Combination Drug Treatment of Pediatric HIV Infection
Status:
Completed
Trial end date:
2001-11-01
Target enrollment:
Participant gender:
Summary
This study will test the safety and effectiveness of hydroxyurea, an anti-cancer drug, given
together with the anti-HIV drugs didanosine, stavudine and efavirenz for treating children
infected with human immunodeficiency virus (HIV). Some studies have found that hydroxyurea
may help certain anti-HIV drugs to work better and that the virus does not become resistant
to it, as it does other drugs. This study will also examine how hydroxyurea affects the
body's immune system and virus levels.
Patients 3 through 21 years old with HIV infection may be eligible for this 52-week study.
They will be screened for eligibility with a thorough physical examination, including chest
X-ray, electrocardiogram and echocardiogram, head CT scan, eye examination and blood tests.
All patients in the study will take didanosine twice a day, stavudine twice a day and
efavirenz once a day. All patients will also take hydroxyurea twice a day, but some will take
a low dose of the drug, while others will take a high dose. Within each of these two groups
(high and low dose) some patients will start taking hydroxyurea the same day they begin the
anti-HIV drugs; others will not start hydroxyurea until after they have taken the anti-HIV
drugs for 5 weeks. Patients will have a physical examination every 3 weeks until week 12,
then every 4 weeks until week 24, and then every 8 weeks until the end of the study. Blood
tests to measure virus levels will be done every other day for the first 7 days and
periodically after that. For the first 8 weeks after starting hydroxyurea, blood tests will
be done weekly. An eye examination, chest X-ray, electrocardiogram, and CT scans of the head
will be done about every 6 months.