Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults
NCT ID: NCT00096850
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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.
Atazanavir
From Days 9 to 19, participants will receive a 300 mg tablet orally daily. From Days 20 to 27, participants will receive a 400 mg tablet orally daily.
Rifampin
From Days 1 to 27, participants will receive a 600 mg tablet orally daily.
Ritonavir
From Days 9 to 19, participants will receive a 100 mg tablet orally daily. From Days 20 to 27, participants will receive a 100 mg tablet orally twice daily.
Interventions
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Atazanavir
From Days 9 to 19, participants will receive a 300 mg tablet orally daily. From Days 20 to 27, participants will receive a 400 mg tablet orally daily.
Rifampin
From Days 1 to 27, participants will receive a 600 mg tablet orally daily.
Ritonavir
From Days 9 to 19, participants will receive a 100 mg tablet orally daily. From Days 20 to 27, participants will receive a 100 mg tablet orally twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal creatinine clearance
* Willing to use acceptable means of contraception during the study and for at least 6 weeks after stopping study medications
Exclusion Criteria
* Active drug use or dependence that, in the opinion of the investigator, may interfere with the study
* Cannot stop consuming alcoholic beverages, grapefruit, or grapefruit juice for the duration of the study
* Cannot stop consuming coffee or caffeine-containing products for 12 hours prior to Day 8, 19, and 27 PK studies
* Serious illness that, in the opinion of the investigator, may interfere with the study
* Hospitalization for any reason within 14 days prior to study entry
* History of hypersensitivity to study drugs or their formulations
* Active or previous history of cardiovascular, kidney, liver, blood, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease. Patients with chronic illnesses such as hypertension, coronary heart disease, arthritis, diabetes, or chronic gastrointestinal conditions that may affect drug absorption are also excluded.
* ECG showing first-degree or greater heart block or a QT interval greater than 440 msec within 30 days of study entry
* Previous participation in this study
* Pregnancy or breastfeeding
18 Years
55 Years
ALL
Yes
Sponsors
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Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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David W. Haas, MD
Role: STUDY_CHAIR
Infectious Diseases, Vanderbilt University Medical Center
Locations
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Stanford CRS
Palo Alto, California, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States
Countries
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References
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Finch CK, Chrisman CR, Baciewicz AM, Self TH. Rifampin and rifabutin drug interactions: an update. Arch Intern Med. 2002 May 13;162(9):985-92. doi: 10.1001/archinte.162.9.985.
Fujiwara PI, Clevenbergh P, Dlodlo RA. Management of adults living with HIV/AIDS in low-income, high-burden settings, with special reference to persons with tuberculosis. Int J Tuberc Lung Dis. 2005 Sep;9(9):946-58.
Kashuba AD. Drug-drug interactions and the pharmacotherapy of HIV infection. Top HIV Med. 2005 Jun-Jul;13(2):64-9.
Musial BL, Chojnacki JK, Coleman CI. Atazanavir: a new protease inhibitor to treat HIV infection. Am J Health Syst Pharm. 2004 Jul 1;61(13):1365-74. doi: 10.1093/ajhp/61.13.1365.
Orrick JJ, Steinhart CR. Atazanavir. Ann Pharmacother. 2004 Oct;38(10):1664-74. doi: 10.1345/aph.1D394. Epub 2004 Sep 7.
Acosta EP, Kendall MA, Gerber JG, Alston-Smith B, Koletar SL, Zolopa AR, Agarwala S, Child M, Bertz R, Hosey L, Haas DW. Effect of concomitantly administered rifampin on the pharmacokinetics and safety of atazanavir administered twice daily. Antimicrob Agents Chemother. 2007 Sep;51(9):3104-10. doi: 10.1128/AAC.00341-07. Epub 2007 Jun 18.
Other Identifiers
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10021
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5213
Identifier Type: -
Identifier Source: secondary_id
A5213
Identifier Type: -
Identifier Source: org_study_id