FDA label 21d1bc4f-a5fb-428c-8f4b-f844bcd7db70

WARNING THE USE OF HIVID HAS BEEN ASSOCIATED WITH SIGNIFICANT CLINICAL ADVERSE REACTIONS, SOME OF WHICH ARE POTENTIALLY FATAL. HIVID CAN CAUSE SEVERE PERIPHERAL NEUROPATHY AND BECAUSE OF THIS SHOULD BE USED WITH EXTREME CAUTION IN PATIENTS WITH PREEXISTING NEUROPATHY. HIVID MAY ALSO RARELY CAUSE PANCREATITIS AND PATIENTS WHO DEVELOP ANY SYMPTOMS SUGGESTIVE OF PANCREATITIS WHILE USING HIVID SHOULD HAVE THERAPY SUSPENDED IMMEDIATELY UNTIL THIS DIAGNOSIS IS EXCLUDED. LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF ANTIRETROVIRAL NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION, INCLUDING HIVID (SEE WARNINGS ). IN ADDITION, RARE CASES OF HEPATIC FAILURE AND DEATH CONSIDERED POSSIBLY RELATED TO UNDERLYING HEPATITIS B AND HIVID HAVE BEEN REPORTED (SEE WARNINGS AND PRECAUTIONS ).

WARNINGS SIGNIFICANT CLINICAL ADVERSE REACTIONS, SOME OF WHICH ARE POTENTIALLY FATAL, HAVE BEEN REPORTED WITH HIVID. PATIENTS WITH DECREASED CD 4 CELL COUNTS APPEAR TO HAVE AN INCREASED INCIDENCE OF ADVERSE EVENTS. Peripheral Neuropathy THE MAJOR CLINICAL TOXICITY OF HIVID IS PERIPHERAL NEUROPATHY, WHICH MAY OCCUR IN UP TO 1/3 OF PATIENTS WITH ADVANCED DISEASE TREATED WITH HIVID. The incidence in patients with less-advanced disease is lower. HIVID-related peripheral neuropathy is a sensorimotor neuropathy characterized initially by numbness and burning dysesthesia involving the distal extremities. These symptoms may be followed by sharp shooting pains or severe continuous burning pain if the drug is not withdrawn. The neuropathy may progress to severe pain requiring narcotic analgesics and is potentially irreversible. In some patients, symptoms of neuropathy may initially progress despite discontinuation of HIVID. With prompt discontinuation of HIVID, the neuropathy is usually slowly reversible. There are no data regarding the use of HIVID in patients with preexisting peripheral neuropathy since these patients were excluded from clinical trials; therefore, HIVID should be used with extreme caution in these patients. Individuals with moderate or severe peripheral neuropathy, as evidenced by symptoms accompanied by objective findings, are advised to avoid HIVID. HIVID should be used with caution in patients with a risk of developing peripheral neuropathy: patients with low CD 4 cell counts (CD 4 <50 cells/mm 3 ), diabetes, weight loss and/or patients receiving HIVID concomitantly with drugs that have the potential to cause peripheral neuropathy (see PRECAUTIONS: Drug Interactions ). Careful monitoring is strongly recommended for these individuals. HIVID should be stopped promptly if signs or symptoms of peripheral neuropathy occur, such as when moderate discomfort from numbness, tingling, burning or pain of the extremities progresses, or any related symptoms occur that are accompanied by an objective finding (see DOSAGE AND ADMINISTRATION ). Pancreatitis PANCREATITIS, WHICH HAS BEEN FATAL IN SOME CASES, HAS BEEN OBSERVED WITH THE ADMINISTRATION OF HIVID. Pancreatitis is an uncommon complication of HIVID occurring in up to 1.1% of patients. Patients with a history of pancreatitis or known risk factors for the development of pancreatitis should be followed more closely while on HIVID therapy. Of 528 HIVID-treated patients enrolled in an expanded-access safety study (N3544), who had a history of prior pancreatitis or increased amylase, 28 (5.3%) developed pancreatitis and an additional 23 (4.4%) developed asymptomatic elevated serum amylase. Treatment with HIVID should be stopped immediately if clinical signs or symptoms (nausea, vomiting, abdominal pain) or