Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004855
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-02-29
Brief Title:
Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open-Label Pilot Treatment Trial Evaluating Cellular Dynamics and Immune Restoration in Treatment-Naive HIV-Infected Subjects Receiving Either the Protease Inhibitor LPVr or the Nucleoside Analogue Reverse Transcriptase Inhibitors d4T3TCAbacavir With the Non-Nucleoside Reverse Transcriptase Inhibitor Nevirapine
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:
This study will compare an anti-HIV drug combination of protease inhibitor plus a nonnucleoside reverse transcriptase inhibitor NNRTI to one that includes three nucleoside reverse transcriptase inhibitors NRTIs plus an NNRTI NNRTIs NRTIs and protease inhibitors are all types of anti-HIV drugs that block the virus in some way
This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI CD4 cells are cells of the immune system that fight infection This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients
This study will try to find out if a treatment regimen containing a protease inhibitor plus an NNRTI has a different effect on the rise of CD4 cells compared to a treatment made up of three NRTIs plus an NNRTI CD4 cells are cells of the immune system that fight infection This study will also try to see if the combination of drugs used in this study is safe to use in HIV-positive patients
Detailed Description:
This study is designed to further define the dynamics and the mechanisms of the CD4 cell rise seen following administration of potent antiretroviral therapy It will ascertain if treatment regimens containing nucleoside reverse transcriptase inhibitors NRTIs with a nonnucleoside reverse transcriptase inhibitor NNRTI have different effects on CD4 dynamics than regimens composed of a protease inhibitor with an NNRTI
Patients are randomized to one of the two treatment arms listed below They are stratified based on CD4 count and whether they choose to participate in substudy A5036s
Arm A protease inhibitor plus NNRTI regimen At Day 0 entry patients begin taking LPVRTV At Day 3 patients add NVP once daily for 2 weeks and then twice daily for the remainder of the study
Arm B triple reverse transcriptase inhibitors plus NNRTI regimen At Day 0 entry patients begin taking 3TC plus d4T plus ABC At Day 3 patients add NVP once daily for 2 weeks and then twice daily for the remainder of the study
HIV RNA analysis is performed at Weeks 4 and 5 If the mean is at least 10 log10 lower than the baseline HIV RNA the patient may continue on study treatment If the mean is not at least 10 log10 lower however patients are discontinued from the study by no later than Week 8 After 8 weeks of treatment patients may change antiretroviral medications with permission of the protocol chair or vice chairs Regular clinical evaluations are conducted Blood is drawn to determine HIV RNA quantification absolute CD4 and CD8 counts immunological evaluations telomere assays and part is stored for future testing Skin testing and return visits for delayed-type hypersensitivity to standard recall antigens are done on three occasions Patients remain on the study for 48 weeks Substudy A5036s evaluates viral dynamics during study treatment Serial plasma samples are collected during the first 24 hours of treatment and at Day 3 and Week 4 Plasma HIV measurements are performed to differentiate between infectious and non-infectious particle production
Patients are randomized to one of the two treatment arms listed below They are stratified based on CD4 count and whether they choose to participate in substudy A5036s
Arm A protease inhibitor plus NNRTI regimen At Day 0 entry patients begin taking LPVRTV At Day 3 patients add NVP once daily for 2 weeks and then twice daily for the remainder of the study
Arm B triple reverse transcriptase inhibitors plus NNRTI regimen At Day 0 entry patients begin taking 3TC plus d4T plus ABC At Day 3 patients add NVP once daily for 2 weeks and then twice daily for the remainder of the study
HIV RNA analysis is performed at Weeks 4 and 5 If the mean is at least 10 log10 lower than the baseline HIV RNA the patient may continue on study treatment If the mean is not at least 10 log10 lower however patients are discontinued from the study by no later than Week 8 After 8 weeks of treatment patients may change antiretroviral medications with permission of the protocol chair or vice chairs Regular clinical evaluations are conducted Blood is drawn to determine HIV RNA quantification absolute CD4 and CD8 counts immunological evaluations telomere assays and part is stored for future testing Skin testing and return visits for delayed-type hypersensitivity to standard recall antigens are done on three occasions Patients remain on the study for 48 weeks Substudy A5036s evaluates viral dynamics during study treatment Serial plasma samples are collected during the first 24 hours of treatment and at Day 3 and Week 4 Plasma HIV measurements are performed to differentiate between infectious and non-infectious particle production
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 |
|---|---|---|---|
| Substudy ACTG AA5036s | Registry Identifier | DAIDS ES | None |
| 10866 | REGISTRY | None | None |
| ACTG A5014 | None | None | None |
| AACTG A5014 | None | None | None |