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

Abbott

Status and phase

Terminated

Phase 1

Conditions

Tuberculosis

HIV

Treatments

Drug: lopinavir/ritonavir

Drug: rifabutin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00743470

M10-457

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 2 patient groups

A, B

Experimental group

Description:

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.

Treatment:

Drug: rifabutin

Drug: lopinavir/ritonavir

Experimental group

Description:

Group 2 receives regimen C. C: 150 mg rifabutin QD+ two lopinavir/ritonavir 200/50 mg tablets BID.

Treatment:

Drug: rifabutin

Drug: lopinavir/ritonavir