if abnormalities in laboratory values (hyperamylasemia associated with dysglycemia, rising triglyceride level, decreasing serum calcium) suggestive of pancreatitis should occur. If clinical pancreatitis develops during HIVID administration, it is recommended that HIVID be permanently discontinued. Treatment with HIVID should also be interrupted if treatment with another drug known to cause pancreatitis (eg, intravenous pentamidine) is required (see Drug Interactions ). Lactic Acidosis/Severe Hepatomegaly With Steatosis and Hepatic Toxicity Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including HIVID and other antiretrovirals. 5,6 A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering HIVID to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. Treatment with HIVID should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). IN ADDITION, RARE CASES OF HEPATIC FAILURE AND DEATH CONSIDERED POSSIBLY RELATED TO UNDERLYING HEPATITIS B AND HIVID HAVE BEEN REPORTED. Treatment with HIVID in patients with preexisting liver disease, liver enzyme abnormalities, a history of ethanol abuse or hepatitis should be approached with caution. Treatment with HIVID should be suspended in any patient who develops clinical or laboratory findings suggestive of pronounced hepatotoxicity. In clinical trials, drug interruption was recommended if liver function tests exceeded >5 times the upper limit of normal. Other Serious Toxicities a) Oral Ulcers : Severe oral ulcers occurred in up to 3% of patients receiving HIVID in CPCRA 002 and ACTG 175; less severe oral ulcerations have occurred at higher frequencies in other clinical trials. b) Esophageal Ulcers: Infrequent cases of esophageal ulcers have also been attributed to HIVID therapy. Interruption of HIVID should be considered in patients whodevelop esophageal ulcers that do not respond to specific treatment for opportunistic pathogens in order to assess a possible relationship to HIVID. c) Cardiomyopathy/Congestive Heart Failure: Cardiomyopathy and congestive heart failure in patients with AIDS have been associated with the use of nucleoside analogues. Infrequent cases have been reported in patients receiving HIVID. Treatment with HIVID in patients with baseline cardiomyopathy or history of congestive heart failure should be approached with caution. d) Anaphylactoid Reaction: An anaphylactoid reaction was reported in a patient receiving both HIVID and zidovudine. In addition, there have been several reports of hypersensitivity reactions (including anaphylactic reaction or urticaria without other signs of anaphylaxis).

ADVERSE REACTIONS (SEE WARNINGS .) Table 2 and Table 3 summarize the clinical adverse events and laboratory abnormalities, respectively, that occurred in≥1% of patients in the comparative monotherapy trial (CPCRA 002) of HIVID vs didanosine (ddI), and the comparative combination trial (ACTG 175) of zidovudine (ZDV) monotherapy vs HIVID and zidovudine combination therapy, respectively. Other studies have found a higher or lower incidence of adverse experiences depending upon disease status, generally being lower in patients with less advanced disease. Table 2 Percentage of Patients With Clinical Adverse Experience ≥ Grade 3 Grade 2 Adverse Events possibly or probably related to treatment or unassessable were included if study drug dosage was changed or interrupted. Grade 3 severity: event causing marked limitation in activity, requiring medical care and possible hospitalization. Grade 4 severity: completely disabling, unable to care for self, requiring active medical intervention, probable hospitalization or hospice care. in ≥1% of Patients Receiving HIVID CPCRA 002 ZDV Intolerant or Failure ACTG 175 All relationships. ZDV Naive/Experienced HIVID 0.750 mg q8h ddI 250 mg q12h ZDV 200 mg q8h HIVID+ZDV 0.750 mg q8h +200 mg q8h n=237 n=230 n=619 n=615 Body System/Adverse Event Systemic Fatigue 3.8 2.6 2.7 2.3 Headache 2.1 1.3 2.4 2.6 Fever 1.7 0.4 2.7 2.9 Gastrointestinal Abdominal Pain 3.0 7.0 2.3 1.8 Oral Lesions/Stomatitis Adverse experiences were combined to form this category. 