Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: AIDS Clinical Trials Group
• Treatments: Atazanavir Sulfate; Rifampin; Ritonavir

Criteria

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