Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117728
Status:
UNKNOWN
Last Update Posted:
2007-06-29
First Post:
2005-07-06
Brief Title:
Pediatric Nevirapine Resistance Study
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Clinical Relevance of Nevirapine Resistance
Status:
UNKNOWN
Status Verified Date:
2006-01
Last Known Status:
RECRUITING
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 is designed to test if a sequential protease-inhibitor PI - nevirapine NVP -based regimen is effective for the treatment of HIV-infected children when previous NVP exposure has occurred as part of programs to prevent mother-to-child transmission pMTCT
Detailed Description:
The wide use of NVP in pMTCT-prophylaxis may result in resistance to NNRTI and concomitantly limits the use of these drugs for the treatment of HIV-infected children To avoid restricting treatment options for children it is desirable to preserve NVP for both pMTCT and first line treatment This study will therefore test whether resistance-caused treatment failures of HIV-infected and previously NVP-exposed children can be avoided if the NVP treatment is preceded by an initial PI-based regimen
Comparison HIV-infected children less than 24 months of age exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups 1 to continue on PI-containing regimen or 2 to be switched off the PI-containing regimen onto the NVP-containing regimen The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization
Comparison HIV-infected children less than 24 months of age exposed to any pMTCT regimen that included NVP and who achieve and maintain viral suppression for at least 3 months with a PI-based regimen will be randomized to one of the two groups 1 to continue on PI-containing regimen or 2 to be switched off the PI-containing regimen onto the NVP-containing regimen The study outcome will be proportions in the two groups who have complete virologic suppression at 6 months after randomization
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