A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

Phase 1

Terminated

• Conditions: HIV; Tuberculosis
• Interventions: Drug: lopinavir/ritonavir; Drug: rifabutin

• Registration Number: NCT00743470
• Lead Sponsor: Abbott

Brief Summary

The purpose of this study is to study the safety, tolerability and pharmacokinetics of rifabutin dosing with lopinavir/ritonavir tablets in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2008-10
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-29
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adult Male or Female 18-55 yrs.
• Subject has provided written consent.
• Subject is in general good health.
• If female, subject is postmenopausal.
• If female, subject is not pregnant and is not breast-feeding.
• Subject must use birth control methods or be surgically sterile.

Exclusion Criteria

• Subject is HAV-IgM, HBsAg or HIV Ab positive.
• Positive screen for drugs of abuse, alcohol, or smoking.
• Cannot be on any medication, including over the counter drugs.
• Cannot have previous history of alcohol or drug abuse.
• Cannot have history of any major diseases or disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C	lopinavir/ritonavir	Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
A, B	lopinavir/ritonavir	Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
A, B	rifabutin	Group 1 receives regimen A and B. A: Healthy volunteers, receiving one 150 mg rifabutin QD alone. B: Healthy volunteers, receiving 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.
C	rifabutin	Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.

Primary Outcome Measures

Name	Time	Method
Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.	Approximately 0.5 - 1 month
Analysis of safety measures including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.	Approximately 0.5 - 1 month

Trial Locations

Locations (1)

Site Reference ID/Investigator# 11441; 🇺🇸 Waukegan, Illinois, United States