Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002376
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Effectiveness of HIV RNA Viral Load Testing in Determining Treatment Type in HIV-Infected Patients
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Controlled Clinical Study to Determine If the Addition of HIV RNA Viral Load Is an Effective Tool in Determining Treatment Regimens for HIV-Infected Patients
Status:
COMPLETED
Status Verified Date:
1999-06
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 in HIV-infected patients whose baseline CD4 count is 300 to 750 cellsmm3 whether an antiretroviral treatment regimen based upon clinical evaluation and CD4 counts plus HIV RNA viral load is more effective than a treatment regimen based upon clinical evaluation and CD4 counts without the use of HIV RNA viral load information To assess relative utility of viral load testing in determining therapeutic choice by the surrogate marker of CD4 cell counts after 48 weeks of therapy
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cellsmm3 those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cellsmm3 those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements
Detailed Description:
It is hypothesized that among HIV-infected patients whose baseline CD4 count is in the range of 300 to 750 cellsmm3 those patients who incorporate initial and periodic viral RNA measurements in their therapeutic decisions will have higher CD4 counts after 48 weeks than patients whose therapeutic decisions do not incorporate initial and periodic viral RNA measurements
Approximately 540 patients are stratified on the basis of baseline CD4 counts and are randomized to one of two treatment groups 1 viral RNA treatment group or 2 non viral RNA treatment group Treatment modification is based upon CD4 count viral RNA levels group 1 only and clinical evaluation Patients receive one of the three antiretroviral treatments
1 No antiretroviral therapy
2 Double reverse transcriptase inhibitor RTI therapy consisting of any two therapy combinations of didanosine ddI lamivudine 3TC stavudine d4T or zidovudine ZDV based upon the treating physicians judgment The preferred combinations are ZDV 3TC d4T 3TC or ddI d4T
3 Triple antiretroviral therapy consisting of double antiretroviral therapy plus indinavir
Treatment decisions are based upon a standardized algorithm as follows
CD4 count 500-750 viral RNA 10000
Group 1 No retroviral therapy Group 2 No retroviral therapy
CD4 count 500-750 viral RNA 10000
Group 1 Triple therapy Group 2 No retroviral therapy
CD4 count 300-499 viral RNA 10000
Group 1 Double retroviral therapy Group 2 Double retroviral therapy
CD4 count 300-499 viral RNA 10000
Group 1 Triple therapy Group 2 Double retroviral therapy
CD4 count 200-299 viral RNA 10000
Group 1 Maintain same retroviral therapy unless there is a CD4 count decrease of 25-49 within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed there is a CD4 count decrease of 50 within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated or there is an AIDS-defining illness in which case triple therapy is initiated
Group 2 Same as Group 1
CD4 count 200-299 viral RNA 10000
Group 1 Triple therapy Group 2 Maintain same retroviral therapy unless there is a CD4 count decrease of 25-49 within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed there is a CD4 count decrease of 50 within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated or there is an AIDS-defining illness in which case triple therapy is initiated
CD4 count 200
Group 1 Triple therapy Group 2 Triple therapy
Approximately 540 patients are stratified on the basis of baseline CD4 counts and are randomized to one of two treatment groups 1 viral RNA treatment group or 2 non viral RNA treatment group Treatment modification is based upon CD4 count viral RNA levels group 1 only and clinical evaluation Patients receive one of the three antiretroviral treatments
1 No antiretroviral therapy
2 Double reverse transcriptase inhibitor RTI therapy consisting of any two therapy combinations of didanosine ddI lamivudine 3TC stavudine d4T or zidovudine ZDV based upon the treating physicians judgment The preferred combinations are ZDV 3TC d4T 3TC or ddI d4T
3 Triple antiretroviral therapy consisting of double antiretroviral therapy plus indinavir
Treatment decisions are based upon a standardized algorithm as follows
CD4 count 500-750 viral RNA 10000
Group 1 No retroviral therapy Group 2 No retroviral therapy
CD4 count 500-750 viral RNA 10000
Group 1 Triple therapy Group 2 No retroviral therapy
CD4 count 300-499 viral RNA 10000
Group 1 Double retroviral therapy Group 2 Double retroviral therapy
CD4 count 300-499 viral RNA 10000
Group 1 Triple therapy Group 2 Double retroviral therapy
CD4 count 200-299 viral RNA 10000
Group 1 Maintain same retroviral therapy unless there is a CD4 count decrease of 25-49 within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed there is a CD4 count decrease of 50 within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated or there is an AIDS-defining illness in which case triple therapy is initiated
Group 2 Same as Group 1
CD4 count 200-299 viral RNA 10000
Group 1 Triple therapy Group 2 Maintain same retroviral therapy unless there is a CD4 count decrease of 25-49 within 24 weeks of the count falling in the range of 300-499 in which case both retroviral therapies are changed there is a CD4 count decrease of 50 within the 48 weeks of therapy from the time the CD4 count fell within the range of 300-499 in which case triple therapy is initiated or there is an AIDS-defining illness in which case triple therapy is initiated
CD4 count 200
Group 1 Triple therapy Group 2 Triple therapy
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 |
|---|---|---|---|
| 056-00 | None | None | None |
| MK-0639 | None | None | None |