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

Phase 1TerminatedNCT00743470

Abbott15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Tuberculosis

Interventions

lopinavir/ritonavirDRUG

lopinavir/ritonavir tablet; see arm for intervention description

rifabutinDRUG

rifabutin capsule; see arms for intervention description

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Site Reference ID/Investigator# 11441

Waukegan, Illinois, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: Approximately 0.5 - 1 month

Data from ClinicalTrials.gov

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