Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000814
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
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 compare the antiviral activity safety toxicity and steady-state pharmacokinetics of zidovudine didanosine and nevirapine used in combination in patients with HIV infection
The duration of clinical benefit from zidovudine AZT may be limited because of development of viral resistance to the drug Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance
The duration of clinical benefit from zidovudine AZT may be limited because of development of viral resistance to the drug Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance
Detailed Description:
The duration of clinical benefit from zidovudine AZT may be limited because of development of viral resistance to the drug Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance
In Stage 1 of the study a minimum of 22 patients are randomized to each of three treatment arms didanosine ddI plus AZT plus nevirapine NVP ddI plus AZT and ddI plus NVP After 12 weeks of treatment the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pgml AND fewer than two patients experience grade 4 rash Patients in Stage 1 continue treatment for an additional 36 weeks In Stage 2 additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered Stage 2 patients receive treatment for at least 48 weeks
AS PER AMENDMENT 021297 As of 22897 patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks until 63097 Patients will be unblinded on or about 52397
In Stage 1 of the study a minimum of 22 patients are randomized to each of three treatment arms didanosine ddI plus AZT plus nevirapine NVP ddI plus AZT and ddI plus NVP After 12 weeks of treatment the study proceeds to Stage 2 provided at least 40 percent of patients in Stage 1 show a reduction of at least 40 percent from baseline ICD p24 antigen of greater than or equal to 70 pgml AND fewer than two patients experience grade 4 rash Patients in Stage 1 continue treatment for an additional 36 weeks In Stage 2 additional patients are randomized to each original treatment regimen until a maximum of 130 patients per arm have been entered Stage 2 patients receive treatment for at least 48 weeks
AS PER AMENDMENT 021297 As of 22897 patients receiving study drugs will be offered blinded study drugs for an additional 16 weeks until 63097 Patients will be unblinded on or about 52397
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 |
|---|---|---|---|
| 11222 | REGISTRY | DAIDS ES Registry Number | None |