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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; Tuberculosis

Intervention: lopinavir/ritonavir (Drug); rifabutin (Drug)

Phase: Phase 1

Status: Terminated

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Angela Nilius, MD, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

Official title: A Comparison of the Bioavailability of Rifabutin With and Without Lopinavir/Ritonavir in Healthy Adult Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Analysis of pharmacokinetic variables will be computed for each sampling time and each parameter.

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Site Reference ID/Investigator# 11441, Waukegan, Illinois 60085, United States
Additional Information

Starting date: August 2008
Last updated: October 29, 2010

Page last updated: August 23, 2015

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