HIV Infections Clinical Trial
Official title:
Safety, Tolerability, and Pharmacokinetic Interactions of Atazanavir and Rifampin in Healthy Volunteers
NCT number | NCT00096850 |
Other study ID # | A5213 |
Secondary ID | 10021ACTG A5213 |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Est. completion date | December 2007 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Note: As of 11/27/06, enrollment into Version 1.0 of the study is now closed. Any new study participants will enroll under Version 2.0. Inclusion Criteria: - HIV uninfected - 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: - Using or anticipating use of certain medications, including any medication metabolized by CYP3A - 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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State Univ. AIDS CRS | Columbus | Ohio |
United States | Vanderbilt Therapeutics CRS | Nashville | Tennessee |
United States | Stanford CRS | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | AIDS Clinical Trials Group |
United States,
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 Ag — View Citation
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. Review. — View Citation
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. Review. — View Citation
Kashuba AD. Drug-drug interactions and the pharmacotherapy of HIV infection. Top HIV Med. 2005 Jun-Jul;13(2):64-9. Review. — View Citation
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. Review. Erratum in: Am J Health Syst Pharm. 2004 Nov 1;61(21):2243. — View Citation
Orrick JJ, Steinhart CR. Atazanavir. Ann Pharmacother. 2004 Oct;38(10):1664-74. Epub 2004 Sep 7. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameters of ritonavir (RTV)-boosted ATV when administered concurrently with RIF | Throughout study | ||
Primary | Safety and tolerability of RTV-boosted ATV when coadministered with RIF | Throughout study | ||
Secondary | Pharmacokinetics of RIF | Throughout study | ||
Secondary | Copy number of cellular drug transporter RNA in peripheral blood mononuclear cells (PBMCs) | Throughout study | ||
Secondary | UDP-glucuronosyltransferase (UGT)-1A1 genotype | At study entry | ||
Secondary | Serum bilirubin concentration | Throughout study | ||
Secondary | urine thromboxane and prostacyclin concentrations | At study entry and first PK visit |
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