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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00925535
First received: June 19, 2009
Last updated: September 17, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteers
 Drug: Lersivirine
Drug: Rifabutin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Rifabutin
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Lersivirine plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ] [ Designated as safety issue: No ]
  • Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ] [ Designated as safety issue: No ]

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

Enrollment: 18
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00925535

Locations
Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00925535     History of Changes
Other Study ID Numbers: A5271043
Study First Received: June 19, 2009
Last Updated: September 17, 2010
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
 Pharmacologic Actions
Antibiotics, Antitubercular
Antitubercular Agents

ClinicalTrials.gov processed this record on June 18, 2013