Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001087
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
The Effectiveness of Nelfinavir and Efavirenz Used Alone or Together Combined With Other Anti-HIV Drugs in Patients Who Have Taken Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Comparison of the Virologic Efficacy of Nelfinavir andor DMP 266 Efavirenz EFV in Combination With One or Two New Nucleoside Analogs in Nucleoside Experienced Subjects A Roll-Over Study to ACTG 302303
Status:
COMPLETED
Status Verified Date:
2021-10
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:
Steps I and II The purpose of this study is the following To look at how many patients achieve undetectable HIV blood levels at Week 16 To look at the absolute change in HIV blood levels from the beginning of the study to Week 16 To look at the safety and tolerability of nelfinavir NFV and efavirenz EFV when used in combination or separately in regimens containing reverse transcriptase inhibitors RTIs For the 2 extension studies Weeks 49 to 144 To look at the proportion of patients whose long-term viral load remains undetectable at Week 96 To look at the time from the beginning of the study to treatment failure with patients evaluated through Week 144 Step III To look at the proportion of patients whose HIV blood levels are undetectable 16 weeks after starting the salvage study treatment To assess safety toxicity and tolerance of salvage study drug treatment This study has been changed by adding new objectives Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy However there are few established guidelines for devising combinations of different classes of drugs which will enhance the potential for achieving viral suppression reducing the risk of toxicity and preserving therapeutic options for future use This study includes 2 anti-HIV drugs NFV a protease inhibitor PI and EFV a nonnucleoside reverse transcriptase inhibitor NNRTI for use either alone or in combination with RTI therapy for the purpose of limiting HIV replication Patients with treatment failure at Week 16 choose 1 of the following 3 alternative salvage therapies 2-drug PI regimen saquinavir and ritonavir plus adefovir dipivoxil and L-carnitine EFV or NFV if not already given plus 2 new approved anti-HIV drugs outside the study or the best available treatment outside the study The new RTI adefovir dipivoxil is added to the 2-drug PI regimen to achieve suppression of viral replication and thereby delay disease progression This rationale reflects a change in the treatment given to patients with treatment failure at Week 16
Detailed Description:
Achieving viral suppression has been widely endorsed as the primary goal of HIV therapy yet there are few established guidelines to provide the framework by which to devise combinations of different classes of drugs which will not only enhance the potential for achieving viral suppression while reducing the risk of toxicity but will also preserve therapeutic options for future use This study includes 2 antiretroviral compounds NFV a protease inhibitor PI and EFV a nonnucleoside reverse transcriptase inhibitor NNRTI for use either alone or in combination with reverse transcriptase inhibitor RTI therapy for the purpose of limiting HIV replication AS PER AMENDMENT 3598 Patients who experience treatment failure at Week 16 or later choose 1 of the following alternative potent salvage therapy regimens a dual-PI regimen saquinavirritonavir plus adefovir dipivoxil and L-carnitine EFV or NFV if not already given plus 2 new approved antiretroviral drugs outside the study or the best available treatment outside the study The new reverse transcriptase inhibitor adefovir dipivoxil is added to the dual-PI regimen to achieve suppression of viral replication and thereby delay disease progression
Step I Patients with detectable plasma HIV RNA levels are assigned to Group A and those with undetectable levels are assigned to Group B control
Group A Patients are randomized to 1 of 3 treatment arms NFV plus EFV placebo on Arm I NFV placebo plus EFV on Arm II or NFV plus EFV on Arm III Concurrent with their randomly assigned therapy patients receive open-label RTI therapy comprising 1 of the following 3 combinations that provides 1 or 2 new RTIs didanosine ddI plus stavudine d4T lamivudine 3TC plus d4T or ddI plus 3TC AS PER AMENDMENT 120297 Patients with virologic failure at Week 16 seek the best available therapy outside the study or continue study medication for up to 120 days AS PER AMENDMENT 3598 Patients with virologic failure at Week 16 now proceed to Step III Patients without virologic failure continue therapy during Weeks 1 to 48 AS PER AMENDMENT 3598 and those without virologic failure at