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Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00925535
First received: June 19, 2009
Last updated: September 17, 2010
Last verified: September 2010
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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 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Drug Reactions
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 ]
- Rifabutin and 25-O-desacetyl-rifabutin plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h [ Time Frame: 20 days ]
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 ]
| 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 (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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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
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:
| 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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017