Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000924
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Compare Two Different Anti-HIV Drug Regimens
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 Randomized Multicenter Protocol Evaluating Two 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:
This study compares 2 different anti-HIV drug regimens to determine which is the most effective in lowering the amount of HIV in the blood The anti-HIV drugs used in this study are 2 protease inhibitors nelfinavir and ritonavir 2 nucleoside reverse transcriptase inhibitors stavudine and didanosine and 1 nonnucleoside reverse transcriptase inhibitor nevirapine
These drug combinations have been previously studied in adults but there is limited information on how well they work in HIV-infected children It is important to develop drug combinations which are effective at suppressing the HIV virus in children
These drug combinations have been previously studied in adults but there is limited information on how well they work in HIV-infected children It is important to develop drug combinations which are effective at suppressing the HIV virus in children
Detailed Description:
The use of combination therapy with 2 or more antiretroviral agents has been strongly supported by recent studies in both children and adults However as of yet few combinations of antiretrovirals have been studied in large cohorts of stable HIV-1 infected antiretroviral-experienced children Evidence suggests that viral suppression may be more difficult to achieve in children Therefore it is important to develop new drug combinations which can maximally suppress plasma HIV-1 RNA concentrations in children
Patients are stratified by prior antiretroviral treatment zidovudine ZDVlamivudine 3TC versus d4Tother treatment and by age under 24 months versus 24 months and older Patients are then randomized to 1 of 4 treatment groups
Arm A1 ddINFVRTV for prior ZDV3TC-treated patients Arm A2 ddINFVRTV for prior d4Tother-treated patients Arm B1 d4TNFVNVP for prior ZDV3TC-treated patients Arm B2 d4TNFVNVP for prior d4Tother-treated patients Treatment is administered for 48 weeks At Weeks 2 4 and then every 4 weeks thereafter patients undergo physical examinations and blood samples are drawn to measure viral load AS PER AMENDMENT 42700 Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks While on the treatment extension patients must continue their current schedule for study drug administration and completion of study visits Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study
Patients are stratified by prior antiretroviral treatment zidovudine ZDVlamivudine 3TC versus d4Tother treatment and by age under 24 months versus 24 months and older Patients are then randomized to 1 of 4 treatment groups
Arm A1 ddINFVRTV for prior ZDV3TC-treated patients Arm A2 ddINFVRTV for prior d4Tother-treated patients Arm B1 d4TNFVNVP for prior ZDV3TC-treated patients Arm B2 d4TNFVNVP for prior d4Tother-treated patients Treatment is administered for 48 weeks At Weeks 2 4 and then every 4 weeks thereafter patients undergo physical examinations and blood samples are drawn to measure viral load AS PER AMENDMENT 42700 Patients in Arms A1 and A2 may continue to receive medication for an additional 24 weeks While on the treatment extension patients must continue their current schedule for study drug administration and completion of study visits Patients in Arms A1 and A2 who have reached Week 44 participate in an enteric-coated ddI pharmacokinetic study as part of this 24-week extension Patients who were enrolled in Arms A1 or A2 and who were taken off study after reaching Week 48 may be re-entered onto the study at Week 52 regardless of the number of weeks they have been off study
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 |
|---|---|---|---|
| PACTG 403 | Registry Identifier | DAIDS ES | None |
| 11358 | REGISTRY | None | None |
| P1001S substudy | None | None | None |
| P1004S substudy | None | None | None |