Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000840
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multicenter Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Exploratory Study to Evaluate the Effects of Antiretroviral Cessation on Plasma Associated HIV-1 RNA
Status:
COMPLETED
Status Verified Date:
2000-04
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:
To evaluate viral load in the blood stream of HIV-infected patients during a 28-day washout following cessation of long-term zidovudine AZT therapy
Because viral load amount of HIV RNA in the plasma is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials a washout period or cessation of current antiretroviral regimens is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug However the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied and the proper duration of washout is an estimate
Because viral load amount of HIV RNA in the plasma is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials a washout period or cessation of current antiretroviral regimens is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug However the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied and the proper duration of washout is an estimate
Detailed Description:
Because viral load amount of HIV RNA in the plasma is often used as a measure of the effectiveness of new antiretroviral drugs in clinical trials a washout period or cessation of current antiretroviral regimens is commonly required for study entry to allow for a drug-free steady state of viral load prior to initiation of the new drug However the kinetics of the viral rebound following drug withdrawal has not been sufficiently studied and the proper duration of washout is an estimate
Patients who have volunteered to temporarily cease antiretroviral therapy will be followed during a 28-day washout period Blood samples are drawn at each of nine clinic visits Patients may resume antiretrovirals after the 28-day washout
Patients who have volunteered to temporarily cease antiretroviral therapy will be followed during a 28-day washout period Blood samples are drawn at each of nine clinic visits Patients may resume antiretrovirals after the 28-day washout
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?: