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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00925535

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 I

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:

MedlinePlus related topics: Drug Reactions HIV/AIDS Tuberculosis

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 February 09, 2012