Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000939
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Compare the Effectiveness of Different Anti-HIV Drug Regimens in Keeping Levels of HIV in the Blood as Low as Possible
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Randomized Open-Label Study of Maintenance of HIV RNA Suppression After Switching to ddId4THU vs ddId4TEFV vs Continuing the Pre-Entry Protease Inhibitor Regimen
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 look at different anti-HIV drug regimens to see which works best to keep the level of HIV viral load in the blood as low as possible during maintenance therapy You will be assigned randomly like tossing a coin to 1 of 3 groups
Group 1 Didanosine plus stavudine plus hydroxyurea ddId4THU Group 2 Didanosine plus stavudine plus efavirenz ddId4TEFV Group 3 This group of patients will remain on their current drug regimens This study will last approximately 3 years you will receive study medications for the duration of the study
Anti-HIV drug regimens that include protease inhibitors PIs are very good at lowering viral load However some patients have a rise in HIV levels while on PI maintenance It may be possible to keep HIV levels low using another class of drugs for maintenance that are easier to take and less expensive than PIs If viral load increases while a patient is taking this second group of drugs it may be possible to restart the PI drug regimen and again decrease HIV levels
Group 1 Didanosine plus stavudine plus hydroxyurea ddId4THU Group 2 Didanosine plus stavudine plus efavirenz ddId4TEFV Group 3 This group of patients will remain on their current drug regimens This study will last approximately 3 years you will receive study medications for the duration of the study
Anti-HIV drug regimens that include protease inhibitors PIs are very good at lowering viral load However some patients have a rise in HIV levels while on PI maintenance It may be possible to keep HIV levels low using another class of drugs for maintenance that are easier to take and less expensive than PIs If viral load increases while a patient is taking this second group of drugs it may be possible to restart the PI drug regimen and again decrease HIV levels
Detailed Description:
Combination antiretroviral therapies using protease inhibitors PIs are capable of suppressing plasma HIV RNA to undetectable levels However approximately 10 of patients who achieve undetectable viral loads will experience a detectable rise in HIV RNA each year When HIV replication has been suppressed to very low levels it may be possible to consolidate antiretroviral therapy into a simpler and potentially less toxic maintenance regimen without a PI Such a regimen would ideally be potent enough to continue to maintain viral suppression but use agents that are better tolerated more easily salvaged less expensive andor more convenient than PI-containing regimens Subsequent rises in HIV viremia with non-PI maintenance regimens may respond to resumption of the pre-maintenance PI-containing regimen extending the use of the potent PI class
Patients are randomized 111 to treatment with ddId4THU Arm A versus ddId4TEFV Arm B versus continuation of the pre-entry PI-containing regimen Arm C Viral load is measured at Weeks 1 2 4 8 12 16 20 and 24 then every 8 weeks for up to 3 years Upon virologic failure plasma HIV RNA greater than or equal to 200 copiesml or drug intolerance patients on the maintenance regimens Arms A and B restart their pre-entry PI-containing regimen Patients on Arm C are managed according to best medical judgment of their primary care provider in the event of virologic failure
Patients are randomized 111 to treatment with ddId4THU Arm A versus ddId4TEFV Arm B versus continuation of the pre-entry PI-containing regimen Arm C Viral load is measured at Weeks 1 2 4 8 12 16 20 and 24 then every 8 weeks for up to 3 years Upon virologic failure plasma HIV RNA greater than or equal to 200 copiesml or drug intolerance patients on the maintenance regimens Arms A and B restart their pre-entry PI-containing regimen Patients on Arm C are managed according to best medical judgment of their primary care provider in the event of virologic failure
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 |
|---|---|---|---|
| ACTG A5039 | Registry Identifier | DAIDS ES | None |
| 10885 | REGISTRY | None | None |