3.0 0.0 0.6 1.5 Vomiting/Nausea 3.4 7.0 4.9 2.1 Diarrhea/Constipation 2.5 17.4 2.9 1.0 Hepatic Abnormal Hepatic Function 8.9 7.0 See Table 3 . Neurological Convulsions 1.3 2.2 Peripheral Neuropathy CPCRA 002 included patients who were dose-adjusted for Grade 2 events; ACTG 175 required dose adjustment for Grade 2 peripheral neuropathy but recorded only Grade 3 events. 28.3 13.0 3.1 3.3 Skin Rash/Pruritus/Urticaria 3.4 3.9 1.8 1.6 Metabolic and Nutrition Pancreatitis 0.0 1.7 0.2 0.5 Psychological Depression 0.4 0.0 1.1 1.8 Musculoskeletal Painful/Swollen Joints 0.4 0.0 0.3 1.0 Table 3 Percentage of Patients With Laboratory Abnormalities — Protocol Grade 3/4 CPCRA 002 Grade 3 or higher reported for CPCRA 002. ZDV Intolerant or Failure ACTG 175 ZDV Naive/Experienced HIVID 0.750 mg q8h n=237 ddI 250 mg q12h n=230 ZDV 200 mg q8h n=619 HIVID+ZDV 0.750 mg q8h +200 mg q8h n=615 Laboratory Abnormality Anemia (<7.5 gm/dL) 8.4 7.4 1.8 3.1 Leukopenia (<1500 cells/mm 3 ) 13.1 9.6 N/A N/A Not available. N/A Eosinophilia (>1000 cells/mm 3 or 25%) 2.5 1.7 N/A N/A Neutropenia (<750 cells/mm 3 ) 16.9 11.7 1.9 4.2 Thrombocytopenia (<50,000 cells/mm 3 ) 1.3 4.8 1.1 1.8 CPK Elevation (>4× ULN) 0.8 0.0 5.8 5.7 ALT (SGPT) (>5 × ULN) N/A N/A 3.6 5.0 AST (SGOT) (>5 × ULN) 7.6 5.7 2.9 4.1 Bilirubin (>2.5 × ULN) 0.8 0.9 0.5 1.0 GGT (>5 × ULN) N/A N/A 0.5 1.0 Amylase (>2 × ULN) 5.1 3.9 1.0 1.5 Hyperglycemia (>250 mg/dL) 0.0 1.7 0.8 2.0 Additional clinical adverse experiences associated with HIVID that occurred in <1% of patients in CPCRA 002 (at least possibly related, Grade 3 or higher), ACTG 175 (any relationship, Grade 3/4) or in other clinical studies are listed below by body system. Several of these events occurred in slightly higher rates in other studies. The incidence of adverse experiences varied in different studies, generally being lower in patients with less-advanced disease. Body as a Whole: abnormal weight loss, asthenia, cachexia, chest tightness or pain, chills, cutaneous/allergic reaction, debilitation, difficulty moving, dry eyes/mouth, edema, facial pain or swelling, flank pain, flushing, increased sweating, lymphadenopathy, hypersensitivity reactions (see WARNINGS ), malaise, night sweats, pain, pelvic/groin pain, rigors, redistribution/accumulation of body fat (see PRECAUTIONS: Fat Redistribution ). Cardiovascular: abnormal cardiac movement, arrhythmia, atrial fibrillation, cardiac failure, cardiac dysrhythmias, cardiomyopathy, heart racing, hypertension, palpitation, subarachnoid hemorrhage, syncope, tachycardia, ventricular ectopy. Endocrine/Metabolic: abnormal triglycerides, abnormal lipase, altered serum glucose, decreased bicarbonate, diabetes mellitus, glycosuria, gout, hot flushes, hypercalcemia, hyperkalemia, hyperlipemia, hypernatremia, hyperuricemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, increased nonprotein nitrogen, lactic acidosis. Gastrointestinal: abdominal bloating or cramps, acute pancreatitis, anal/rectal pain, anorexia, bleeding gums, bloody or black stools, colitis, dental abscess, dry mouth, dyspepsia, dysphagia, enlarged abdomen, epigastric pain, eructation, esophageal pain, esophageal