Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001084
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir 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 Prospective Randomized Double-Blind Trial of Three Maintenance Regimens for HIV-Infected Subjects Receiving Induction Therapy With Zidovudine Lamivudine and Indinavir
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 proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels AS PER AMENDMENT 091997 below 200 copiesmL by Roche UltraSensitive assay among the 3 regimens during the maintenance phase
The objective of antiretroviral therapy is to reduce HIV replication preserve immunologic function and delay the development of HIV-related complications In patients administered potent antiretroviral regimens HIV RNA levels are reduced below 500 copiesml of plasma and below the level of detection of commercially available assays This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens
The objective of antiretroviral therapy is to reduce HIV replication preserve immunologic function and delay the development of HIV-related complications In patients administered potent antiretroviral regimens HIV RNA levels are reduced below 500 copiesml of plasma and below the level of detection of commercially available assays This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens
Detailed Description:
The objective of antiretroviral therapy is to reduce HIV replication preserve immunologic function and delay the development of HIV-related complications In patients administered potent antiretroviral regimens HIV RNA levels are reduced below 500 copiesml of plasma and below the level of detection of commercially available assays This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens
All patients will receive open label induction therapy with zidovudine ZDV lamivudine 3TC and indinavir IDV for 6 months Following the 6 month induction phase patients with undetectable plasma HIV RNA at weeks 16 20 and 24 will enter the maintenance phase blinded maintenance phase AS PER AMENDMENT 091997 and be randomized to one of three maintenance regimens ie either continued ZDV3TCIDV control or ZDV3TCIDV placebo or ZDV placebo3TC placeboIDV Prior to randomization patients are stratified according to entry HIV RNA level greater than or equal to 30000 or less than 30000 copiesml and by prior ZDV therapy at least 7 days or less than 7 days After 12 months AS PER AMENDMENT 091997 18 months of maintenance therapy treatment will be withdrawn at 6-month intervals in randomly-selected patients who have achieved undetectable HIV RNA AS PER 091997 AMENDMENT After 18 months of blinded maintenance therapy treatment is unblinded for patients whose HIV RNA levels remain detectable Such patients receive optimal therapy either continuing the protocol regimen or initiating alternative therapy
AS PER AMENDMENT 22798 An interim review conducted in January 1998 demonstrated that the strategy of less intensive antiviral therapy after 6 months of IDV3TCZDV induction therapy is less effective than continuation of triple drug therapy except for ZDV-naive patients assigned to ZDV3TC Therefore the maintenance phase of this study has been discontinued
Patients currently on blinded maintenance are unblinded immediately and have the option of reinitiating open-label triple therapy with IDV3TCZDV or discontinuing study treatment Patients currently on induction may register for continued open-label triple therapy or may discontinue study treatment This amendment allows treatment extension so that subjects may receive open-label triple therapy until May 31 1998 At that time a rollover protocol or another modification with a longer period of drug supply may become available Patients who choose to go off treatment are followed until May 31 1998
AS PER AMENDMENT 042398 This study will now provide treatment with open-label ZDV3TCIDV until August 1 1998 A rollover protocol or another 343 protocol modification with a longer period of drug supply may become available but this cannot be guaranteed
AS PER AMENDMENT 061998 This study will now provide treatment with open-label ZDV3TCIDV until either November 1 1998 or until 3 months after the rollover study A5025 is available to the study sites whichever comes first
All patients will receive open label induction therapy with zidovudine ZDV lamivudine 3TC and indinavir IDV for 6 months Following the 6 month induction phase patients with undetectable plasma HIV RNA at weeks 16 20 and 24 will enter the maintenance phase blinded maintenance phase AS PER AMENDMENT 091997 and be randomized to one of three maintenance regimens ie either continued ZDV3TCIDV control or ZDV3TCIDV placebo or ZDV placebo3TC placeboIDV Prior to randomization patients are stratified according to entry HIV RNA level greater than or equal to 30000 or less than 30000 copiesml and by prior ZDV therapy at least 7 days or less than 7 days After 12 months AS PER AMENDMENT 091997 18 months of maintenance therapy treatment will be withdrawn at 6-month intervals in randomly-selected patients who have achieved undetectable HIV RNA AS PER 091997 AMENDMENT After 18 months of blinded maintenance therapy treatment is unblinded for patients whose HIV RNA levels remain detectable Such patients receive optimal therapy either continuing the protocol regimen or initiating alternative therapy
AS PER AMENDMENT 22798 An interim review conducted in January 1998 demonstrated that the strategy of less intensive antiviral therapy after 6 months of IDV3TCZDV induction therapy is less effective than continuation of triple drug therapy except for ZDV-naive patients assigned to ZDV3TC Therefore the maintenance phase of this study has been discontinued
Patients currently on blinded maintenance are unblinded immediately and have the option of reinitiating open-label triple therapy with IDV3TCZDV or discontinuing study treatment Patients currently on induction may register for continued open-label triple therapy or may discontinue study treatment This amendment allows treatment extension so that subjects may receive open-label triple therapy until May 31 1998 At that time a rollover protocol or another modification with a longer period of drug supply may become available Patients who choose to go off treatment are followed until May 31 1998
AS PER AMENDMENT 042398 This study will now provide treatment with open-label ZDV3TCIDV until August 1 1998 A rollover protocol or another 343 protocol modification with a longer period of drug supply may become available but this cannot be guaranteed
AS PER AMENDMENT 061998 This study will now provide treatment with open-label ZDV3TCIDV until either November 1 1998 or until 3 months after the rollover study A5025 is available to the study sites whichever comes first
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 |
|---|---|---|---|
| 11314 | REGISTRY | DAIDS ES Registry Number | None |