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

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:

MedlinePlus related topics: Drug Reactions HIV/AIDS

Drug Information available for: Rifabutin

Genetic and Rare Diseases Information Center resources: Tuberculosis

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Antibiotics, Antitubercular	Antitubercular Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015