Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000912
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study on Amprenavir in Combination With Other Anti-HIV Drugs in HIV-Positive Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Trial of Amprenavir as Part of Dual Protease Inhibitor Regimens Placebo-Controlled in Combination With Abacavir Efavirenz and Adefovir Dipivoxil Versus Amprenavir Alone in HIV-Infected Subjects With Prior Exposure to Approved Protease Inhibitors and Loss of Virologic Suppression as Reflected by a Plasma HIV-1 RNA Concentration 1000 Copiesml
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:
The purpose of this study is to compare 4 different combinations of anti-HIV drugs and to determine the number of people whose HIV blood levels decrease to 200 copiesml or less while on the treatment This study evaluates the safety of these drug combinations which include an experimental protease inhibitor PI amprenavir
Despite the success that many patients have had with PI treatment regimens there is still a possibility that patients receiving PIs may continue to have high HIV blood levels Because of this possibility alternative drug combinations containing PIs are being studied It appears that amprenavir when taken with 3 or 4 other anti-HIV drugs may be effective in patients with prior PI treatment experience
Despite the success that many patients have had with PI treatment regimens there is still a possibility that patients receiving PIs may continue to have high HIV blood levels Because of this possibility alternative drug combinations containing PIs are being studied It appears that amprenavir when taken with 3 or 4 other anti-HIV drugs may be effective in patients with prior PI treatment experience
Detailed Description:
A number of studies both within and outside the ACTG have been initiated or are in development to try to address the issue of alternative treatments for patients who either do not achieve or lose virologic control while receiving protease inhibitors PIs Amprenavir APV is an attractive candidate to investigate as part of salvage regimens because 1 it has substantial antiretroviral activity 2 there are preliminary in vitro and in vivo data that suggest that resistance to this agent may be mediated in part by a unique mutation I50V and 3 its cross-resistance profile to the approved PIs is uncertain
Patients are selectively randomized to 1 of 4 study arms based on prior PI experience Those randomized to Arms A B or C receive 2 PIs 1 of which is amprenavir APV and those randomized to Arm D receive a single PI APV as part of their treatment regimen as follows
Arm A APV plus saquinavir soft gel capsule SQVsgc plus abacavir ABC plus efavirenz EFV plus adefovir ADV
Arm B APV plus indinavir IDV plus ABC plus EFV plus ADV Arm C APV plus nelfinavir NFV plus ABC plus EFV plus ADV Arm D APV plus placebo NFV IDV or SQVsgc plus ABC plus EFV plus ADV All patients receive L-carnitine supplementation All patients receive clinical physical assessments and laboratory testing during study as follows Weeks 2 4 and every 4 weeks thereafter A primary analysis is performed after the last patient has reached 24 weeks AS PER AMENDMENT 3200 At that time all patients are unblinded to their original treatment assignment Patients who experience virologic failure are unblinded and may choose 1 of the following 3 options Continue study medications open-label permanently discontinue study medications or selectively continue study medications AS PER AMENDMENT 3200 from the arm the patient was originally randomized to and combine with other approved antiretroviral agents AS PER AMENDMENT 3200 For patients adding didanosine ddI to their regimens monitoring for the development of pancreatitis is crucial Final evaluations are required for those patients who are off drug during the immediate 8-week period following the last dose of study treatment Beyond 8 weeks they are followed for incidence of death cancer congenital anomalies and permanent disabilities AS PER AMENDMENT 3200 Gilead Sciences has terminated its US development of ADV for HIV infection Gilead will continue to supply ADV for patients in ACTG 398 until the study closes Patients who are receiving ADV at the completion of the study may continue to access ADV through the Expanded Access Program provided that the physician and patient have determined that continued use of ADV is beneficial
Patients are selectively randomized to 1 of 4 study arms based on prior PI experience Those randomized to Arms A B or C receive 2 PIs 1 of which is amprenavir APV and those randomized to Arm D receive a single PI APV as part of their treatment regimen as follows
Arm A APV plus saquinavir soft gel capsule SQVsgc plus abacavir ABC plus efavirenz EFV plus adefovir ADV
Arm B APV plus indinavir IDV plus ABC plus EFV plus ADV Arm C APV plus nelfinavir NFV plus ABC plus EFV plus ADV Arm D APV plus placebo NFV IDV or SQVsgc plus ABC plus EFV plus ADV All patients receive L-carnitine supplementation All patients receive clinical physical assessments and laboratory testing during study as follows Weeks 2 4 and every 4 weeks thereafter A primary analysis is performed after the last patient has reached 24 weeks AS PER AMENDMENT 3200 At that time all patients are unblinded to their original treatment assignment Patients who experience virologic failure are unblinded and may choose 1 of the following 3 options Continue study medications open-label permanently discontinue study medications or selectively continue study medications AS PER AMENDMENT 3200 from the arm the patient was originally randomized to and combine with other approved antiretroviral agents AS PER AMENDMENT 3200 For patients adding didanosine ddI to their regimens monitoring for the development of pancreatitis is crucial Final evaluations are required for those patients who are off drug during the immediate 8-week period following the last dose of study treatment Beyond 8 weeks they are followed for incidence of death cancer congenital anomalies and permanent disabilities AS PER AMENDMENT 3200 Gilead Sciences has terminated its US development of ADV for HIV infection Gilead will continue to supply ADV for patients in ACTG 398 until the study closes Patients who are receiving ADV at the completion of the study may continue to access ADV through the Expanded Access Program provided that the physician and patient have determined that continued use of ADV is beneficial
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 |
|---|---|---|---|
| Substudy ACTG 5003s | Registry Identifier | DAIDS ES | None |
| 11354 | REGISTRY | None | None |