Geographic location of antiretroviral clinical trials in HIV infected pediatric patients.

BACKGROUND

Some medicines regulatory authorities are encouraging research in pediatrics. However, children are a vulnerable population, and previous studies have suggested that research is increasingly being conducted outside of developed countries.

OBJECTIVE

The purpose of this study is to determine the location of trials in the pediatric population with human immunodeficiency virus (HIV).

SETTING

Not applicable.

METHODS

Clinical trials registered in the largest international clinical trials registry (clinicaltrials.gov) evaluating antiretrovirals in pediatric HIV infected patients were included. Data were collected on the location, funding, study purpose, design, initiation date, age of subjects, and medication classes tested.

MAIN OUTCOME MEASURES

We assessed frequencies of characteristics of pediatric HIV trials registered in the clinicaltrials.gov database.

RESULTS

Overall, 288 studies were included in the analysis. Most trials were conducted in ages 12-17 years (83 %), followed by studies in those <6 years (25 %) and 6-11 years (21 %). The location of most trials included at least one site in developed countries (83 %). The number of trials completed exclusively in developing countries increased from 1989 to 2011.

CONCLUSIONS

The majority of pediatric antiretroviral trials registered in clinicaltrials.gov were conducted in adolescent subjects in developed countries. The number of pediatric HIV studies in developing countries increased while studies conducted in developed countries decreased similar to trends of HIV.