i.d.	Well tolerated. Active against hepatitis B
AZT+3TC	Zidovudine	Duovir	1 Tablet b.i.d.	Combination tablet contains 300mg of AZT and 150mg of 3TC
D4T	Lamivudine/Stavudine	Stavir	20-40mg 2 times/day	Peripheral neuropathy may appear
ddL	Didanosine	Videx	200mg b.i.d. or 400mg o.d. (>60 kg body weight	Take on empty stomach. Alcohol may increase toxicity.
ddC	Zalcitabine	Hivid	0.375-0.75mg t.i.d.	Do not take with antacids
1592U89	Abacavir	Ziagen	300mg b.i.d.	Up to 3% chance of hypersensitivity reactions. Resolves within 2 days of discontinue. Do not Rechallenge
Protease Inhibitors (Pls.)
	Saquinavir hard gel caps	Invirase	600mg t.i.d.	Take with fatty meals. Poor absorption(4%)
	Saquinavir hard gel caps	Fortovase	1200mg t.i.d.	Take with fatty food (>28 gram). Refrigerate
	Ritonavir	Norvir	600mg b.i.d.	Take with meals. Titrated lead in dosing: 300mg b.i.d. day 1 400mg b.i.d. day 2–3 500 mg b.i.d. day 4
	Indinavir	Crixivan	600mg t.i.d.	Take 1 hour before eating or 2 hours after meal. Drink at least 1.5 liters of water per day
	Nelfinavir	Viracept	750mg t.i.d. or 1250mg b.i.d.	Not recommended for persons under three years old.
	Amprenavir	Agenerase	1200mg	Rash (20%), Nausea, diarrhea
NNRTIs	Non-Nucleoside	Reverse	Transcriptase	Inhibitors
	Nevirapine	Nevimune	200mg b.i.d. or 400mg o.d.	Lead in dosing, 200mg o.d. for first 14 days
	Efavirenz	Sustiva	600mg o.d. (at bedtime)	Initial dizziness. Avoid Clarithromycin
	Delavirdine	Rescriptor	400mg t.i.d.	Transient rash

All medications are based on manufacturers provided prescribing information.

TB Medications/Antiretroviral Drug Interactions

The information contained in the chart below is based on pharmacokinetic data. Most problematic drug interactions occur between rifampicin and PIs or NNRTLs. Because the interactions for rifabutin are less pronounced, it (rifabutin) can be considered as an alternative to rifampicin when co-administered with PIs or NNRTIs. Clinical judgement is recommended in light of decreased anti–TB activity of rifabutin when compared to rifampicin.

There are no significant drug interactions between TB medications and NRTIs. The only exception is ddI, which should be dosed one hour apart due to its antacid buffer. There may be an increased risk of neuropathy if ddC and isoniazid are co-administered. Rifampicin reduces the AUC of AZT, but this is not clinically significant, as intracellular levels of AZT triphosphate are not significantly affected. Ethambutol, pyrazinamide, and fluoroquinolones have no known CYP3A4 effect and thus no known interactions with antiretrovirals.

	Isoniazid Mild Inhibitor of CYP3A4	Rifampicin Potent Inducer of CYP3A4	Rifabutin Moderate Inducer of CYP3A4
Nevirapine	No Known Interaction	37% in NVP AUC. No change in rifampicin. Insufficient data to recommend change in dosage	16% in NVP AUC. Moderate in rifabutin. Consider rifabutin to 450mg
Delavirdine	No Known Interaction	DO NOT COMBINE–96% in DLV, no change in rifampicin	DO NOT COMBINE–80% in DLV AUC, 342% in rifabutin AUC
Efavirenz	No Known Interaction	13% EFV AUC. No change in rifampicin. Unclear significance, no dose change recommended	No change in EFV, 38% in rifabutin AUC. Consider rifabutin to 450mg
Ritonavir	No Known Interaction	DO NOT COMBINE – 35% in RTV AUC and 25% in C max. No change in rifampicin	DO NOT COMBINE – 293% in rifabutin AUC rifabutin to 150mg QOD currently under investigation
Saquinavir	No Known Interaction	DO NOT COMBINE – 80% IN SQV AUC and C max	45% in SQV AUC. SQC–SGC may be okay but no clinical studies
Indinavir	13% in INH AUC after one week	DO NOT COMBINE – 92% in IDV AUC	–rifabutin to 150mg QD (173% in rifabutin AUC, 34% in IDV AUC)
Nelfinavir	No Known Interaction	DO NOT COMBINE – 82% NFV AUC	–rifabutin to 150mg QD (207% in rifabutin AUC, 32% in NFV AUC)
Amprenavir	No Known Interaction	DO NOT COMBINE – 81% in APV AUV	–rifabutin to 150mg QD (200% in rifabutin AUC, 14% in APV AUC)
Sources: JAMA 2000; 283:381-390 Clinical Management of HIV and AIDS at District Level; WHO, 1998 Guidelines for the Use of Antiretroviral Agents in HIV–Infected Adults and Adolescents; U.S. Dept of Health & Human Services, January 2000 Nasser NN, Skiest DJ, Greg CR, Keosar P: Parkland Pocket Guide to HIV Care

