Clinical and virologic response to combination treatment with indinavir, zidovudine, and lamivudine in children with human immunodeficiency virus-1 infection: A multicenter study in The Netherlands

Objective: To evaluate the clinical, immunologic, and virologic response to indinavir, zidovudine, and lamivudine in children with human immunodeficie ncy virus-1 (HIV-1) infection. Study design: Twenty-eight HIV-1 infected children (3 months to 16 years of age) with or without prior treatment with reverse-transcriptase inhibitors and a HIV-1 RNA >5000 copies/mL and/or a CD4 cell count less than the lowe r limit of the age-specific reference value were treated with indinavir, zi dovudine, and lamivudine. Pharmacokinetics of indinavir were determined in each child. Results: The combination treatment was well tolerated in the majority of pa tients. Clinical improvement was seen in all patients. After 6 months of th erapy, 70% of the patients had an HIV-1 RNA load below 500 copies/mL, where as 48%; of the children had a viral load below 40 copies/mL. Relative CD4 c ell counts in relation to the lower limit of the age-specific reference val ue increased significantly from a median value of 79% at baseline to 106% a fter 6 months of therapy. The doses of indinavir necessary to achieve area under the curve values comparable to adult values varied from 1250 mg/m(2)/ d to 2450 mg/m(2)/d. Conclusions: Highly active antiretroviral therapy consisting of indinavir, zidovudine, and lamivudine in children reduced HIV-1 RNA to less than 500 c opies/mL in 70% of the children within 6 months. Improved CD4 cell counts w ere observed in most patients, as was a better clinical condition (no invas ive or opportunistic infections, increased weight gain). Side effects of th e triple therapy were mild. Highly active antiretroviral therapy can be use d as successfully in children as in adults.