Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001818
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Combination Drug Treatment of Pediatric HIV Infection
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Hydroxyurea in Combination With Stavudine Didanosine and Efavirenz in Pediatric Patients With HIV-1 Infection
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 bodys 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
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
Detailed Description:
This is a pilot study to determine the safety toxicity virologic and immunologic effects of combination therapy with hydroxyurea a cytostatic chemotherapeutic agent two nucleoside reverse transcriptase inhibitors and a non-nucleoside reverse transcriptase inhibitor in children with HIV infection We will enroll HIV-infected children who have detectable viral loads greater than 10000 copiesml Patients will be stratified upon enrollment by CD4 cell count less than or greater than 200 CD4 cellsmm3 Two dose levels of hydroxyurea will be utilized 75 mgkgdose twice daily and 125 mgkgdose twice daily It is anticipated that 15 patients will be enrolled at the Low Dose Level and 10 patients at the High Dose Level of hydroxyurea within each CD4 cohort for a total of 50 patients on study Within each dose level patients will receive the antiretroviral agents didanosine stavudine and efavirenz beginning on study Day one and will be randomized to receive hydroxyurea either on Day 1 or week 6 The cohorts will be escalated and analyzed separately The study duration will be 52 weeks This study will attempt to define an effective and tolerable dose of hydroxyurea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-C-0118 | None | None | None |