Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029341
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2002-01-10
Brief Title:
A Study to Demonstrate That Anti-HIV Drug Therapy Can be Stopped Without Causing Viral Resistance and to Characterize Drug Elimination From the Body
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Study to Demonstrate That Therapy With Efavirenz EFV and Other Antiretroviral Drugs Can Be Interrupted Without Selecting for EFV-Resistant Virus and Relation to Kinetics of Drug Elimination
Status:
COMPLETED
Status Verified Date:
2005-01
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 find out if anti-HIV drugs can be stopped without the virus becoming resistant to the drugs The study will also examine how fast anti-HIV drugs leave the body
Not all HIV-infected patients may require continuous and indefinite anti-HIV therapy There is evidence that stopping anti-HIV therapy will not make the virus resistant to efavirenz EFV an anti-HIV drug that remains in the body longer than most treatment drugs In another study patients were treated with EFV zidovudine ZDV and lamivudine 3TC The patients virus was controlled despite the fact that some patients missed medication dosages Many patients stop anti-HIV therapy because of negative effects This study will examine the bodys ability to fight and control virus in patients who stop therapy
Not all HIV-infected patients may require continuous and indefinite anti-HIV therapy There is evidence that stopping anti-HIV therapy will not make the virus resistant to efavirenz EFV an anti-HIV drug that remains in the body longer than most treatment drugs In another study patients were treated with EFV zidovudine ZDV and lamivudine 3TC The patients virus was controlled despite the fact that some patients missed medication dosages Many patients stop anti-HIV therapy because of negative effects This study will examine the bodys ability to fight and control virus in patients who stop therapy
Detailed Description:
The concept that all patients with HIV-1 infection require continuous and indefinite antiretroviral therapy ART has been questioned There are both theoretical reasons and supporting empiric evidence that suggest that discontinuing ART should not select for EFV-resistance In Dupont Protocol 006 antiretroviral-naive patients were randomized to receive EFV ZDV and 3TC This regimen was associated with an excellent and sustained virologic response It is certain that many patients in this study were able to maintain sustained suppression of HIV-1 RNA to below limits of detection despite missing occasional doses of all medications Since therapy with ZDV and 3TC alone is unlikely to maintain virologic control emergence of substantial high-level EFV resistance should have led to virologic failure The fact that there were relatively few virologic failures in that study provides indirect but strong evidence that simultaneous discontinuation of EFV ZDV and 3TC is unlikely to be associated with emergence of EFV resistance Many individuals discontinue antiretroviral therapy because of adverse effects This study provides the opportunity to determine whether the virologic response of patients who discontinue antiretroviral therapy will be compromised
Participants will discontinue their EFV Other antiretroviral drugs in the patients regimens may be continued for up to three days after the last EFV dose Patients will not resume EFV or other antiretroviral agents for at least 28 days after stopping EFV unless the CD4 cell count declines to a level that indicates the need to resume therapy Throughout the study patients will have blood drawn on specified days for plasma EFV assays intracellular NRTI-TP assays and demonstration of EFV resistance After patients have been off their antiretrovirals for at least four weeks they may choose to restart their ART start a new regimen or discontinue their ART Patients who restart their ART need to come to the clinic seven days after restarting to have blood drawn After plasma EFV assays have been completed and HIV resistance has not been demonstrated three patients will have a clonal analysis performed
Participants will discontinue their EFV Other antiretroviral drugs in the patients regimens may be continued for up to three days after the last EFV dose Patients will not resume EFV or other antiretroviral agents for at least 28 days after stopping EFV unless the CD4 cell count declines to a level that indicates the need to resume therapy Throughout the study patients will have blood drawn on specified days for plasma EFV assays intracellular NRTI-TP assays and demonstration of EFV resistance After patients have been off their antiretrovirals for at least four weeks they may choose to restart their ART start a new regimen or discontinue their ART Patients who restart their ART need to come to the clinic seven days after restarting to have blood drawn After plasma EFV assays have been completed and HIV resistance has not been demonstrated three patients will have a clonal analysis performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None