Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000902
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study on the Management of Combination Anti-HIV Drug Therapy in HIV-Positive Children With Prior Treatment
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
RAD-1 A Phase III Antiretroviral Management Algorithm for Pediatric Subjects of Four-Drug Combination Therapies Based on Prior Antiretroviral Experience
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 determine the value of changing anti-HIV medications in children with progressive HIV disease who have received previous treatment
Plasma viral load the level of HIV in the blood is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development Changing the medications may enhance the results of treatment
Plasma viral load the level of HIV in the blood is probably most effectively reduced by giving patients anti-HIV drugs which affect the virus at various stages of development Changing the medications may enhance the results of treatment
Detailed Description:
The Master RAD Protocol is based on the concept that optimal suppression of viral load in vivo will be achieved in patients with rapidly progressing or advanced HIV disease RAD using antiretroviral combinations inhibiting viral replication at distinct sites of action Antiretroviral combinations are chosen with the hypothesis that simultaneous change to as many new agents as possible is necessary to maximally reduce plasma viral load
In this open-label multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors stavudine lamivudine zidovudine didanosine zalcitabine plus nevirapine NVP nelfinavir NFV or ritonavir RTV Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP NFV or RTV
Prior to randomization to a NFV- or RTV-containing regimen patients are stratified by HIV RNA greater than or equal to 50000 or less than 50000 and must able to receive 2 or more novel drugs
In this open-label multicenter study patients are randomized into 1 of 4 groups based on prior antiretroviral experience Each regimen consists of 4 drugs that include a combination of nucleoside reverse transcriptase inhibitors stavudine lamivudine zidovudine didanosine zalcitabine plus nevirapine NVP nelfinavir NFV or ritonavir RTV Patients must be naive to at least 2 of the 4 drugs in the regimen and at least 1 of the novel drugs must be NVP NFV or RTV
Prior to randomization to a NFV- or RTV-containing regimen patients are stratified by HIV RNA greater than or equal to 50000 or less than 50000 and must able to receive 2 or more novel drugs
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 |
|---|---|---|---|
| 11329 | REGISTRY | DAIDS ES | None |