Status:
COMPLETED
Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18-55 years
Phase:
NA
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 ant...
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 act...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00096850
End Date
December 1 2007
Last Update
November 1 2021
Active Locations (3)
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1
Stanford CRS
Palo Alto, California, United States, 94305-5107
2
The Ohio State Univ. AIDS CRS
Columbus, Ohio, United States, 43210
3
Vanderbilt Therapeutics CRS
Nashville, Tennessee, United States, 37203