Triple therapy containing nelfinavir in HIV infected children

The aim of the study was to appreciate the efficacy of different combinations containing nelfinavir (NFV) in HIV-infected children. We have performed a retrospective study of 28 HIV infected children who received antiretroviral regimen containing NFV for 12 months. Patients' monitoring was made by clinical and biological means. We measured the HIV RNA levels at the beginning of the study, after 3 and 12 months. In this combination we used NFV and two nucleoside reverse transcriptase inhibitors (NRTI): zidovudine (ZDV) + lamivudine (3TC) - five cases; ZDV + zalcitabine (ddC) - one case; stavudine (d4T) - 3TC - 20 cases. One child received ZDV + efavirenz + NFV. We have studied 28 HIV infected children. Fifteen (53.5%) patients were girls. The mean age at the beginning of the study was 10.5 years. Most of the patients had moderate immunodepression; mean CD4 level was 341 cells/mm super(3). In all cases we noticed clinical improvement. We observed no opportunistic infection. The mean CD4 level after 12 months was 418 cells/mm super(3). The CD4 level increase was 77 cells/mm super(3). From five (17.8%) cases of naive patients, one (3.5%) experienced antiretroviral therapy failure; viral load at 6 months was 577 000 copies/ml. In one (3.5%) case the treatment was stopped because of lipodystrophy. The other three (10.7%) naive children had undetectable viral load at 12 months. Twenty-three (82.2%) children were pretreated with two NRTI (ZDV+3TC or ZDV+ddC). Twelve (42.8%) patients had undetectable viral loads at 12 months. In 10 (35.7%) patients we noticed reductions in the plasma viral load below 10 000 copies/ml. In one case (3.5%) HIV RNA was 198 000 copies/ml after 12 months. In two cases (7.1%) we stopped the therapy because of gastrointestinal adverse events. We have studied 28 children treated with combinations of antiretroviral drugs containing nelfinavir. Twenty-seven patients received NFV+ 2 NRTI. One case was treated with NFV+ZDV+ EFV. In 53.5% cases we obtained durable suppression of viral load over 12 months. The treatment failure was noticed in 42.8% cases. The triple therapy was stopped in 10.7% cases because of adverse reactions (lipodystrophy, diarrhea). The tolerability of the regimen was good. There was no fatal adverse reaction.