Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001086
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Phase II Placebo Controlled Trial of Abacavir ABC 1592U89 in Combination With Open-Label Indinavir Sulfate IDV and Efavirenz EFV DMP-266 in HIV-Infected Subjects With Nucleoside Analog Experience A Rollover Study for ACTG 320
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 virologic response between abacavir ABC 1592U89 regimens drug vs placebo and between the 2 dosing regimens BID vs TID with respect to the proportion of patients with plasma HIV RNA levels below the limit of detection AS PER AMENDMENT 82797 500 copiesml at week 16 To evaluate the safety and tolerance of the study arms AS PER AMENDMENT 31099 During the extension period compare the time to detectable viremia 2 consecutive plasma HIV RNA levels greater than or equal to 500 copiesml between ABC and placebo Therapeutically there is a need to explore potent alternative therapy for patients who have received or are currently receiving a double nucleoside analog combination including lamivudine 3TC a regimen that was proven to be clinically inferior to indinavir IDV when combined with zidovudine3TC in study ACTG 320 In order to produce and maintain a maximal antiviral response all patients in this study will receive 2 or 3 potent new agents ABC a nucleoside analog EFV a non-nucleoside reverse transcriptase inhibitor NNRTI and IDV a protease inhibitor Virologically the major question this protocol seeks to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to subsequent treatment It is unclear whether it is best to add a protease inhibitor either 1 an NNRTI at 1 of 2 doses or 2 an NNRTI at 1 of 2 doses plus a new nucleoside analog to achieve plasma HIV RNA levels that are below the limits of detection
Detailed Description:
Therapeutically there is a need to explore potent alternative therapy for patients who have received or are currently receiving a double nucleoside analog combination including lamivudine 3TC a regimen that was proven to be clinically inferior to indinavir IDV when combined with zidovudine3TC in study ACTG 320 In order to produce and maintain a maximal antiviral response all patients in this study will receive 2 or 3 potent new agents ABC a nucleoside analog EFV a non-nucleoside reverse transcriptase inhibitor NNRTI and IDV a protease inhibitor Virologically the major question this protocol seeks to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to subsequent treatment It is unclear whether it is best to add a protease inhibitor either 1 an NNRTI at 1 of 2 doses or 2 an NNRTI at 1 of 2 doses plus a new nucleoside analog to achieve plasma HIV RNA levels that are below the limits of detection
Prior to randomization patients are stratified by CD4 cell count cellsmm3 less than or equal to 50 versus greater than 50 and by ACTG 320 participation enrolled versus not enrolled Patients with greater than 50 CD4 cellsmm3 are randomized to 1 of 4 treatment arms Arms I II III or IV and patients with less than or equal to 50 CD4 cellsmm3 are randomized to 1 of 2 treatment arms Arms I and II All patients will be followed for 48 weeks beyond the enrollment of the last patient The regimens for the treatment arms are as follows Arm I - indinavir IDV plus EFV plus ABC placebo bid Arm II - IDV higher dose plus EFV lower dose plus ABC Arm III - IDV plus EFV plus ABC placebo and Arm IV - IDV higher dose plus EFV lower dose plus ABC If 15 week data indicates this is a reasonable dosing regimen the sample size in Arms III and IV will be expanded to include additional patients with a CD4 count greater than 50 cellsmm3 and allow for equal enrollment across all 4 treatment arms Those patients who roll over from ACTG 320 will be assigned to receive open-label treatment on Arm II and evaluated independently of the 4 treatment arms listed above
AS PER AMENDMENT 82797 Patients with 2 consecutive HIV RNA measurements at least 500 copiesml at week 16 or anytime thereafter are given the option to receive open-label treatment with IDV plus EFV plus ABC or to seek the best available therapy outside of the study NOTE Patients who choose the open-label combination may take other prescribed nucleoside analogs provided outside the study AS PER AMENDMENT 121797 It is strongly recommended that patients who reach a confirmed endpoint and elect to receive open-label therapy consider adding additional approved and novel if possible antiretroviral agents to their open-label regimen AS PER AMENDMENT 11298 Patients who choose the open-label