Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00046033
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2002-09-18
Brief Title:
Comparing Standard-Dose Versus Adjusted-Dose LopinavirRitonavir Therapy in HIV-Infected Persons With Drug Resistance
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 Study Comparing Fixed-Dose Versus Concentration-Adjusted LopinavirRitonavir Therapy in HIV-Infected Subjects on Salvage Therapy
Status:
COMPLETED
Status Verified Date:
2005-05
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 see if adjusting the dose of lopinavirritonavir LPVr has a better effect on lowering HIV viral load the amount of HIV in the blood compared to taking the standard FDA-approved LPVr dose This study will also compare the safety and tolerability of these two types of dosing
Detailed Description:
Antiretroviral drugs may fail to suppress HIV unless there are adequate amounts of those drugs in the blood By monitoring the amounts of drugs in the blood and adjusting doses to achieve optimal drug concentrations response to antiretroviral drugs may improve especially in patients who have failed previous regimens This study is designed to evaluate drug monitoring and dose adjustment of protease inhibitors PIs in heavily treatment-experienced patients
Patients will be randomized to receive either a standard dose of LPVr Arm A or a concentration-adjusted dose of LPVr Arm B Concentration-adjusted dosing means that the dose of ritonavir or lopinavir may be increased based on the amount of lopinavir measured in the blood and the results of a drug resistance test All patients start the study taking LPVr tenofovir disoproxil fumarate TDF 0 to 2 additional nucleoside reverse transcriptase inhibitors NRTIs and saquinavir SQV or amprenavir APV Only LPVr TDF and SQV will be provided by the study Other medications taken as part of the antiretroviral regimen must be obtained outside the study
Patients in Arm A will take the usual approved dose of LPVr for the first 24 weeks At Week 24 patients with high viral loads will come to the clinic for a 12-hour LPV blood level measurement to see if the level of LPV needs to be increased If it does an additional capsule of ritonavir will be added to the regimen to boost the level of LPV
Patients in Arm B will have a series of blood draws over a 12-hour period in the clinic around 14 days after starting the study to find out if their LPV level needs to be increased If the LPV level needs to be raised an additional capsule of ritonavir will be added to the regimen to boost the level of LPV Patients who had their ritonavir dose adjusted will return to have another 12-hour blood draw around Week 5 If the LPV level still needs to be changed an additional capsule of LPVr will be added to the regimen A third 12-hour blood draw will be performed around Week 8 if a second dose adjustment was necessary
During the study patients will visit the clinic weekly through Week 6 again at Week 8 then every 4 weeks thereafter through Week 32 Patients will have blood drawn at certain visits to test for LPV level viral load CD4 count fasting lipids and glucose and drug resistance
Patients will be randomized to receive either a standard dose of LPVr Arm A or a concentration-adjusted dose of LPVr Arm B Concentration-adjusted dosing means that the dose of ritonavir or lopinavir may be increased based on the amount of lopinavir measured in the blood and the results of a drug resistance test All patients start the study taking LPVr tenofovir disoproxil fumarate TDF 0 to 2 additional nucleoside reverse transcriptase inhibitors NRTIs and saquinavir SQV or amprenavir APV Only LPVr TDF and SQV will be provided by the study Other medications taken as part of the antiretroviral regimen must be obtained outside the study
Patients in Arm A will take the usual approved dose of LPVr for the first 24 weeks At Week 24 patients with high viral loads will come to the clinic for a 12-hour LPV blood level measurement to see if the level of LPV needs to be increased If it does an additional capsule of ritonavir will be added to the regimen to boost the level of LPV
Patients in Arm B will have a series of blood draws over a 12-hour period in the clinic around 14 days after starting the study to find out if their LPV level needs to be increased If the LPV level needs to be raised an additional capsule of ritonavir will be added to the regimen to boost the level of LPV Patients who had their ritonavir dose adjusted will return to have another 12-hour blood draw around Week 5 If the LPV level still needs to be changed an additional capsule of LPVr will be added to the regimen A third 12-hour blood draw will be performed around Week 8 if a second dose adjustment was necessary
During the study patients will visit the clinic weekly through Week 6 again at Week 8 then every 4 weeks thereafter through Week 32 Patients will have blood drawn at certain visits to test for LPV level viral load CD4 count fasting lipids and glucose and drug resistance
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