ulcers, esophagitis, flatulence, gagging with pills, gastritis, gastrointestinal hemorrhage, gingivitis, glossitis, gum disorder, heartburn, hemorrhagic pancreatitis, hemorrhoids, increased saliva, left quadrant pain, melena, mouth lesion, odynophagia, painful sore gums, painful swallowing, pancreatitis, rectal hemorrhage, rectal mass, rectal ulcers, salivary gland enlargement, sore tongue, sore throat, tongue disorder, tongue ulcer, toothache, unformed/loose stools, vomiting. Hematologic: absolute neutrophil count alteration, anemia, epistaxis, decreased hematocrit, granulocytosis, hemoglobinemia, leukopenia, neutrophilia, platelet alteration, purpura, thrombus, unspecified hematologic toxicity, white blood cell alteration. Hepatic: abnormal lactate dehydrogenase, bilirubinemia, cholecystitis, decreased alkaline phosphatase, hepatitis, hepatocellular damage, hepatomegaly, increased alkaline phosphatase, jaundice. Musculoskeletal: arthralgia, arthritis, arthropathy, arthrosis, back pain, backache, bone pains/aches, bursitis, cold extremities, extremity pain, joint inflammation, leg cramps, muscle aches, muscle weakness, muscle disorder, muscle stiffness, muscle cramps, myalgia, myopathy, myositis, neck pain, rib pain, stiff neck. Neurological: abnormal coordination, aphasia, ataxia, Bell's palsy, confusion, decreased concentration, decreased neurological function, disequilibrium, dizziness, dysphonia, facial nerve palsy, focal motor seizures, grand mal seizure, hyperkinesia, hypertonia, hypokinesia, memory loss, migraine, neuralgia, neuritis, paralysis, seizures, speech disorder, status epilepticus, stupor, tremor, twitch, vertigo. Psychological: acute psychotic disorder, acute stress reaction, agitation, amnesia, anxiety, confusion, decreased motivation, decreased sexual desire, depersonalization, emotional lability, euphoria, hallucination, impaired concentration, insomnia, manic reaction, mood swings, nervousness, paranoid state, somnolence, suicide attempt, dementia. Respiratory: acute nasopharyngitis, chest congestion, coughing, cyanosis, difficulty breathing, dry nasal mucosa, dyspnea, flu-like symptoms, hemoptysis, nasal discharge, pharyngitis, rales/rhonchi, respiratory distress, sinus congestion, sinus pain, sinusitis, wheezing. Skin: acne, alopecia, bullous eruptions, carbuncle/furuncle, cellulitis, cold sore, dermatitis, dry skin, dry rash desquamation, erythematous rash, exfoliative dermatitis, finger inflammation, follicular rash, impetigo, infection, itchy rash, lip blisters/lesions, macular/papular rash, maculopapular rash, moniliasis, mucocutaneous/skin disorder, nail disorder, photosensitivity reaction, pruritic disorder, pruritus, skin disorder, skin lesions, skin fissure, skin ulcer, urticaria. Special Senses: abnormal vision, blurred vision, burning eyes, decreased taste, decreased vision, ear pain/problem, ear blockage, eye abnormality, eye inflammation, eye itching, eye pain, eye irritation, eye redness, eye hemorrhage, fluid in ears, hearing loss, increased tears, loss of taste, mucopurulent conjunctivitis, parosmia, photophobia, smell dysfunction, taste perversion, tinnitus, unequal-sized pupils, xerophthalmia, yellow sclera. Urogenital: abnormal renal function, acute renal failure, albuminuria, bladder pain, dysuria, frequent urination, genital lesion/ulcer, increased blood urea nitrogen, increased creatinine, micturition frequency, nocturia, painful penis sore, pain on urination, penile edema, polyuria, renal cyst, renal calculus, testicular swelling, toxic nephropathy, urinary retention, vaginal itch, vaginal ulcer, vaginal pain, vaginal/cervix disorder, vaginal discharge.

