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

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ClinicalTrials.gov Identifier: NCT00925535
Recruitment Status : Completed
First Posted : June 22, 2009
Last Update Posted : September 21, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Lersivirine Drug: Rifabutin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Randomized, 3-Way Crossover Study To Estimate The Interaction Between Multiple Dose Rifabutin And Lersivirine (UK-453,061) In Healthy Subjects
Study Start Date : May 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Rifabutin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treatment A
Lersivirine
 Drug: Lersivirine
1000 mg once daily for 10 days
Active Comparator: Treatment B
Rifabutin
 Drug: Rifabutin
300 mg once daily for 10 days
Experimental: Treatment C
Lersivirine and Rifabutin
 Drug: Lersivirine
1000 mg once daily for 10 days

Drug: Rifabutin
300 mg once daily for 10 days


Outcome Measures
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Primary Outcome Measures :
  1. Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]
  2. Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12 lead ECG and laboratory safety assessments [ Time Frame: 58 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925535


Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00925535     History of Changes
Other Study ID Numbers: A5271043
First Posted: June 22, 2009    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010

Keywords provided by Pfizer:
Pharmacokinetics HIV Tuberculosis Lersivirine UK-453
061 Rifabutin
HIV Infections

Additional relevant MeSH terms:
Rifabutin
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antitubercular
Antitubercular Agents