Open Access Highly Accessed Research article

Five-year follow-up of children with perinatal HIV-1 infection receiving early highly active antiretroviral therapy

Elena Chiappini1, Luisa Galli1, Pier-Angelo Tovo2, Clara Gabiano2, Catiuscia Lisi3, Stefania Bernardi4, Alessandra Viganò5, Alfredo Guarino6, Carlo Giaquinto7, Susanna Esposito8, Raffaele Badolato9, Cesare Di Bari10, Raffaella Rosso11, Orazio Genovese12, Massimo Masi13, Antonio Mazza14 and Maurizio de Martino1*

Author Affiliations

1 Department of Pediatrics, University of Florence, Florence, Italy

2 Department of Pediatrics, University of Turin, Turin, Italy

3 Department of Statistics, University of Florence, Florence, Italy

4 Pediatric Clinic, "Bambino Gesù" Hospital, Rome, Italy

5 Infectious Diseases Unit- Department of Paediatrics, "L. Sacco" Hospital, University of Milan, Milan, Italy

6 Department of Pediatrics, "Federico II" University, Naples, Italy

7 Department of Pediatrics, Padua University, Padua, Italy

8 Department of Maternal and Pediatric Sciences," Milan University, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagali e Regina Elena, Milan, Italy

9 Pediatric Clinic, Brescia University, Brescia, Italy

10 Clinic of Infectious Diseases, " Giovanni XXIII" Pediatric Hospital, Bari, Italy

11 Infectious Diseases Clinic, University of Genoa, San Martino Hospital, Genoa, Italy

12 Pediatric Intensive Unit, Gemelli Hospital, Rome, Italy

13 Pediatric Clinic, "S. Orsola" Hospital, Bologna University, Bologna, Italy

14 Paediatic Unit, "S. Chiara" Hospital, Trento, Italy

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BMC Infectious Diseases 2009, 9:140  doi:10.1186/1471-2334-9-140

Published: 26 August 2009



Early highly active antiretroviral therapy (HAART), started within the first months of age, has been proven to be the optimal strategy to prevent immunological and clinical deterioration in perinatally HIV-infected children. Nevertheless, data about long-term follow-up of early treated children are lacking.


We report data from 40 perinatally HIV-infected-children receiving early HAART, with a median follow-up period of 5.96 years (interquartile range [IQR]:4.21–7.62). Children were enrolled at birth in the Italian Register for HIV Infection in Children. Comparison with 91 infected children born in the same period, followed-up from birth, and receiving deferred treatment was also provided.


Nineteen children (47.5%) were still receiving their first HAART regimen at last follow-up. In the remaining children the first regimen was discontinued, after a median period of 3.77 years (IQR: 1.71–5.71) because of viral failure (8 cases), liver toxicity (1 case), structured therapy interruption (3 cases), or simplification/switch to a PI-sparing regimen (9 cases). Thirty-nine (97.5%) children showed CD4+ T-lymphocyte values>25%, and undetectable viral load was reached in 31 (77.5%) children at last visit. Early treated children displayed significantly lower viral load than not-early treated children, until 6 years of age, and higher median CD4+ T-lymphocyte percentages until 4 years of age. Twenty-seven (29.7%) not-early treated vs. 0/40 early treated children were in clinical category C at last follow-up (P < 0.0001).


Our findings suggest that clinical, virologic and immunological advantages from early-HAART are long-lasting. Recommendations indicating the long-term management of early treated children are needed.