Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000841
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Indinavir Sulfate Plus Zidovudine AZT Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Double-Blind Phase III Study of Indinavir Sulfate With Open-Label Zidovudine AZT and Lamivudine 3TC in Subjects With HIV Infection With CD4 Cell Counts 200 Cellsmm3 and 6 Months of Prior AZT 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:
To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine AZT and lamivudine 3TC in AIDS patients
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy the combination of indinavir sulfate with AZT and 3TC should be evaluated
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy the combination of indinavir sulfate with AZT and 3TC should be evaluated
Detailed Description:
Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy the combination of indinavir sulfate with AZT and 3TC should be evaluated
Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine d4T for AZT Patients are followed at weeks 4 8 16 24 32 40 and 48 and every 8 weeks thereafter up to week 96 AS PER 022597 AMENDMENT Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy An open label extension phase has been added for the period through 063097 Patients who had been randomized to AZT3TC are given the option of continuing on assigned ACTG 320 study drugs crossing over to open-label indinavir or permanently discontinuing all study therapies and going off study Patients who were randomized to AZT3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies It is strongly suggested that patients who were on AZT3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible AS PER 060697 AMENDMENT The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks but not beyond 093097 This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized AS PER 091597 AMENDMENT Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372
Patients are randomized to receive open-label AZT and 3TC with or without indinavir sulfate for at least 48 weeks Patients who develop intolerance to AZT or have progressive disease after 24 weeks on study may substitute stavudine d4T for AZT Patients are followed at weeks 4 8 16 24 32 40 and 48 and every 8 weeks thereafter up to week 96 AS PER 022597 AMENDMENT Accrual has been halted because interim analysis has shown triple therapy superior to double-agent therapy An open label extension phase has been added for the period through 063097 Patients who had been randomized to AZT3TC are given the option of continuing on assigned ACTG 320 study drugs crossing over to open-label indinavir or permanently discontinuing all study therapies and going off study Patients who were randomized to AZT3TC plus indinavir or who were crossed to such therapy are given the option of continuing their currently assigned therapies It is strongly suggested that patients who were on AZT3TC who wish to receive open-label indinavir consider changing the nucleoside analog component of their regimen if at all possible AS PER 060697 AMENDMENT The availability of the current ACTG 320 treatment has been further extended for approximately 12 additional weeks but not beyond 093097 This extension will allow patients to continue receiving study medications until ACTG 372 is open to accrual the rollover protocol for subjects originally randomized to the triple drug component of ACTG 320 or who are crossed over due to a confirmed study endpoint is finalized AS PER 091597 AMENDMENT Open-label therapy will be provided for no more than 90 days beyond the enrollment of the first subject on ACTG 372
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 |
|---|---|---|---|
| 11294 | REGISTRY | DAIDS ES Registry Number | None |