Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000851
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Trial of Stavudine d4T Plus Didanosine ddI in Children on Long-Term Stavudine Monotherapy and Stavudine Versus Stavudine Plus Didanosine in Children on Long-Term Zidovudine Monotherapy A Rollover Protocol for ACTG 240 Participants and Children Receiving Prescription Zidovudine
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To evaluate the safety and determine the pharmacokinetic disposition of stavudine d4T alone and in combination with didanosine ddI and whether concurrent administration alters the disposition of either drug To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations To determine the relationship if any between drug exposure and viral burden
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks the three children with baseline counts greater than 50 cellsmicro liter experienced a 20 increase in their CD4 lymphocyte counts Based on these results controlled trials of the same regimen for children with less advanced HIV disease should be undertaken
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks the three children with baseline counts greater than 50 cellsmicro liter experienced a 20 increase in their CD4 lymphocyte counts Based on these results controlled trials of the same regimen for children with less advanced HIV disease should be undertaken
Detailed Description:
In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks the three children with baseline counts greater than 50 cellsmicro liter experienced a 20 increase in their CD4 lymphocyte counts Based on these results controlled trials of the same regimen for children with less advanced HIV disease should be undertaken
Eligible subjects receiving d4T will be assigned in an open manner to Arm 1 and subjects who have been receiving zidovudine AZT will be assigned in a randomized double blind manner to Arms 2 and 3 Each subject will receive study drug for 48 weeks as follows Arm 1 - d4T plus ddI Arm 2 - d4T alone Arm 3 - d4T plus ddI
Eligible subjects receiving d4T will be assigned in an open manner to Arm 1 and subjects who have been receiving zidovudine AZT will be assigned in a randomized double blind manner to Arms 2 and 3 Each subject will receive study drug for 48 weeks as follows Arm 1 - d4T plus ddI Arm 2 - d4T alone Arm 3 - d4T plus ddI
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 |
|---|---|---|---|
| 11300 | REGISTRY | DAIDS ES Registry Number | None |