HIV Infections Clinical Trial
Official title:
IMPAACT P1058A: Intensive Pharmacokinetic Studies of New Classes of Antiretroviral Drug Combinations in Children, Adolescents and Young Adults
This study will examine drug and body interactions in children receiving anti-HIV treatment regimens using new medications. Drug regimens to be examined will feature the medications raltegravir (RAL), maraviroc (MVC), and etravirine (ETV). These drugs will not be provided through the study.
Antiretroviral (ARV) medication regimens for children, adolescents and young adults are
often prescribed based on drug resistance because of previous treatment history. In order to
find an effective regimen, clinicians must often turn to newer drugs before they have been
fully tested in adolescent or pediatric clinical trials. One of the first steps in testing
these drugs is to assess the drug pharmacokinetics (PK), or interaction between drugs and
body. This study, a follow-on protocol to the International Maternal Pediatric Adolescent
AIDS Clinical Trials Group (IMPAACT) P1058 study, will test children, adolescents and young
adults who have already been prescribed treatment regimens with new drugs. The study will
examine the PK of medication combinations featuring raltegravir, a new drug in the new ARV
class of entry inhibitors (EIs); maraviroc, a new drug in the new class of fusion inhibitors
(FIs); and etravirine, a new drug in the class of non-nucleoside reverse transcriptase
inhibitors (NNRTIs). Older medications may also be used to complete these regimens.
Participation in this study will last between 1 and 7 weeks and involve at least two clinic
visits. The first is a screening and entry visit at which a medical history will be taken
and a physical exam and blood test will be completed. The second visit will measure PK of
the medications. During this visit, participants will complete the same measures as
before—medical history, physical exam, blood test—and then be given a dose of their anti-HIV
medication regimen. After receiving the medications, participants will be monitored and give
blood samples after 1, 2, 4, 6, 8, and 12 hours. For Groups G, H, I, J, K and L an intensive
12-hour PK study will be scheduled after at least 30 days on the combination of interest.
For all Groups, the intensive 12-hour PK study should be performed within 35 days (5 weeks)
of screening/entry evaluations. Medications will not be provided through this study.
Results of the 12-hour medication monitoring tests will be delivered to participants'
physicians within 6 weeks. If, based on these results, a physician decides to change the
dosage of a participant's medication, that participant may be asked to complete a second PK
visit. Participants must have received the revised dose for at least 14 days before the PK
study can be repeated.
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