Ignite Creation Date:
2024-05-05 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000914
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of the Effectiveness of Different Anti-HIV Treatments in HIV-Positive Individuals Who Have Been on a Protease Inhibitor-Containing Drug Regimen for at Least 16 Weeks
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Study of the Virologic Efficacy of Different Antiretroviral AR Treatment Strategies in HIV-Infected Individuals With Detectable Plasma HIV RNA Measurements After at Least 16 Weeks on Their Initial Protease Inhibitor-Containing AR Regimens
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 compare different treatments for HIV infection to see which works best to lower HIV levels and to raise the number of CD4 cells cells of the immune system that fight infection in HIV-positive individuals who have been on a protease inhibitor-containing drug regimen for at least 16 weeks
Researchers have found that combination anti-HIV therapy multiple drugs given together can help prevent AIDS-related illnesses and help people with AIDS live longer In this study the anti-HIV drug efavirenz EFV will be tested with 1 or 2 other protease inhibitors PIs to see which combination works best to treat HIV infection EFV has been shown to limit the amount of HIV virus produced by infected cells
Researchers have found that combination anti-HIV therapy multiple drugs given together can help prevent AIDS-related illnesses and help people with AIDS live longer In this study the anti-HIV drug efavirenz EFV will be tested with 1 or 2 other protease inhibitors PIs to see which combination works best to treat HIV infection EFV has been shown to limit the amount of HIV virus produced by infected cells
Detailed Description:
Current recommendations for the initial treatment of HIV infection have centered on the reduction of plasma HIV levels It has been shown that a combination of 2 nucleoside reverse transcriptase inhibitors NRTIs and a PI is the most effective barriers to disease progression This study attempts to demonstrate these data
Two options are available for patients whose initial PI-containing regimen has failed to suppress viral replication
Option 1 consists of immediate versus deferred use of a nonnucleoside reverse transcriptase inhibitor NNRTI Patients who choose Option 1 are randomized to 1 of 2 groups
1 Ritonavir RTV plus soft gelatin capsule saquinavir SQV-SGC plus efavirenz EFV
2 RTV plus SQV-SGC
Option 2 consists of treatment with a single PI versus double PI Patients who choose Option 2 are randomized to 1 of 2 groups
1 Nelfinavir NFV plus EFV
2 RTV plus SQV-SGC plus EFV
Patients failing NFV in Option 2 are randomized to one of two groups
1 Indinavir IDV plus EFV
2 RTV plus SQV-SGC plus EFV Patients remain on study treatment regimens for 8 weeks Follow-up visits including history and physical evaluations take place at specified intervals during the next 12 months
Two options are available for patients whose initial PI-containing regimen has failed to suppress viral replication
Option 1 consists of immediate versus deferred use of a nonnucleoside reverse transcriptase inhibitor NNRTI Patients who choose Option 1 are randomized to 1 of 2 groups
1 Ritonavir RTV plus soft gelatin capsule saquinavir SQV-SGC plus efavirenz EFV
2 RTV plus SQV-SGC
Option 2 consists of treatment with a single PI versus double PI Patients who choose Option 2 are randomized to 1 of 2 groups
1 Nelfinavir NFV plus EFV
2 RTV plus SQV-SGC plus EFV
Patients failing NFV in Option 2 are randomized to one of two groups
1 Indinavir IDV plus EFV
2 RTV plus SQV-SGC plus EFV Patients remain on study treatment regimens for 8 weeks Follow-up visits including history and physical evaluations take place at specified intervals during the next 12 months
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 |
|---|---|---|---|
| 11610 | REGISTRY | DAIDS ES | None |