Parents’ attitudes to their HIV‐infected children being enrolled into a placebo‐controlled trial: the PENTA 1 trial

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. Method and 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 fiv