<table ID="t2" width="100%"> <caption>Table 2 Percentage of Patients With Clinical Adverse Experience &#x2265; Grade 3<footnote ID="table2foot1">Grade 2 Adverse Events possibly or probably related to treatment or unassessable were included if study drug dosage was changed or interrupted.</footnote> <footnote>Grade 3 severity: event causing marked limitation in activity, requiring medical care and possible hospitalization. Grade 4 severity: completely disabling, unable to care for self, requiring active medical intervention, probable hospitalization or hospice care.</footnote> in &#x2265;1% of Patients Receiving HIVID</caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <thead> <tr> <th styleCode="lrule"/> <th colspan="2" styleCode="lrule">CPCRA 002<footnoteRef IDREF="table2foot1"/> ZDV Intolerant or Failure</th> <th colspan="2" styleCode=" lrule rrule">ACTG 175<footnote>All relationships.</footnote> ZDV Naive/Experienced</th> </tr> <tr> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule">HIVID 0.750 mg q8h</th> <th styleCode="lrule toprule">ddI 250 mg q12h</th> <th styleCode="lrule toprule">ZDV 200 mg q8h</th> <th styleCode="lrule toprule rrule">HIVID+ZDV 0.750 mg q8h +200 mg q8h</th> </tr> <tr> <th styleCode="lrule"/> <th styleCode="lrule">n=237</th> <th styleCode="lrule">n=230</th> <th styleCode="lrule">n=619</th> <th styleCode="lrule rrule">n=615</th> </tr> <tr> <th styleCode="lrule toprule">Body System/Adverse Event</th> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule rrule"/> </tr> </thead> <tbody> <tr> <td styleCode="lrule">Systemic</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule"> Fatigue</td> <td styleCode="lrule">3.8</td> <td styleCode="lrule">2.6</td> <td styleCode="lrule">2.7</td> <td styleCode="lrule rrule">2.3</td> </tr> <tr> <td styleCode="lrule"> Headache</td> <td styleCode="lrule">2.1</td> <td styleCode="lrule">1.3</td> <td styleCode="lrule">2.4</td> <td styleCode="lrule rrule">2.6</td> </tr> <tr> <td styleCode="lrule botrule"> Fever</td> <td styleCode="lrule botrule">1.7</td> <td styleCode="lrule botrule">0.4</td> <td styleCode="lrule botrule">2.7</td> <td styleCode="lrule botrule rrule">2.9</td> </tr> <tr> <td styleCode="lrule">Gastrointestinal</td> <td styleCode="lrule"> </td> <td styleCode="lrule"> </td> <td styleCode="lrule"> </td> <td styleCode="lrule rrule"> </td> </tr> <tr> <td styleCode="lrule"> Abdominal Pain</td> <td styleCode="lrule">3.0</td> <td styleCode="lrule">7.0</td> <td styleCode="lrule">2.3</td> <td styleCode="lrule rrule">1.8</td> </tr> <tr> <td styleCode="lrule"> Oral Lesions/Stomatitis<footnote ID="table2foot2">Adverse experiences were combined to form this category.</footnote> </td> <td styleCode="lrule">3.0</td> <td styleCode="lrule">0.0</td> <td styleCode="lrule">0.6</td> <td styleCode="lrule rrule">1.5</td> </tr> <tr> <td styleCode="lrule"> Vomiting/Nausea<footnoteRef IDREF="table2foot2"/> </td> <td styleCode="lrule">3.4</td> <td styleCode="lrule">7.0</td> <td styleCode="lrule">4.9</td> <td styleCode="lrule rrule">2.1</td> </tr> <tr> <td styleCode="lrule botrule"> Diarrhea/Constipation<footnoteRef IDREF="table2foot2"/> </td> <td styleCode="lrule botrule">2.5</td> <td styleCode="lrule botrule">17.4</td> <td styleCode="lrule botrule">2.9</td> <td styleCode="lrule botrule rrule">1.0</td> </tr> <tr> <td styleCode="lrule">Hepatic</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule botrule"> Abnormal Hepatic Function</td> <td styleCode="lrule botrule">8.9</td> <td styleCode="lrule botrule">7.0</td> <td styleCode="lrule botrule"> <footnote ID="table2foot3">See <linkHtml href="#t3">Table 3</linkHtml>.