Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00925535

Enrollment

Registered

2009-06-22

Start date

2010-05-31

Completion date

2010-08-31

Last updated

2010-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics HIV Tuberculosis Lersivirine UK-453, 061 Rifabutin, HIV Infections

Brief summary

Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.

Interventions

DRUGLersivirine

1000 mg once daily for 10 days

DRUGRifabutin

300 mg once daily for 10 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor). * Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * Hypersensitivity/allergic reactions to any component of the study drugs.

Design outcomes

Primary

Measure	Time frame
Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h	20 days
Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h	20 days

Secondary

Measure	Time frame
Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments	58 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026