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. Author manuscript; available in PMC: 2011 Apr 14.
Published in final edited form as: N Engl J Med. 2010 Oct 14;363(16):1499–1509. doi: 10.1056/NEJMoa0906626

Table 3.

Signs and Symptoms, Laboratory Abnormalities, New Diagnoses, and Lipid Results in Trial 1.*

Variable Nevirapine (N = 121) Ritonavir-Boosted Lopinavir (N = 120) Total (N = 241) Unadjusted P Value‡
Grade 3 or higher sign or symptom — no. (%)† 17 (14) 13 (11) 30 (12) 0.56
 General (pain, fatigue, weight loss, fever) — no. 9 7 16
 Gastrointestinal (diarrhea, nausea, or vomiting) — no. 5 3 8
 Cough or dyspnea — no. 2 3 5
 Cardiovascular dysfunction — no. 2 1 3
 Hepatic — no. 1 0 1
Grade 3 or higher laboratory abnormality — no. (%)† 32 (26) 26 (22) 58 (24) 0.45
 Creatinine >1.8 times upper limit of normal 1 2 3
 Sodium >154 or <125 mmol/liter 3 5 8
 Potassium >6.5 or <2.5 mmol/liter 1 2 3
 Liver enzymes 13 4 17
 Aspartate aminotransferase >5 times upper limit of normal 6 3 9
 Alanine aminotransferase >5 times upper limit of normal 10 2 12
 Total bilirubin >2.5 times upper limit of normal 2 0 2
 Hematologic abnormality 12 16 28
 Platelets count <50,000/mm3 0 1 1
 Hemoglobin <7.5 g/dl 3 5 8
 Absolute neutrophil count <750/mm3 10 11 21
No. of participants with new diagnoses 73 75 148 0.79
Change in lipids from baseline to 48 wk (mg/dl)
 Total cholesterol 21.0±3.3 25.1±3.0 0.35
 HDL cholesterol 17.6±1.7 10.7±1.5 0.002
 LDL cholesterol 6.7±2.9 13.1±2.6 0.10
 Triglycerides −14.1±5.4 16.5±8.6 0.006
*

Plus–minus values are means ±SE. Participants may have had more than one event.

†

Grading was performed with the use of the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, December 2004.

‡

P values for the comparison between the two treatment groups are shown. Those for the changes in lipids were calculated by means of the linear regression model; all other P values were obtained with the use of Fisher’s exact test.