Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000874
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
1999-11-02
Brief Title:
A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing GART Compared With Antiretroviral Management Without Plasma GART
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of the Short-Term Effects of Antiretroviral Management Based on Plasma Genotypic Antiretroviral Resistance Testing GART Compared With Antiretroviral Management Without Plasma GART
Status:
COMPLETED
Status Verified Date:
2013-09
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 determine the short-term virologic and immunologic effects of using plasma genotypic antiretroviral resistance testing GART results interpreted by study virologists AS PER AMENDMENT 91797 in the management of therapy for antiretroviral-experienced patients failing on one of the following regimens
1 zidovudine ZDV lamivudine 3TC indinavir IDV
2 ZDV 3TC saquinavir SQV
3 ZDV 3TC ritonavir RTV
4 stavudine d4T 3TC IDV AS PER AMENDMENT 112697 To determine the short-term effects of using plasma GART in the management of antiretroviral-experienced patients failing on a triple drug regimen that includes a single protease inhibitor indinavir IDV saquinavir SQV ritonavir RTV or nelfinavir NFV and two licensed nucleoside reverse transcriptase inhibitors NRTIs A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death All commercially available antiretrovirals and many of those in development have been associated with resistance Fortunately techniques are available to define HIV genotypic resistance in real time as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting Using genotypic antiretroviral resistance testing GART results along with other currently available markers may lead to improved treatment decisions compared with using currently available markers alone
1 zidovudine ZDV lamivudine 3TC indinavir IDV
2 ZDV 3TC saquinavir SQV
3 ZDV 3TC ritonavir RTV
4 stavudine d4T 3TC IDV AS PER AMENDMENT 112697 To determine the short-term effects of using plasma GART in the management of antiretroviral-experienced patients failing on a triple drug regimen that includes a single protease inhibitor indinavir IDV saquinavir SQV ritonavir RTV or nelfinavir NFV and two licensed nucleoside reverse transcriptase inhibitors NRTIs A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death All commercially available antiretrovirals and many of those in development have been associated with resistance Fortunately techniques are available to define HIV genotypic resistance in real time as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting Using genotypic antiretroviral resistance testing GART results along with other currently available markers may lead to improved treatment decisions compared with using currently available markers alone
Detailed Description:
A growing body of evidence suggests that antiretroviral resistance is associated with an increased risk of disease progression and death All commercially available antiretrovirals and many of those in development have been associated with resistance Fortunately techniques are available to define HIV genotypic resistance in real time as compared to techniques that measure phenotypic resistance that is not practical in a clinical setting Using genotypic antiretroviral resistance testing GART results along with other currently available markers may lead to improved treatment decisions compared with using currently available markers alone
128 patients are randomized to GART or no GART within each of four strata defined by current antiretroviral regimen
1 ZDV plus 3TC plus IDV
2 ZDV plus 3TC plus SQV
3 ZDV plus 3TC plus RTV
4 d4T plus 3TC plus IDV Each of the four strata contains 22 patients with CD4 counts of 50 - 199mm3 and 11 patients with CD4 counts of 200 - 500mm3 Upon randomization clinicians determine a treatment strategy with supplied baseline GART results GART arm or without them no-GART arm All patients remain on the triple antiretroviral regimen initiated at the randomization visit until at least the 8-week visit At this time changes in treatment will be allowed based on an inadequate response to therapy
AS PER AMENDMENT 91797 128 patients are randomized to therapy based on GART results or therapy not based on these results Patients are stratified into 8 groups defined by current antiretroviral regimen ZDV3TCIDV vs ZDV3TCSQV vs ZDV3TCRTV vs d4T3TCIDV and screening CD4 count 50-199 vs 200-500 Management of patients assigned to the GART group is based on recommendations of study virologists after independent review of patient plasma GART results in addition to current clinical practice Up to four different treatment regimens using only licensed drugs may be recommended ranked but considered approximately therapeutically equivalent The management of patients assigned to the no-GART group is based on current clinical practice and includes only licensed antiretrovirals AS PER AMENDMENT 112697 160 patients are randomized to GART or no GART within each of 8 strata defined by current antiretroviral regimen NRTI-1 plus NRTI-2 plus IDV vs NRTI-1 plus NRTI-2 plus SQV vs NRTI-1 plus NRTI-2 plus RTV vs NRTI-1 plus NRTI-2 plus NFV and screening CD4 cell count
128 patients are randomized to GART or no GART within each of four strata defined by current antiretroviral regimen
1 ZDV plus 3TC plus IDV
2 ZDV plus 3TC plus SQV
3 ZDV plus 3TC plus RTV
4 d4T plus 3TC plus IDV Each of the four strata contains 22 patients with CD4 counts of 50 - 199mm3 and 11 patients with CD4 counts of 200 - 500mm3 Upon randomization clinicians determine a treatment strategy with supplied baseline GART results GART arm or without them no-GART arm All patients remain on the triple antiretroviral regimen initiated at the randomization visit until at least the 8-week visit At this time changes in treatment will be allowed based on an inadequate response to therapy
AS PER AMENDMENT 91797 128 patients are randomized to therapy based on GART results or therapy not based on these results Patients are stratified into 8 groups defined by current antiretroviral regimen ZDV3TCIDV vs ZDV3TCSQV vs ZDV3TCRTV vs d4T3TCIDV and screening CD4 count 50-199 vs 200-500 Management of patients assigned to the GART group is based on recommendations of study virologists after independent review of patient plasma GART results in addition to current clinical practice Up to four different treatment regimens using only licensed drugs may be recommended ranked but considered approximately therapeutically equivalent The management of patients assigned to the no-GART group is based on current clinical practice and includes only licensed antiretrovirals AS PER AMENDMENT 112697 160 patients are randomized to GART or no GART within each of 8 strata defined by current antiretroviral regimen NRTI-1 plus NRTI-2 plus IDV vs NRTI-1 plus NRTI-2 plus SQV vs NRTI-1 plus NRTI-2 plus RTV vs NRTI-1 plus NRTI-2 plus NFV and screening CD4 cell count
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11598 | REGISTRY | DAIDS ES | None |