Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001032
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Dideoxycytidine Plus Zidovudine AZT in HIV-Infected Children Who Have Taken AZT
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Study to Evaluate Pharmacokinetics Safety Tolerance and Activity of Dideoxycytidine ddC Administered in Combination With Zidovudine AZT in Stable AZT-Treated Pediatric Patients With HIV Infection
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:
PRIMARY To determine safety tolerance and pharmacokinetics of zidovudine AZT and zalcitabine dideoxycytidine ddC when given in combination in clinically stable AZT-treated children
SECONDARY To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression as determined by virologic and immunologic determinations To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria
In children currently being treated with AZT it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance This study will examine the possible advantages of combination AZTddC therapy over monotherapy with AZT alone
SECONDARY To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression as determined by virologic and immunologic determinations To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria
In children currently being treated with AZT it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance This study will examine the possible advantages of combination AZTddC therapy over monotherapy with AZT alone
Detailed Description:
In children currently being treated with AZT it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance This study will examine the possible advantages of combination AZTddC therapy over monotherapy with AZT alone
Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC Patients receive therapy until the last patient enrolled completes 32 weeks of therapy The study may be extended for two additional 32-week periods on an optional basis
Patients are stratified according to duration of ongoing AZT therapy and are randomized to receive AZT either alone or in combination with ddC Patients receive therapy until the last patient enrolled completes 32 weeks of therapy The study may be extended for two additional 32-week periods on an optional basis
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11165 | REGISTRY | DAIDS ES Registry Number | None |