Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000918
Status:
COMPLETED
Last Update Posted:
2012-05-21
First Post:
1999-11-02
Brief Title:
A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir an Anti-HIV DrugTreatment Failure
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 Open-Label Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals With Virological Evidence of Nelfinavir Treatment Failure as Reflected by Plasma HIV RNA Concentration of 1000 Copiesml
Status:
COMPLETED
Status Verified Date:
2012-05
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 determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load level of HIV in the blood in HIV-positive patients who have failed nelfinavir NFV treatment
In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed it is best to test a variety different of drug cocktails drug regimens The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors NRTIs efavirenz an NNRTI non-nucleoside reverse transcriptase inhibitor and either 1 or 2 protease inhibitors It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail
In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed it is best to test a variety different of drug cocktails drug regimens The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors NRTIs efavirenz an NNRTI non-nucleoside reverse transcriptase inhibitor and either 1 or 2 protease inhibitors It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail
Detailed Description:
To maximize the likelihood of a favorable response to salvage therapy 4 or 5 drug regimens should be studied Regimens containing fewer drugs particularly those lacking a non-nucleoside reverse transcriptase inhibitor NNRTI such as efavirenz are likely to result in an unacceptable rate of virological failure Therefore this study examines drug combinations which include two new nucleoside reverse transcriptase inhibitors NRTIs the NNRTI efavirenz and either one or two protease inhibitors which are known not to produce cross-resistance to nelfinavir
Patients are randomly selected to receive 1 of the following 4 treatment regimens
Arm A Ritonavir saquinavir efavirenz and 2 new NRTIs Arm B Indinavir efavirenz and 2 new NRTIs Arm C Amprenavir efavirenz and 2 new NRTIs AS PER AMENDMENT 32200 Patients have the option to increase the APV dose or to add low-dose ritonavir APV will continue to be provided by the study ritonavir will not be provided by the study Arm D Indinavir amprenavir efavirenz and 2 new NRTIs AS PER AMENDMENT 62899 All treatment regimens must include at least 1 new NRTI AS PER AMENDMENT 32200 ACTG 400 will continue to provide originally randomized study medications to all patients until approximately May 10 2000 regardless of virologic response Patients may also add antiretrovirals of their choice to this regimen not provided by the study Clinical assessments are taken at Weeks 2 4 8 12 16 and every 8 weeks thereafter for the duration of the study In addition 2 substudies are being conducted a drug-interaction substudy and a drug-exposure substudy AS PER AMENDMENT 32200 Both substudies are closed to accrual and their pharmacokinetics assessments are discontinued
Patients are randomly selected to receive 1 of the following 4 treatment regimens
Arm A Ritonavir saquinavir efavirenz and 2 new NRTIs Arm B Indinavir efavirenz and 2 new NRTIs Arm C Amprenavir efavirenz and 2 new NRTIs AS PER AMENDMENT 32200 Patients have the option to increase the APV dose or to add low-dose ritonavir APV will continue to be provided by the study ritonavir will not be provided by the study Arm D Indinavir amprenavir efavirenz and 2 new NRTIs AS PER AMENDMENT 62899 All treatment regimens must include at least 1 new NRTI AS PER AMENDMENT 32200 ACTG 400 will continue to provide originally randomized study medications to all patients until approximately May 10 2000 regardless of virologic response Patients may also add antiretrovirals of their choice to this regimen not provided by the study Clinical assessments are taken at Weeks 2 4 8 12 16 and every 8 weeks thereafter for the duration of the study In addition 2 substudies are being conducted a drug-interaction substudy and a drug-exposure substudy AS PER AMENDMENT 32200 Both substudies are closed to accrual and their pharmacokinetics assessments are discontinued
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 A5022s | Registry Identifier | DAIDS ES Registry Number | None |
| 11356 | REGISTRY | None | None |
| Substudy A5013s | None | None | None |