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.