Fixed dose combination of lamivudine, stavudine and nevirapine in the treatment of pediatric HIV infection: a preliminary report.

To assess efficacy and safety of fixed-dose combination (FDC) of lamivudine, stavudine and nevirapine in the treatment of pediatric HIV- infection, it was administered in the form of oral suspension (Group-A) or dispersible tablet (Group-B). Assessment of improvement in symptoms, CD4 count and adverse drug reactions was done every three months. Baseline CD4 count/mm3 in Group-A (n = 13) patients aged < or =1 yr, 1 to 5 yr and > or = 6 yr increased by 79, 152, 342, 988; 422.8, 514.2, 711.6, 832.6; and 205, 332.7, 516.8, 761.6 after 3, 6, 9 and 12 months of therapy, respectively. The corresponding baseline CD4 count/mm3 in Group-B (n = 8) patients in the three age categories increased by 370, 644.5 and 314 after 3 months, respectively. Improvement in the clinical category was observed in all the patients taking study medication, including weight gain; and decreased incidence of fever, diarrhea, infections and hospitalization. None of the patients had any drug-related adverse effect. Adherence to the regimen was < 95 % and there were no treatment failures.