Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096850
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-11-16
Brief Title:
Safety Tolerability and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Safety Tolerability and Pharmacokinetic Interactions of Atazanavir and Rifampin in Healthy 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:
Rifampin RIF is used for the treatment of tuberculosis TB an infectious disease that affects many people with HIV RIF was shown to lower concentrations and decrease the effectiveness of some anti-HIV drugs including the HIV protease inhibitor PI atazanavir ATV boosted with ritonavir RTV The purpose of this study is to determine the interactions between RTV-boosted ATV and evaluate the safety and tolerability of giving these drugs together in HIV uninfected adults
Detailed Description:
TB is common in resource-limited countries and people infected with HIV are especially at risk for TB infection The antituberculous drug RIF lowers plasma concentrations of PIs by increasing the activity of enzymes responsible for PI breakdown RIF has been shown to reduce PI effectiveness a particular concern for HIV infected patients who are also being treated for TB RTV has been shown to delay the plasma clearance of ATV and increase the plasma half-life of ATV This study will evaluate the safety tolerability and pharmacokinetic PK interactions of RTV-boosted ATV taken concurrently with RIF in HIV uninfected people
Medical and medication history a complete physical exam blood collection and an electrocardiogram ECG will occur at screening Participants will be enrolled in this study for 41 to 58 days there will be 3 dosing periods From Days 1 to 8 participants will receive 600 mg RIF every 24 hours From Days 9 to 19 participants will receive 300 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours From Days 20 to 27 participants will receive 400 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours Study visits will occur at entry at Days 5 8 11 14 19 23 and 27 and at an additional visit between Days 41 and 48 Blood and urine collection will occur at all visits A targeted physical exam an ECG and blood collection for PK analysis will occur at Days 8 19 and 27
Medical and medication history a complete physical exam blood collection and an electrocardiogram ECG will occur at screening Participants will be enrolled in this study for 41 to 58 days there will be 3 dosing periods From Days 1 to 8 participants will receive 600 mg RIF every 24 hours From Days 9 to 19 participants will receive 300 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours From Days 20 to 27 participants will receive 400 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours Study visits will occur at entry at Days 5 8 11 14 19 23 and 27 and at an additional visit between Days 41 and 48 Blood and urine collection will occur at all visits A targeted physical exam an ECG and blood collection for PK analysis will occur at Days 8 19 and 27
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 |
|---|---|---|---|
| 10021 | REGISTRY | None | None |
| ACTG A5213 | Registry Identifier | DAIDS ES | None |