Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234091
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2005-10-04
Brief Title:
When to Start Anti-HIV Drugs in Children Infected With HIV The PREDICT Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open Label Randomized Study to Compare Antiretroviral Therapy ART Initiation When CD4 is Between 15 to 24 to ART Initiation When CD4 Falls Below 15 in Children With HIV Infection and Moderate Immune Suppression
Status:
COMPLETED
Status Verified Date:
2013-12
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:
The purpose of this study is to determine when HIV infected children should begin taking anti-HIV medications in order to improve both patient quality of life and survival
Detailed Description:
The use of highly active antiretroviral therapy HAART has resulted in a significant reduction in AIDS-related deaths and complications among adults and adolescents However the medical management of HIV infected children remains challenging Access to HIV treatment is limited and early treatment initiation can cause serious complications Since there is currently no cure for HIV a balance between treating the disease and maintaining quality of life must be weighed carefully An evaluation to determine the appropriate time to initiate HAART is necessary to improve both quality of life and survival for HIV infected children
This study will last 144 weeks All participants will have a CD4 percentage CD4 between 15 and 24 and will be randomly assigned to either receive immediate or delayed HAART The HAART regimen will consist of two nucleoside reverse transcriptase inhibitors zidovudine and lamivudine In addition participants will also receive either one non-nucleoside reverse transcriptase inhibitor nevirapine or efavirenz or one protease inhibitor ritonavir-boosted lopinavir or nelfinavir Abacavir will replace zidovudine or lamivudine if participants experience toxicity to the regimen Participants in the immediate treatment arm will receive HAART on Day 1 of the study regardless of their CD4 Participants in the delayed treatment arm will receive HAART if their CD4 falls below 15 or if they develop a CDC Category C illness
Study visits will occur every 4 weeks for the first 12 weeks and then every 12 weeks until the end of the study Blood collection physical exams and medical and medication history reviews will occur at all visits Adherence quality of life and lipodystrophy assessments will occur every 12 weeks for participants on HAART Participants will be encouraged to enroll in a related substudy to examine the neurodevelopment of HIV infected children
This study will last 144 weeks All participants will have a CD4 percentage CD4 between 15 and 24 and will be randomly assigned to either receive immediate or delayed HAART The HAART regimen will consist of two nucleoside reverse transcriptase inhibitors zidovudine and lamivudine In addition participants will also receive either one non-nucleoside reverse transcriptase inhibitor nevirapine or efavirenz or one protease inhibitor ritonavir-boosted lopinavir or nelfinavir Abacavir will replace zidovudine or lamivudine if participants experience toxicity to the regimen Participants in the immediate treatment arm will receive HAART on Day 1 of the study regardless of their CD4 Participants in the delayed treatment arm will receive HAART if their CD4 falls below 15 or if they develop a CDC Category C illness
Study visits will occur every 4 weeks for the first 12 weeks and then every 12 weeks until the end of the study Blood collection physical exams and medical and medication history reviews will occur at all visits Adherence quality of life and lipodystrophy assessments will occur every 12 weeks for participants on HAART Participants will be encouraged to enroll in a related substudy to examine the neurodevelopment of HIV infected children
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 |
|---|---|---|---|
| 10409 | REGISTRY | DAIDS ES | None |
| PREDICT | None | None | None |