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Preventing and Treating Occupational Exposure to HIV: A User's Guide

This guideline discusses the risks of acquiring HIV faced by medical personnel or clinic workers when caring for HIV infected persons. It underlines how these risks can be evaluated and various measures which can be taken to prevent such infections. This guidelines is based on preventive guidelines for medical practitioners issued by the Center for Disease Control (CDC, Atlanta, United States).

HIV or the Human Immunodeficiency Virus is transmitted from person to person under the following routes:

• Sexual contact during which body fluids are exchanged.
• Transfusion of infected blood and blood products.
• Perinatal transmission from mother to child.
• Contact with infected needles and body fluids.

What is Occupational Exposure to HIV Infection?

Occupational exposure is the risk faced by health personnel who care for and treat HIV infected persons. It is the risk they are exposed through contact with HIV infected blood and body fluids.

Who is at Risk for Occupational Exposure to HIV infection?

All health care workers who care for HIV infected persons, or come in contact with HIV infected blood or body fluids are at risk. These include physicians, nurses, laboratory workers, paramedics, etc.

What is the Risk of Occupational Exposure?

The risk of occupational exposure varies depending on the type of exposure. The risk from a percutaneous injury (needle prick or cut with a sharp object) is estimated to be about 0.3 percent (or 3 out of a thousand needle pricks). Risks from mucous membrane exposure (exposure from contact with mucous membranes of the eyes, nose, and mouth or contact with chapped, abraded, or inflamed skin is much lower at about 0.9 percent. Also, any kind of direct contact with concentrated HIV in a laboratory is considered very risky.

Needle Prick

This is common among nurses. Percutaneous injury and infections are common during surgical procedures. Factors representing risks are the duration of the surgical procedure, volume of blood loss, and if the surgery involves major vascular or intraabdominal gynecologic surgery.

Contact with Blood

Contact with HIV infected blood with intact skin for a prolonged period or over an extensive area of the skin, may carry a risk. Isolated skin exposure for a short period probably does not represent a risk.

Factors Which Increase the Likelihood of Exposure Risk

Some of the factors that pose risks are:

• The depth of the injury (in case of a sharp object)
• Whether the device was visibly contaminated with blood
• Whether the procedure involved placing a needle directly in the artery or vein
• Whether the needle was a hollow bore needle or a solid needle such as a suture needle
• The size of the needle - large as opposed to small
• The HIV infected persons viral load (amount of HIV in circulation)
• The amount of blood or fluid involved
• The duration of the exposure

Which Body Fluids Transmits HIV?

Blood and body fluids are considered infectious. Other infectious materials include semen, vaginal secretions, CSF, pleural, peritoneal, pericardial, aminiotic fluids or tissue.

Does Exposure to Saliva Cause HIV?

Exposure to saliva, tears, sweat, and non–bloody urine has not been proven to cause HIV infection.

Areas of Frequent Contact for Health Care Workers

The hand is the most frequent area of contact for health care workers. Face contacts are common in orthopaedics and obstetrics. Eye or mucous membrane contacts may occur in cases where there is the splattering of blood.

How Can Exposure Risks Be Reduced?

There are several preventive measures for reducing the risk of infection to HIV, and they include the following:

• The use of universal precautions.
• The use of two pair of gloves by surgeons. The obstetrician may adopt other barriers such as the use of a face shield, impervious gowns, and shoe covers. Goggles can be used to prevent contact with the eyes.
• Exercise care during procedures such as endoscopy, ENT surgery, and other situations where the splattering of blood is anticipated.
• The use of impervious needle disposal containers.
• Transport of samples in sealed containers.
• Use of Contingency Plans for Dealing with Occupational Exposure.

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