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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.