Week 48 may continue therapy during Weeks 49 to 96 first extension study AS PER AMENDMENT 52799 After Week 96 patients in Arm I may switch to Arm III or seek the best available antiretroviral therapy outside the study Patients in Arm II or III with undetectable plasma HIV RNA levels at Week 96 may continue therapy during Weeks 97 to 144 second extension study or seek the best alternative antiretroviral therapy Patients in Arm II or III with detectable plasma HIV RNA levels but without virologic failure at Week 48 continue their current study therapy or proceed to Step III Patients with confirmed virologic failure at Week 48 or later proceed to Step III or seek the best available alternative therapy outside the study Group B Patients receive treatment on their assigned open-label ACTG 302303 regimen Patients with detectable plasma HIV RNA levels discontinue Group B therapy and proceed to Step II Patients with undetectable plasma HIV RNA levels continue therapy during Weeks 1 to 48 AS PER AMENDMENT 62498 and those with undetectable levels at Week 48 may continue therapy during Weeks 49 to 96 first extension study AS PER AMENDMENT 52799 Patients with undetectable levels at Week 96 may continue therapy during Weeks 97 to 144 second extension study Step II Patients receive treatment as in Group A Step III AS PER AMENDMENT 3598 Patients choose 1 of 3 alternative therapies saquinavir soft gel capsule ritonavir adefovir dipivoxil and L-carnitine on Arm X EFV or NFV plus 2 new approved antiretroviral drugs outside the study on Arm Y if no prior EFV or NFV or best available medication outside the study on Arm Z
Patients in Arm X or Y are followed on salvage therapy for 24 to 48 weeks Patients with detectable plasma HIV RNA levels after 16 weeks on salvage therapy are encouraged to discontinue study medication and seek best alternative treatment
Step I Patients with detectable plasma HIV RNA levels are assigned to Group A and those with undetectable levels are assigned to Group B control
Group A Patients are randomized to 1 of 3 treatment arms NFV plus EFV placebo on Arm I NFV placebo plus EFV on Arm II or NFV plus EFV on Arm III Concurrent with their randomly assigned therapy patients receive open-label RTI therapy comprising 1 of the following 3 combinations that provides 1 or 2 new RTIs didanosine ddI plus stavudine d4T lamivudine 3TC plus d4T or ddI plus 3TC AS PER AMENDMENT 120297 Patients with virologic failure at Week 16 seek the best available therapy outside the study or continue study medication for up to 120 days AS PER AMENDMENT 3598 Patients with virologic failure at Week 16 now proceed to Step III Patients without virologic failure continue therapy during Weeks 1 to 48 AS PER AMENDMENT 3598 and those without virologic failure at Week 48 may continue therapy during Weeks 49 to 96 first extension study AS PER AMENDMENT 52799 After Week 96 patients in Arm I may switch to Arm III or seek the best available antiretroviral therapy outside the study Patients in Arm II or III with undetectable plasma HIV RNA levels at Week 96 may continue therapy during Weeks 97 to 144 second extension study or seek the best alternative antiretroviral therapy Patients in Arm II or III with detectable plasma HIV RNA levels but without virologic failure at Week 48 continue their current study therapy or proceed to Step III Patients with confirmed virologic failure at Week 48 or later proceed to Step III or seek the best available alternative therapy outside the study Group B Patients receive treatment on their assigned open-label ACTG 302303 regimen Patients with detectable plasma HIV RNA levels discontinue Group B therapy and proceed to Step II Patients with undetectable plasma HIV RNA levels continue therapy during Weeks 1 to 48 AS PER AMENDMENT 62498 and those with undetectable levels at Week 48 may continue therapy during Weeks 49 to 96 first extension study AS PER AMENDMENT 52799 Patients with undetectable levels at Week 96 may continue therapy during Weeks 97 to 144 second extension study Step II Patients receive treatment as in Group A Step III AS PER AMENDMENT 3598 Patients choose 1 of 3 alternative therapies saquinavir soft gel capsule ritonavir adefovir dipivoxil and L-carnitine on Arm X EFV or NFV plus 2 new approved antiretroviral drugs outside the study on Arm Y if no prior EFV or NFV or best available medication outside the study on Arm Z
Patients in Arm X or Y are followed on salvage therapy for 24 to 48 weeks Patients with detectable plasma HIV RNA levels after 16 weeks on salvage therapy are encouraged to discontinue study medication and seek best alternative treatment
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 |
|---|---|---|---|
| 10691 | REGISTRY | DAIDS ES | None |