Comparison of Liquid Kaletra and Low Dose Kaletra Tablets
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective
medications that are approved and available for young children who are HIV+. The liquid form
is reported to have a very nasty taste and presents difficulties for the children who must
take the medication twice a day and for their parents who must enforce the medication
regimen. The children are often well into their teens before they weigh enough to be able to
take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now
available. However, it is not known if the liquid and tablet act the same in children. The
purpose of this study is to switch children from the baseline treatment with the liquid to
the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will
compare children pre-switch and post-switch in terms of how well their HIV is controlled .
Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children
currently well managed with a medications including liquid Kaletra will be invited to switch
from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a
satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At
the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the
parent and/or child will complete the satisfaction survey. In addition, at the switch and 1
month post switch, a day will be spent in clinic with 5 blood draws to see how much of the
drug is in the blood stream at different times after the medicine is taken.