</footnote> </td> <td styleCode="lrule botrule rrule"> <footnoteRef IDREF="table2foot3"/> </td> </tr> <tr> <td styleCode="lrule">Neurological</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule"> Convulsions</td> <td styleCode="lrule">1.3</td> <td styleCode="lrule">2.2</td> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule botrule"> Peripheral Neuropathy<footnote>CPCRA 002 included patients who were dose-adjusted for Grade 2 events; ACTG 175 required dose adjustment for Grade 2 peripheral neuropathy but recorded only Grade 3 events.</footnote> </td> <td styleCode="lrule botrule">28.3</td> <td styleCode="lrule botrule">13.0</td> <td styleCode="lrule botrule">3.1</td> <td styleCode="lrule botrule rrule">3.3</td> </tr> <tr> <td styleCode="lrule">Skin</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule botrule"> Rash/Pruritus/Urticaria</td> <td styleCode="lrule botrule">3.4</td> <td styleCode="lrule botrule">3.9</td> <td styleCode="lrule botrule">1.8</td> <td styleCode="lrule botrule rrule">1.6</td> </tr> <tr> <td styleCode="lrule">Metabolic and Nutrition</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule botrule"> Pancreatitis</td> <td styleCode="lrule botrule">0.0</td> <td styleCode="lrule botrule">1.7</td> <td styleCode="lrule botrule">0.2</td> <td styleCode="lrule botrule rrule">0.5</td> </tr> <tr> <td styleCode="lrule">Psychological</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule botrule"> Depression</td> <td styleCode="lrule botrule">0.4</td> <td styleCode="lrule botrule">0.0</td> <td styleCode="lrule botrule">1.1</td> <td styleCode="lrule botrule rrule">1.8</td> </tr> <tr> <td styleCode="lrule">Musculoskeletal</td> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule"/> <td styleCode="lrule rrule"/> </tr> <tr> <td styleCode="lrule botrule"> Painful/Swollen Joints</td> <td styleCode="lrule botrule">0.4</td> <td styleCode="lrule botrule">0.0</td> <td styleCode="lrule botrule">0.3</td> <td styleCode="lrule botrule rrule">1.0</td> </tr> </tbody> </table>

<table ID="t3" width="100%"> <caption>Table 3 Percentage of Patients With Laboratory Abnormalities &#x2014; Protocol Grade 3/4</caption> <col align="left" valign="top" width="40%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <col align="center" valign="top" width="15%"/> <thead> <tr> <th styleCode="lrule"/> <th colspan="2" styleCode="lrule">CPCRA 002<footnote ID="table3foot1">Grade 3 or higher reported for CPCRA 002.