PENTA 1

Authors: Paediatric European Network for Treatment of AIDS (PENTA)

Published in: HIV Med. 1999;1(1):25-31

Objective The study aimed to explore the experience of parents/care-givers to their child’s participation in a European randomized trial of immediate (zidovudine) with deferred (placebo) antiretroviral treatment in asymptomatic children with vertically acquired HIV infection (PENTA 1 trial).

Design One hundred and thirty-three questionnaires were distributed to parents/care-givers (68% of children in the trial) through their paediatrician prior to unblinding the individual child’s therapy (zidovudine/placebo) and 84 (63% response rate) were returned.

Methods & Results Thirty-six (43%) parents described moderate (n = 30) or great (n = 6) interference with everyday life. This was more frequent among parents of children whose HIV disease progressed (P = 0.03, Fisher’s exact test) but was unrelated to ethnicity, country of origin, treatment allocated or adverse events. Invited comments suggested that concern about forgetting doses and the taste/volume of the trial medication contributed to interference with everyday life. Seventy-six (90%) parents considered information received during the trial adequate. The eight expressing dissatisfaction were recruited in the same country and five of them were among the eight (10%) who stated that they would not want to enroll their child in another trial.

Conclusions There is a need for adequate ongoing feedback about trial progress to participating families. With increasing use of complex antiretroviral regimens, innovative ways of helping families with adherence issues require development and evaluation

Authors: Paediatric European Network for Treatment of AIDS (PENTA)

Published in: AIDS. 1998;12(4):F1-8

Background Plasma HIV-1 RNA levels are high in vertically infected infants. Information in older children is limited, particularly in those who have not received antiretroviral therapy.

Objectives To describe the relationships between HIV-1 RNA, age and CD4 cell count in untreated vertically infected children.

Design HIV-1 RNA was measured in 70 children [median age, 3.5 years (range, 0.4-11.9 years); median CD4 cell count, 881 x 10(6)/l (interquartile range, 576-1347 x 10(6) cells/l)] enrolled in a randomized placebo-controlled trial comparing immediate with deferred zidovudine in asymptomatic or mildly symptomatic vertically infected children (PENTA-1 trial). Short-term variability was assessed by comparing HIV-1 RNA at -2 and 0 weeks (prior to randomization). The relationship between age and HIV-1 RNA, and CD4 cell countwas analysed using data from all children prior to randomization and sequential samples from 35 remaining on placebo for up to 105 weeks, by fitting mixed linear models.

Results The within-individual SD in viral load was 0.26 log10 copies/ml. The median plasma HIV-1 RNA at enrollment was 4.61 log10 (range, 2.3-6.56 log10 copies/ml), significantly higher in children aged < or = 2 years (median, 5.23 log10 copies/ml) than in those aged > 2 years (4.51 log10 copies/ml; P < 0.0001). Mean HIV-1 RNA fell by 0.38 log10 copies/ml per year up to 2 years of age, by 0.21 log10 copies/ml per year from 2 to 4 years of age, and by 0.03 log10 copies/ml per year from 4 to 6 years of age reaching a nadir of 4.25 log10 copies/ml at 6 years. Mean log10 CD4 cell count declined steadily with age and was not significantly correlated with HIV-1 RNA, although there was some evidence that the rate of log10 CD4 cell decline was negatively correlated with the initial rate of HIV-1 RNA decline. No mutations associated with resistance to zidovudine were observed.

Conclusions Age is a key factor in the interpretation of both viral load and CD4 cell count in vertically infected children.