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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Lersivirine
* Drug: Rifabutin
* Drug: Lersivirine
* Drug: Rifabutin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Lersivirine | Drug: Lersivirine<br>* 1000 mg once daily for 10 days<br>|
| Active Comparator: Treatment B<br>Rifabutin | Drug: Rifabutin<br>* 300 mg once daily for 10 days<br>|
| Experimental: Treatment C<br>Lersivirine and Rifabutin | Drug: Lersivirine<br>* 1000 mg once daily for 10 days<br>Drug: Rifabutin<br>* 300 mg once daily for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments |  | 58 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics HIV Tuberculosis Lersivirine UK-453, 061 Rifabutin, HIV Infections