</footnote> ZDV Intolerant or Failure</th> <th colspan="2" styleCode="lrule rrule">ACTG 175 ZDV Naive/Experienced</th> </tr> <tr> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule">HIVID 0.750 mg q8h n=237</th> <th styleCode="lrule toprule">ddI 250 mg q12h n=230</th> <th styleCode="lrule toprule">ZDV 200 mg q8h n=619</th> <th styleCode="lrule toprule rrule">HIVID+ZDV 0.750 mg q8h +200 mg q8h n=615</th> </tr> <tr> <th styleCode="lrule toprule">Laboratory Abnormality</th> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule"/> <th styleCode="lrule toprule rrule"/> </tr> </thead> <tbody> <tr> <td styleCode="lrule">Anemia (&lt;7.5 gm/dL)</td> <td styleCode="lrule">8.4</td> <td styleCode="lrule">7.4</td> <td styleCode="lrule">1.8</td> <td styleCode="lrule rrule">3.1</td> </tr> <tr> <td styleCode="lrule">Leukopenia (&lt;1500 cells/mm³)</td> <td styleCode="lrule">13.1</td> <td styleCode="lrule">9.6</td> <td styleCode="lrule">N/A<footnote ID="FN1154109735-1">N/A Not available.</footnote> </td> <td styleCode="lrule rrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> </tr> <tr> <td styleCode="lrule">Eosinophilia (&gt;1000 cells/mm³ or 25%)</td> <td styleCode="lrule">2.5</td> <td styleCode="lrule">1.7</td> <td styleCode="lrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> <td styleCode="lrule rrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> </tr> <tr> <td styleCode="lrule">Neutropenia (&lt;750 cells/mm³)</td> <td styleCode="lrule">16.9</td> <td styleCode="lrule">11.7</td> <td styleCode="lrule">1.9</td> <td styleCode="lrule rrule">4.2</td> </tr> <tr> <td styleCode="lrule">Thrombocytopenia (&lt;50,000 cells/mm³)</td> <td styleCode="lrule">1.3</td> <td styleCode="lrule">4.8</td> <td styleCode="lrule">1.1</td> <td styleCode="lrule rrule">1.8</td> </tr> <tr> <td styleCode="lrule">CPK Elevation<footnoteRef IDREF="table3foot1"/> (&gt;4&#xD7; ULN)</td> <td styleCode="lrule">0.8</td> <td styleCode="lrule">0.0</td> <td styleCode="lrule">5.8</td> <td styleCode="lrule rrule">5.7</td> </tr> <tr> <td styleCode="lrule">ALT (SGPT) (&gt;5 &#xD7; ULN)</td> <td styleCode="lrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> <td styleCode="lrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> <td styleCode="lrule">3.6</td> <td styleCode="lrule rrule">5.0</td> </tr> <tr> <td styleCode="lrule">AST (SGOT) (&gt;5 &#xD7; ULN)</td> <td styleCode="lrule">7.6</td> <td styleCode="lrule">5.7</td> <td styleCode="lrule">2.9</td> <td styleCode="lrule rrule">4.1</td> </tr> <tr> <td styleCode="lrule">Bilirubin (&gt;2.5 &#xD7; ULN)</td> <td styleCode="lrule">0.8</td> <td styleCode="lrule">0.9</td> <td styleCode="lrule">0.5</td> <td styleCode="lrule rrule">1.0</td> </tr> <tr> <td styleCode="lrule">GGT (&gt;5 &#xD7; ULN)</td> <td styleCode="lrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> <td styleCode="lrule">N/A<footnoteRef IDREF="FN1154109735-1"/> </td> <td styleCode="lrule">0.5</td> <td styleCode="lrule rrule">1.0</td> </tr> <tr> <td styleCode="lrule">Amylase (&gt;2 &#xD7; ULN)</td> <td styleCode="lrule">5.1</td> <td styleCode="lrule">3.9</td> <td styleCode="lrule">1.0</td> <td styleCode="lrule rrule">1.5</td> </tr> <tr> <td styleCode="lrule">Hyperglycemia<footnoteRef IDREF="table3foot1"/> (&gt;250 mg/dL)</td> <td styleCode="lrule">0.0</td> <td styleCode="lrule">1.7</td> <td styleCode="lrule">0.8</td> <td styleCode="lrule rrule">2.0</td> </tr> </tbody> </table>