combination may receive other approved antiretrovirals obtained outside the study provided the ACTG 368 team approves the combination AS PER AMENDMENT 8798 Subjects will take study medications for a maximum of 96 weeks depending on their time of study enrollment AS PER AMENDMENT 31099 A 24-week extension which will end July 30 1999 has been added to the study The extension applies to subjects currently on blinded Step 1 treatment on open-labeled Step 2 or on study but off treatment Subjects are to be unblinded in their study treatment and followed for the remainder of the extension Subjects continue on their current study drug schedule Subjects on blinded IDV plus EFV who upon unblinding not failure decide to add prescription ABC to their regimen will be considered off study treatment and will be followed for the duration of the extension those already registered on Step 2 will continue their Step 2 therapy Any subject who does not wish to continue on the study extension will be unblinded to their original randomized regimen Subjects who experience virologic failure during the extension should seek best available treatment following current recommendations to use as many approved novel antiretroviral agents as possible The new drug regimen may incorporate any or all of the study drugs
Prior to randomization patients are stratified by CD4 cell count cellsmm3 less than or equal to 50 versus greater than 50 and by ACTG 320 participation enrolled versus not enrolled Patients with greater than 50 CD4 cellsmm3 are randomized to 1 of 4 treatment arms Arms I II III or IV and patients with less than or equal to 50 CD4 cellsmm3 are randomized to 1 of 2 treatment arms Arms I and II All patients will be followed for 48 weeks beyond the enrollment of the last patient The regimens for the treatment arms are as follows Arm I - indinavir IDV plus EFV plus ABC placebo bid Arm II - IDV higher dose plus EFV lower dose plus ABC Arm III - IDV plus EFV plus ABC placebo and Arm IV - IDV higher dose plus EFV lower dose plus ABC If 15 week data indicates this is a reasonable dosing regimen the sample size in Arms III and IV will be expanded to include additional patients with a CD4 count greater than 50 cellsmm3 and allow for equal enrollment across all 4 treatment arms Those patients who roll over from ACTG 320 will be assigned to receive open-label treatment on Arm II and evaluated independently of the 4 treatment arms listed above
AS PER AMENDMENT 82797 Patients with 2 consecutive HIV RNA measurements at least 500 copiesml at week 16 or anytime thereafter are given the option to receive open-label treatment with IDV plus EFV plus ABC or to seek the best available therapy outside of the study NOTE Patients who choose the open-label combination may take other prescribed nucleoside analogs provided outside the study AS PER AMENDMENT 121797 It is strongly recommended that patients who reach a confirmed endpoint and elect to receive open-label therapy consider adding additional approved and novel if possible antiretroviral agents to their open-label regimen AS PER AMENDMENT 11298 Patients who choose the open-label combination may receive other approved antiretrovirals obtained outside the study provided the ACTG 368 team approves the combination AS PER AMENDMENT 8798 Subjects will take study medications for a maximum of 96 weeks depending on their time of study enrollment AS PER AMENDMENT 31099 A 24-week extension which will end July 30 1999 has been added to the study The extension applies to subjects currently on blinded Step 1 treatment on open-labeled Step 2 or on study but off treatment Subjects are to be unblinded in their study treatment and followed for the remainder of the extension Subjects continue on their current study drug schedule Subjects on blinded IDV plus EFV who upon unblinding not failure decide to add prescription ABC to their regimen will be considered off study treatment and will be followed for the duration of the extension those already registered on Step 2 will continue their Step 2 therapy Any subject who does not wish to continue on the study extension will be unblinded to their original randomized regimen Subjects who experience virologic failure during the extension should seek best available treatment following current recommendations to use as many approved novel antiretroviral agents as possible The new drug regimen may incorporate any or all of the study drugs
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 |
|---|---|---|---|
| 11331 | REGISTRY | DAIDS ES Registry Number | None |