Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005762
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-05-25
Brief Title:
Drug Interactions of Amprenavir and Efavirenz in Combination With a Second Protease Inhibitor in HIV-Negative Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacokinetic Interaction Studies of Amprenavir APV Efavirenz EFV and a Second Protease Inhibitor in HIV-Seronegative Volunteers
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 measure the blood levels of amprenavir APV alone APV combined with efavirenz EFV and APVEFV combined with a third drug nelfinavir NFV indinavir IDV ritonavir soft gel capsules RTV sgc or saquinavir soft gel capsules SQV sgc
Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV infections Doctors need to know the best dosages of certain drugs when they are given in combination This study will measure the blood levels of APV alone APV combined with EFV and APVEFV plus a second PI in healthy volunteers It will study the safety and tolerance of these drugs
Anti-HIV therapy with 3 or 4 drugs is currently the recommended approach for treating HIV infections Doctors need to know the best dosages of certain drugs when they are given in combination This study will measure the blood levels of APV alone APV combined with EFV and APVEFV plus a second PI in healthy volunteers It will study the safety and tolerance of these drugs
Detailed Description:
Triple-drug antiretroviral regimens have become the recommended approach to therapy for HIV infection AS PER AMENDMENT 12400 The clinical use of multiple-drug antiretroviral regimens containing various combinations of nucleoside reverse transcriptase inhibitors NRTIs nonnucleoside reverse transcriptase inhibitors NNRTIs and protease inhibitors PIs has become a widespread approach to therapy for HIV infection especially for patients previously treated with PIs Since the introduction of PIs a greater awareness of the relationship between optimal suppression of viral replication genotypic resistance and viral rebound has led to the design of more potent antiretroviral drug combinations Two ACTG clinical trials addressing the issue of virologic failure utilize antiviral regimens that include 2 NRTIs 2 PIs one of which is APV and EFV NNRTI Although this drug combination is logical there is limited PK data to guide the dosing selection This study enrolls healthy volunteers to obtain PK profiles and metabolic assessments of APVEFV before and after the addition of a second PI AS PER AMENDMENT 12400 APV alone APV combined with EFV and APVEFV combined with a second PI
Upon study entry volunteers receive APV plus EFV for 2 weeks AS PER AMENDMENT 12400 Volunteers receive a single dose of APV alone on Day 0 EFV alone on Days 1 to 10 and APV combined with EFV on Days 11 to 13 After 2 weeks AS PER AMENDMENT 12400 After completion of the second PK visit volunteers are randomized to 1 of 5 treatment arms to add a second PI to the APVEFV drug combination for 2 more weeks AS PER AMENDMENT 12400 for at least 1 week The treatment arms are as follows
Arm A control arm APV and EFV alone Arm B APV and EFV plus IDV AS PER AMENDMENT 12400 APV and EFV plus NFV Arm C APV and EFV plus NFV AS PER AMENDMENT 12400 APV and EFV plus IDV Arm D APV and EFV plus RTV sgc Arm E APV and EFV plus SQV sgc On Day 14 15 or 16 volunteers return to the clinic for PK testing following the dual-drug regimen and again on Day 29 30 or 31 following the triple-drug regimen or continued dual-drug regimen for Arm A AS PER AMENDMENT 12400 Volunteers attend clinics for PK testing on Days 0 and 1 first visit after taking the dual-drug regimen for at least 3 days second visit eg on Day 14 or after and after taking the triple-drug regimen or if in Arm A after continuing on the dual-drug regimen for at least 7 days third visit Before each PK testing volunteers complete an Adherence Questionnaire AS PER AMENDMENT 12400 The Adherence Questionnaire is administered at the second and third PK visits Volunteers maintain a food diary Two to three weeks after completing the drug regimen AS PER AMENDMENT 12400 Within 2-3 weeks after the third PK visit volunteers return to the clinic for evaluations and urine and blood sampling
Upon study entry volunteers receive APV plus EFV for 2 weeks AS PER AMENDMENT 12400 Volunteers receive a single dose of APV alone on Day 0 EFV alone on Days 1 to 10 and APV combined with EFV on Days 11 to 13 After 2 weeks AS PER AMENDMENT 12400 After completion of the second PK visit volunteers are randomized to 1 of 5 treatment arms to add a second PI to the APVEFV drug combination for 2 more weeks AS PER AMENDMENT 12400 for at least 1 week The treatment arms are as follows
Arm A control arm APV and EFV alone Arm B APV and EFV plus IDV AS PER AMENDMENT 12400 APV and EFV plus NFV Arm C APV and EFV plus NFV AS PER AMENDMENT 12400 APV and EFV plus IDV Arm D APV and EFV plus RTV sgc Arm E APV and EFV plus SQV sgc On Day 14 15 or 16 volunteers return to the clinic for PK testing following the dual-drug regimen and again on Day 29 30 or 31 following the triple-drug regimen or continued dual-drug regimen for Arm A AS PER AMENDMENT 12400 Volunteers attend clinics for PK testing on Days 0 and 1 first visit after taking the dual-drug regimen for at least 3 days second visit eg on Day 14 or after and after taking the triple-drug regimen or if in Arm A after continuing on the dual-drug regimen for at least 7 days third visit Before each PK testing volunteers complete an Adherence Questionnaire AS PER AMENDMENT 12400 The Adherence Questionnaire is administered at the second and third PK visits Volunteers maintain a food diary Two to three weeks after completing the drug regimen AS PER AMENDMENT 12400 Within 2-3 weeks after the third PK visit volunteers return to the clinic for evaluations and urine and blood sampling
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 |
|---|---|---|---|
| ACTG A5043 | Registry Identifier | DAIDS ES | None |
| 10671 | REGISTRY | None | None |