Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000861
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Brief Title:
The Addition of Indinavir to Anti-HIV Treatment 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 Trial of Immediate Versus Deferred Indinavir in Addition to Background Antiretroviral Therapy in HIV-Infected Patients With CD4 Cell Counts Between 200 and 500mm3 and Plasma HIV RNA Levels 10000 Copiesml
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 evaluate the effect of immediate versus deferred indinavir IDV in addition to background therapy on disease progression or death in patients with CD4 cell counts between 200 and 500 cellsmm3 and plasma HIV RNA levels 10000 copiesml
This study aims to examine two management strategies immediate versus deferred IDV therapy for their clinical effects in the context of background antiretroviral AR therapy given according to current clinical practice There is an urgent need to identify the optimal use of IDV in patient management since clinical endpoint studies have not been completed in the United States Since there is little information about the long term durability of clinical effects and even less information about the timing of the initiation of protease inhibitor therapy exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients
This study aims to examine two management strategies immediate versus deferred IDV therapy for their clinical effects in the context of background antiretroviral AR therapy given according to current clinical practice There is an urgent need to identify the optimal use of IDV in patient management since clinical endpoint studies have not been completed in the United States Since there is little information about the long term durability of clinical effects and even less information about the timing of the initiation of protease inhibitor therapy exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients
Detailed Description:
This study aims to examine two management strategies immediate versus deferred IDV therapy for their clinical effects in the context of background antiretroviral AR therapy given according to current clinical practice There is an urgent need to identify the optimal use of IDV in patient management since clinical endpoint studies have not been completed in the United States Since there is little information about the long term durability of clinical effects and even less information about the timing of the initiation of protease inhibitor therapy exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients
Prior to randomization the patient and clinician will determine whether the background therapy will be zidovudine ZDV plus lamivudine 3TC or other background antiretroviral therapy OBAT Patients will then be randomized to IDV or matching placebo AS PER AMENDMENT 062797 The protocol was closed as of 032597 and all patients have been unblinded to their assigned treatment Patients still on study medication are eligible for the protocol extension Patients who were randomized to immediate IDV may continue on therapy for up to an additional 4 months All study therapy both for those on immediate or delayed therapy must be discontinued on 102497
Prior to randomization the patient and clinician will determine whether the background therapy will be zidovudine ZDV plus lamivudine 3TC or other background antiretroviral therapy OBAT Patients will then be randomized to IDV or matching placebo AS PER AMENDMENT 062797 The protocol was closed as of 032597 and all patients have been unblinded to their assigned treatment Patients still on study medication are eligible for the protocol extension Patients who were randomized to immediate IDV may continue on therapy for up to an additional 4 months All study therapy both for those on immediate or delayed therapy must be discontinued on 102497
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 |
|---|---|---|---|
| 11591 | REGISTRY | DAIDS ES Registry Number | None |