Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001091
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Safety and Effectiveness of Four Anti-HIV Drug Combinations in HIV-Infected Children and Teens
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 Rolling Arm Master Protocol PRAM of Novel Antiretroviral Therapy in Stable Experienced HIV-Infected Children PRAM-2 A Phase III Randomized Multicenter Protocol Comparing Four Antiretroviral Regimens Containing Combinations of Protease Inhibitors NRTIs and an NNRTI
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:
The purpose of this study is to see if it is safe and effective to give HIV-infected children and teens 1 of 4 anti-HIV drug combinations
Decreasing HIV levels in infected patients can slow down disease progression Further study is needed to find out which drug combinations are most effective in doing this
Decreasing HIV levels in infected patients can slow down disease progression Further study is needed to find out which drug combinations are most effective in doing this
Detailed Description:
For PRAM 2 Evidence suggests that as a consequence of antiviral therapy decreases in plasma HIV-1 RNA are strongly associated with a delay in clinical progression Therefore the drug regimens proposed in this study are designed to result in a much larger sustained drop in plasma HIV-1 RNA and greater clinical benefit Further intent of this study is to evaluate the virologic and therapeutic potential of novel combinations of antiretrovirals and to better define the pharmacokinetics and drug-drug interactions of therapies included in this regimen
The Master PRAM schema is designed to allow new therapeutic arms to be studied as rolling screens through multiple generations of PRAMs There is a common linking regimen between any 2 sequential PRAM generations that will permit an indirect comparison of included therapies NOTE Due to significant changes in study design between PRAM 1 and PRAM 2 there is no linking arm between them The linkage will be reinstated from PRAM 2 and subsequent PRAM generations The therapeutic potential of the treatment arms is assessed by their ability to decrease HIV copy numbers as defined by plasma HIV-1 RNA copy number Once accrual to a PRAM is complete a new treatment comparison will open for accrual
For PRAM 2 This study will compare the following 4 treatment arms
Arm A - stavudine d4Tnevirapineritonavir Arm B - d4Tlamivudine 3TCnelfinavir Arm C - d4Tnevirapinenelfinavir Arm D - d4T3TCnevirapinenelfinavir Prior to randomization to 1 of the PRAM 2 treatment arms patients are stratified based on their CD4 less than 25 and greater than or equal to 25 and by age less than 24 months and greater than or equal to 24 months The first 35 subjectstreatment arm are evaluated with special immunologic studies including lymphoproliferative assays and extended panel immunophenotyping There is an interim analysis after all patients have completed 12 weeks of treatment Patients are treated for 48 weeks AS PER AMENDMENT 61199 The study has been extended for an additional 48 weeks 96 weeks total to permit long-term follow-up of clinically stable HIV-infected children
The Master PRAM schema is designed to allow new therapeutic arms to be studied as rolling screens through multiple generations of PRAMs There is a common linking regimen between any 2 sequential PRAM generations that will permit an indirect comparison of included therapies NOTE Due to significant changes in study design between PRAM 1 and PRAM 2 there is no linking arm between them The linkage will be reinstated from PRAM 2 and subsequent PRAM generations The therapeutic potential of the treatment arms is assessed by their ability to decrease HIV copy numbers as defined by plasma HIV-1 RNA copy number Once accrual to a PRAM is complete a new treatment comparison will open for accrual
For PRAM 2 This study will compare the following 4 treatment arms
Arm A - stavudine d4Tnevirapineritonavir Arm B - d4Tlamivudine 3TCnelfinavir Arm C - d4Tnevirapinenelfinavir Arm D - d4T3TCnevirapinenelfinavir Prior to randomization to 1 of the PRAM 2 treatment arms patients are stratified based on their CD4 less than 25 and greater than or equal to 25 and by age less than 24 months and greater than or equal to 24 months The first 35 subjectstreatment arm are evaluated with special immunologic studies including lymphoproliferative assays and extended panel immunophenotyping There is an interim analysis after all patients have completed 12 weeks of treatment Patients are treated for 48 weeks AS PER AMENDMENT 61199 The study has been extended for an additional 48 weeks 96 weeks total to permit long-term follow-up of clinically stable 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 |
|---|---|---|---|
| PACTG 377 | Registry Identifier | DAIDS ES | None |
| 11338 | REGISTRY | None | None |