Research article

Effects of highly active antiretroviral therapy with nelfinavir in vertically HIV-1 infected children: 3 years of follow-up. Long-term response to nelfinavir in children

Salvador Resino¹ , Beatriz Larrú² , Jose Ma Bellón¹ , Rosa Resino¹ , Ma Isabel de José² , Marisa Navarro³ , Juan Antonio Léon⁴ , José Tomás Ramos⁵ , Ma José Mellado⁶ and Ma Ángeles Muñoz-Fernández¹

¹Laboratorio de Inmuno-Biología Molecular, Hospital General Universitario "Gregorio Marañón", Madrid, Spain

²Pediatría-Infecciosas, Hospital Universitario "La Paz", Madrid, Spain

³Pediatría-Infecciosas, Hospital General Universitario "Gregorio Marañón", Madrid, Spain

⁴Pediatría-Infecciosas, Hospital Universitario "Virgen de Rocío", Sevilla, Spain

⁵Inmuno-Pediatría, Hospital Universitario "12 de Octubre", Madrid, Spain

⁶Pediatría-Infecciosas, Hospital Universitario "Carlos III", Madrid, Spain

author email corresponding author email

BMC Infectious Diseases 2006, 6:107doi:10.1186/1471-2334-6-107

Published:	11 July 2006

Abstract

Background

Antiretroviral treatment (ART) in children has special features and consequently, results obtained from clinical trials with antiretroviral drugs in adults may not be representative of children. Nelfinavir (NFV) is an HIV-1 Protease Inhibitor (PI) which has become as one of the first choices of PI for ART in children. We studied during a 3-year follow-up period the effects of highly active antiretroviral therapy with nelfinavir in vertically HIV-1 infected children.

Methods

Forty-two vertically HIV-infected children on HAART with NFV were involved in a multicentre prospective study. The children were monitored at least every 3 months with physical examinations, and blood sample collection to measure viral load (VL) and CD4+ cell count. We performed a logistic regression analysis to determinate the odds ratio of baseline characteristics on therapeutic failure.

Results

Very important increase in CD4+ was observed and VL decreased quickly and it remained low during the follow-up study. Children with CD4+ <25% at baseline achieved CD4+ >25% at 9 months of follow-up. HIV-infected children who achieved undetectable viral load (uVL) were less than 40% in each visit during follow-up. Nevertheless, HIV-infected children with VL >5000 copies/ml were less than 50% during the follow-up study. Only baseline VL was an important factor to predict VL control during follow-up. Virological failure at defined end-point was confirmed in 30/42 patients. Along the whole of follow-up, 16/42 children stopped HAART with NFV. Baseline characteristics were not associated with therapeutic change.

Conclusion

NFV is a safe drug with a good profile and able to achieve an adequate response in children.