Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021463
Status:
COMPLETED
Last Update Posted:
2011-02-28
First Post:
2001-07-14
Brief Title:
Changing to Nonprotease Inhibitor Treatment to Improve Side Effects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Randomized Open-Label Study of Switching to Protease Inhibitor-Sparing Regimens for Improvement of Metabolic Abnormalities
Status:
COMPLETED
Status Verified Date:
2003-01
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 learn whether changing from a type of anti-HIV drug called a protease inhibitor PI to another type of anti-HIV drug will help to lower the amount of fats or sugars in the blood
PIs have been effective at keeping HIV viral load amount of HIV in the blood down However some people who take PIs have higher than normal levels of fats andor sugars in the blood Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low
PIs have been effective at keeping HIV viral load amount of HIV in the blood down However some people who take PIs have higher than normal levels of fats andor sugars in the blood Doctors believe that switching to anti-HIV drugs that do not contain PIs will improve the abnormal side effects This study will test 3 different combinations of non-PI drugs to see which may improve side effects while keeping viral loads low
Detailed Description:
Protease inhibitor PI-containing antiretroviral regimens are potent suppressors of HIV replication Increasingly metabolic abnormalities such as hypercholesterolemia and triglyceridemia are associated with PI use reasons cited for switching to PI-sparing regimens Yet optimal switch regimens that take into account both improvements in side effects and continued virologic suppression have not been defined This study will compare the effect on chemical metabolic abnormalities of switching to an all nucleoside regimen versus dual nucleoside plus nonnucleoside reverse transcriptase inhibitor NNRTI therapy Determining the effects of each regimen on chemical metabolic abnormalities and maintenance of virologic suppression will define which of the switch strategies being studied improves metabolic abnormalities without compromising viral suppression
Patients are stratified on the basis of fasting non-HDL cholesterol and triglyceride levels and on ritonavir- or nonritonavir-containing pre-entry PI regimens Patients are assigned randomly to add to their pre-entry regimen 1 of the following 3 treatments Arm A - ABC Arm B - NVP or Arm C - EFV
Patients discontinue pre-entry PIs after Day 14 Patients are followed to determine the effect of the maintenance regimens on fasting non-high-density lipoprotein HDL cholesterol and triglycerides at Week 24 Fasting total cholesterol HDL cholesterol direct low-density lipoprotein and triglycerides are measured at Weeks 12 24 and 48 Fasting glucose insulin C-peptide apolipoproteins A-1 and B lipoprotein a and homocysteine are measured at Weeks 24 and 48 Anthropometrics body mass index and body image are measured at Weeks 12 24 and 48 HIV viral load is measured at Weeks 2 4 8 12 16 20 24 32 40 and 48 If HIV RNA stays below 200 copiesml therapy continues unchanged If confirmed HIV RNA of 200 copiesml or higher is found an HIV genotype is obtained providing the viral load is sufficient to yield results the best medical therapy is instituted not supplied by the study and off treatmenton study follow-up is continued If patients are intolerant to a study drug an alternate study drug ABC EFV or NVP supplied by the study is permitted and switched treatmenton study follow-up continued or the best medical therapy is instituted not supplied by the study and off treatmenton study follow-up is continued Patients are followed until the last patient enrolled has completed 48 weeks on study
Patients are stratified on the basis of fasting non-HDL cholesterol and triglyceride levels and on ritonavir- or nonritonavir-containing pre-entry PI regimens Patients are assigned randomly to add to their pre-entry regimen 1 of the following 3 treatments Arm A - ABC Arm B - NVP or Arm C - EFV
Patients discontinue pre-entry PIs after Day 14 Patients are followed to determine the effect of the maintenance regimens on fasting non-high-density lipoprotein HDL cholesterol and triglycerides at Week 24 Fasting total cholesterol HDL cholesterol direct low-density lipoprotein and triglycerides are measured at Weeks 12 24 and 48 Fasting glucose insulin C-peptide apolipoproteins A-1 and B lipoprotein a and homocysteine are measured at Weeks 24 and 48 Anthropometrics body mass index and body image are measured at Weeks 12 24 and 48 HIV viral load is measured at Weeks 2 4 8 12 16 20 24 32 40 and 48 If HIV RNA stays below 200 copiesml therapy continues unchanged If confirmed HIV RNA of 200 copiesml or higher is found an HIV genotype is obtained providing the viral load is sufficient to yield results the best medical therapy is instituted not supplied by the study and off treatmenton study follow-up is continued If patients are intolerant to a study drug an alternate study drug ABC EFV or NVP supplied by the study is permitted and switched treatmenton study follow-up continued or the best medical therapy is instituted not supplied by the study and off treatmenton study follow-up is continued Patients are followed until the last patient enrolled has completed 48 weeks on study
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 |
|---|---|---|---|
| AACTG A5103 | None | None | None |