Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027339
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-12-04
Brief Title:
Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV
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 Study of the Predictive Value of Pharmacokinetic-Adjusted Phenotypic Susceptibility C12hIC50 on Antiretroviral Response to Ritonavir-Enhanced Protease Inhibitors in Subjects With Failure of Previous Protease Inhibitor-Based Regimens
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:
Because people infected with HIV strains that are resistant to anti-HIV drugs have fewer effective treatment options selecting an effective anti-HIV drug combination is difficult A combination of protease inhibitors PIs when added to a patients current anti-HIV therapy may decrease viral load and increase drug activity Tests that measure drug levels in the blood and tests to evaluate the drug resistance of HIV may also be helpful in choosing the best anti-HIV drug combination for a patient This study will determine whether using these tests to choose a drug combination and adding PIs to that combination will improve the patients response to anti-HIV therapy
Detailed Description:
Treatment options are limited for HIV infected individuals who have extensive treatment experience and harbor resistance to antiretrovirals ARVs from multiple drug classes Increasing the concentration of PIs in a regimen may be one way to provide more substantial ARV activity It is uncertain how combining specific PIs with RTV affects viral susceptibility and ARV effect The relationship of PI concentration eg Cmin to virus susceptibility IC50 may be a better predictor of treatment outcome than susceptibility alone This study will evaluate the predictive value of pharmacokinetic-adjusted phenotypic susceptibility C12hIC50 on ARV response to ritonavir RTV-boosted regimens in patients failing their current PI-containing regimens
Participants will have blood drawn during a screening visit for phenotypic assay and to determine viral load At study entry participants will discontinue their PIs while continuing to take their other ARVs Each participant and his or her doctor will choose to add one of three RTV-boosted regimens 1 indinavir IDV and RTV 2 fosamprenavir FPV and RTV or 3 lopinavir LPVRTV plus additional RTV Participants will take this regimen for 14 days On Day 14 patients will have a 12-hour pharmacokinetic evaluation On Day 15 patients will add tenofovir disoproxil fumarate TDF to their regimens and may choose to modify their other ARVs while continuing their RTV-boosted therapy Participants will have additional study visits at Weeks 4 8 16 and 24 Study visits will include a physical exam and blood and urine tests Participants will complete adherence questionnaires four times during the course of the study
Participants will have blood drawn during a screening visit for phenotypic assay and to determine viral load At study entry participants will discontinue their PIs while continuing to take their other ARVs Each participant and his or her doctor will choose to add one of three RTV-boosted regimens 1 indinavir IDV and RTV 2 fosamprenavir FPV and RTV or 3 lopinavir LPVRTV plus additional RTV Participants will take this regimen for 14 days On Day 14 patients will have a 12-hour pharmacokinetic evaluation On Day 15 patients will add tenofovir disoproxil fumarate TDF to their regimens and may choose to modify their other ARVs while continuing their RTV-boosted therapy Participants will have additional study visits at Weeks 4 8 16 and 24 Study visits will include a physical exam and blood and urine tests Participants will complete adherence questionnaires four times during the course of the study
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 |
|---|---|---|---|
| AACTG A5126 | Registry Identifier | DAIDS ES | None |
| 10079 | REGISTRY | None | None |
| ACTG A5126 | None | None | None |