Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001069
Status:
TERMINATED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of Two Methods of Determining When to Begin or Change Anti-HIV Treatment
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 Clinical Effects of Initiating or Changing Antiretroviral Therapy Based on Plasma HIV RNA Quantitation Compared With Initiating or Changing Therapy Based on Current Clinical Practice Alone
Status:
TERMINATED
Status Verified Date:
2003-01
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:
PRIMARY To compare the clinical efficacy of two decision making strategies for initiating or changing antiretroviral therapy decision making based on current clinical practice alone ie initiating or changing therapy based on CD4 count decline andor clinical progression versus decision making based on plasma HIV RNA quantitation in addition to current clinical practice
SECONDARY To evaluate toxicity biological markers and patient management in the two arms
Although changing therapies is a common strategy in the treatment of HIV disease guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy However uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms
SECONDARY To evaluate toxicity biological markers and patient management in the two arms
Although changing therapies is a common strategy in the treatment of HIV disease guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy However uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms
Detailed Description:
Although changing therapies is a common strategy in the treatment of HIV disease guidelines are needed to help clinicians and patients decide when a change in antiretroviral therapy is indicated The technology of measuring HIV RNA in plasma has been suggested as a tool for monitoring clinical drug efficacy However uncertainty remains about whether aggressive antiretroviral treatment to lower HIV RNA and maintain low levels for as long as possible will confer clinical benefit in comparison with management based on monitoring CD4 counts and HIV-related symptoms
Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with 300 CD4 cellsmm3 All patients in the RNA arm as well as a subset n 183 of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months The results of these quantitations will be blinded until the end of the study CD4 counts will be obtained at least every 4 months if the previous count was 20 cellsmm3 The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians current clinical practices Medications clinical status and changes in antiretroviral therapy will be recorded for all patients in the study Patients are stratified by CD4 cell count 100 cellsmm3 200 patients vs 100-300 cellsmm3 900 patients
Patients are randomized to a decision making strategy for initiating or changing therapy based on current clinical practice alone vs decision making based on plasma HIV RNA quantitation in addition to current clinical practice in patients with 300 CD4 cellsmm3 All patients in the RNA arm as well as a subset n 183 of those in the CCP arm will have a plasma HIV RNA quantitation drawn every 4 months The results of these quantitations will be blinded until the end of the study CD4 counts will be obtained at least every 4 months if the previous count was 20 cellsmm3 The remaining patients in the CCP arm will have CD4 counts obtained according to their clinicians current clinical practices Medications clinical status and changes in antiretroviral therapy will be recorded for all patients in the study Patients are stratified by CD4 cell count 100 cellsmm3 200 patients vs 100-300 cellsmm3 900 patients
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?: