Tenofovir Disoproxil Fumarate to Treat Pediatric HIV
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
This study will test the safety, side effects and antiviral activity of different doses of
tenofovir DF in children and adolescents with human immunodeficiency virus (HIV) infection.
Tenofovir DF belongs to a group of drugs called nucleotide analog reverse transcriptase
inhibitors. These drugs prevent the virus from replicating (making more copies of itself).
HIV becomes resistant to many drugs used to fight the virus and these drugs become
ineffective. In laboratory tests, tenofovir DF has remained effective against HIV longer than
other anti-HIV medicines, and when resistance does develop, the virus may still be sensitive
to other drugs.
HIV-infected children between the ages of 4 and 18 years who weigh at least 10 kg (22 pounds)
may be eligible for this study. They must be able to receive antiretroviral therapy and have
completed at least two previous antiretroviral courses of treatment without benefit.
Upon entering the study, participants will have physical, eye and neuropsychiatric
examinations, blood tests, including tests to determine what anti-HIV drugs the patient is
resistant to, an echocardiogram (echo), electrocardiogram (EKG), chest X-ray, head CT scan,
skin tests, and special tests to examine the bones. These physical exams and tests will be
repeated throughout the study to determine changes in health.
Participants will continue their current anti-HIV therapy for 2 weeks and then stop all
medicines for a 1-week 'washout' period. After the washout period, patients will begin taking
tenofovir DF. For the first 2 days on the drug, a small blood sample (1/2 teaspoon) will be
collected 11 times over a 48-hour period through. A heparin lock (a tube kept in place in a
vein) may be put in place to avoid multiple needle sticks. Blood samples will be collected
for another 4 days to measure how well tenofovir DF alone works against HIV before other
drugs are added to the treatment regimen. After these first 6 days, at least two other
anti-HIV drugs will be added. They will be selected based on the results of the earlier blood
tests for resistance and on the child's medication history.
After 3 days of combination therapy, patients will continue therapy on an outpatient basis.
They will be seen in the clinic every 4 weeks at the start of the study and then every 12
weeks for physical exams, lab tests and other procedures as needed. The study will last
approximately 48 weeks. Patients who benefit from therapy may be able to continue to receive
tenofovir DF from the drug company sponsor or as part of another study, or the protocol for
this study may be amended to lengthen the treatment period.